A Clinical Evidence Study Evaluating Quality of Life Parameters Following Treatment With Robitussin

NCT06716645 | Completed Phase 4 Results

• 1 other identifier: 300233
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this Real-World Evidence study is to generate real world data from participants with cough associated with the common cold, evaluating the effects in two arms with commercially available cough syrups on health-related quality of life (QoL). Arm 1 includes one cough syrup (which can be used day or night) and Arm 2 includes the daytime cough syrup and a nighttime cough syrup.

Conditions

Common Cold; Cough

Outcome Measures

Primary Outcomes (22)

• Adjusted Mean Change From Baseline in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Total Score

  The WURSS was an evaluative illness-specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. Participants rated their cold symptoms (10 questions) and Quality of Life (QoL) related 9 questions using WURSS-21. The responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptoms/Not at all and 7=Severe symptoms/Severely. Thus, the minimum and maximum possible total scores were 0 and 133 respectively, where higher total scores indicated more negative impact on symptoms and quality of life. Change from Baseline was calculated as each post-Baseline value minus Baseline value. EOT was defined as the day when the participant ceased study involvement because they no longer required relief from their cough/cold symptoms or the participant reached Day 7 (Or their last available questionnaire information).

  Baseline and up to Day 7 or End of Treatment (EOT)

• Adjusted Mean Change From Baseline in WURSS-21 Total Symptom Domain Score

  The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The symptom domain of WURSS-21 consisted of 10 questions. Participants rated their cold symptoms related questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptoms and 7=Severe. Thus, the minimum and maximum possible total score was 0 and 70 respectively, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.

  Baseline and up to Day 7 or EOT

• Adjusted Mean Change From Baseline in WURSS-21 Total QoL Domain Score

  The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated their QoL related questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 63 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.

  Baseline and up to Day 7 or EOT

• Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Cough

  The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.

  Baseline and up to Day 7 or EOT

• Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Runny Nose

  The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.

  Baseline and up to Day 7 or EOT

• Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Plugged Nose

  The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.

  Baseline and up to Day 7 or EOT

• Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Sneezing

  The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.

  Baseline and up to Day 7 or EOT

• Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Sore Throat

  The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.

  Baseline and up to Day 7 or EOT

• Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Scratchy Throat

  The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.

  Baseline and up to Day 7 or EOT

• Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Hoarseness

  The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms include runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.

  Baseline and up to Day 7 or EOT

• Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Head Congestion

  The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.

  Baseline and up to Day 7 or EOT

• Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Chest Congestion

  The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.

  Baseline and up to Day 7 or EOT

• Mean Change From Baseline in Each of the WURSS-21 Symptom Scores: Feeling Tired

  The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The individual symptoms included runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion and feeling tired. Participants rated each of the 10 individual symptom domain questions and the responses were evaluated on a scale ranging from 0 to 7, where 0=Do not have symptom and 7=Severe. Thus, the minimum and maximum score for each symptom domain question was 0 and 7, where higher scores indicated more negative impact on symptoms. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.

  Baseline and up to Day 7 or EOT

• Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Think Clearly

  The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.

  Baseline and up to Day 7 or EOT

• Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Sleep Well

  The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 7 respectively, where higher scores indicate more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.

  Baseline and up to Day 7 or EOT

• Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Breathe Easily

  The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.

  Baseline and up to Day 7 or EOT

• Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Walk, Climb Stairs, Exercise

  The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.

  Baseline and up to Day 7 or EOT

• Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Accomplish Daily Activities

  The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.

  Baseline and up to Day 7 or EOT

• Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Work Outside the Home

  The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.

  Baseline and up to Day 7 or EOT

• Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Work Inside the Home

  The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.

  Baseline and up to Day 7 or EOT

• Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Interact With Others

  The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.

  Baseline and up to Day 7 or EOT

• Mean Change From Baseline in Each of the WURSS-21 QoL Questions Scores: Live Your Personal Life

  The WURSS was an evaluative illness specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). WURSS-21 was the short version of this validated survey. The QoL domain of WURSS-21 consisted of 9 questions. Participants rated each QoL questions indicating how cold interfered with their ability to perform daily activities, and the responses were evaluated on a scale ranging from 0 to 7, where 0=Not at all and 7=Severely. Thus, the minimum and maximum possible total scores were 0 and 7 respectively, where higher scores indicated more negative impact on QoL. Baseline was defined as Day 0. Change from Baseline was calculated as each post-Baseline value minus Baseline value.

  Baseline and up to Day 7 or EOT

Secondary Outcomes (11)

• Mean Change From Baseline in QoL Factors Score Assessed Using Specific QoL Questions: Social Activities

  Baseline and up to Day 7 or EOT

• Mean Change From Baseline in QoL Factors Score Assessed Using Specific QoL Questions: Self-conscious Around People

  Baseline and up to Day 7 or EOT

• Mean Change From Baseline in QoL Factors Score Assessed Using Specific QoL Questions: Coughing in Public

  Baseline and up to Day 7 or EOT

• Mean Change From Baseline in QoL Factors Score Assessed Using Specific QoL Questions: Falling Asleep

  Baseline and up to Day 7 or EOT

• Mean Change From Baseline in QoL Factors Score Assessed Using Specific QoL Questions: Sleeping Through the Night

  Baseline and up to Day 7 or EOT

Study Arms (2)

Robitussin Cough Syrup (Daytime)

EXPERIMENTAL

Participants will be instructed to take up to 20 milliliters (ml) of Robitussin Maximum Strength Cough and Chest Congestion DM syrup orally (not to exceed 6 doses in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurs first.

Drug: Robitussin Maximum Strength Cough and Chest Congestion DM

Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime)

EXPERIMENTAL

Participants will be instructed to take up to 20 ml of Robitussin Maximum Strength Cough and Chest Congestion DM syrup and up to 20 ml of Robitussin Maximum Strength Nighttime Cough DM syrup orally (not to exceed 4 doses of daytime + 1 dose of nighttime or 3 doses of daytime + 2 doses of nighttime in any 24-hour period) for up to 8 days or until resolution of symptoms, whichever occurs first.

Drug: Robitussin Maximum Strength Cough and Chest Congestion DM; Drug: Robitussin Maximum Strength Nighttime Cough DM

Interventions

Robitussin Maximum Strength Cough and Chest Congestion DM DRUG

Dextromethorphan Hydrobromide, United States Pharmacopeia (USP) 20 milligram (mg) and Guaifenesin, USP 400 mg

Robitussin Cough Syrup (Daytime)

Robitussin Maximum Strength Nighttime Cough DM DRUG

Dextromethorphan Hydrobromide, USP 30 mg and Doxylamine Succinate, USP 12.5 mg

Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant provides a signed and dated electronic informed consent document indicating that the participant has been informed of and consents to all pertinent aspects of the study, before any assessment is performed and participant has reviewed and is willing to follow the product label.
• Participant aged 18 years or older at the time of electronic consent, inclusive of all ethnicities, races and gender identities.
• Participant reporting initiation of cough symptoms within 48 hours prior to initiation of the virtual visit.
• Participant reporting a minimum score of 5 (moderate) for cough associated with common cold symptoms and at least one other symptom of common cold (at least mild score of 3) as per the WURSS-21 symptom domains.
• Participant reporting at least one night's sleep has been disrupted in the previous 2 nights due to the symptoms of common cold.
• Participant who is willing to self-treat their cough using the study treatment.
• Participant who is in good general and mental health.
• Participant who resides in the United States (except for Hawaii and Alaska).
• Participant who owns a mobile device with access to stable internet connection and is willing to use their device to complete study surveys and assessments per the schedule of events.
• Participant who has not taken any cough products containing dextromethorphan, guaifenesin, or doxylamine (example, Robitussin, Delsym, Vicks, Mucinex), or cough drops/lozenges containing benzocaine or menthol (example, Cepacol, Halls, Ricola) or any natural cough products during the study.

You may not qualify if:

• Have a history of allergies (example, rash, hives, difficulty breathing, swelling of face, lips, tongue, or throat) to any medication or any kind or sensitivity to ingredients in pain, cough, cold, and flu products; including the following active ingredients found in the Research products:
• Active Ingredients - dextromethorphan, guaifenesin, doxylamine.
• Inactive Ingredients - anhydrous citric acid, carboxymethylcellulose sodium, FD\&C blue no. 1, FD\&C red no. 40, glycerin, liquid glucose, menthol, natural and artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, triacetin, xanthan gum.
• Participant who is currently taking medications that may interact with the study products.
• Participant who is pregnant, lactating, or plans to be pregnant or lactating during the course of the study (self-report).
• Participant who has taken any cough products containing dextromethorphan, guaifenesin, or doxylamine (example, Robitussin, Delsym, Vicks, Mucinex), or cough drops/lozenges containing benzocaine or menthol (example, Cepacol, Halls, Ricola) or any natural cough products within 7 days prior to the virtual visit.
• Have previously been diagnosed with:
• prostate gland enlargement or difficulty urinating.
• glaucoma (excessive pressure inside your eyes).
• asthma, chronic bronchitis, chronic cough or chronic lung disease (difficulty in breathing and cough that won't go away).
• Pneumonia (within the last 6 months).
• Coronavirus disease (COVID-19) (within the last month).
• Are taking medication(s) to treat - psychiatric / mental health conditions (example, anxiety, depression) or Parkinson's disease. Medications such as:
• \. Monoamine oxidase inhibitor (MAOI) \[example, Azilect, Emsam, Marplan, Nardil\] or have stopped them within the last 2 weeks per their doctor's advice.
• Are currently taking sedatives or tranquilizers (example, Ambien, Xanax, Klonopin).

Sponsors & Collaborators

• HALEON: lead

Study Sites (1)

Lindus Health Limited

New York, New York, 10017, United States

Location

MeSH Terms

Conditions

Common Cold; Cough

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Haleon Response Center
• Organization: HALEON

ww.clinical-trial-register@haleon.com

+441932959500

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 4, 2024
• Study Start: December 4, 2024
• Primary Completion: February 14, 2025
• Study Completion: February 14, 2025
• Last Updated: February 20, 2026
• Results First Posted: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension can be granted, when justified, for up to another 12 months.

Locations

US (1)