Evaluate the Time of Pain Relief of Fast Acting Aspirin Versus Acetaminophen in Subjects Diagnosed With Sore Throat Pain

NCT01453400 | Completed Phase 3

• 1 other identifier: 15772
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate the onset of relief provided by a single, oral dose of fast release aspirin 1000 mg compared to acetaminophen 1000 mg and placebo in subjects with sore throat pain.

Conditions

Pharyngitis

Keywords

aspirin; acetylsalicylic acid; pharyngitis; sore throat

Outcome Measures

Primary Outcomes (1)

• Time to meaningful pain relief from the Sore Throat Pain Intensity Scale (STPIS) 100 mm visual analog scale

  Up to two hours

Secondary Outcomes (5)

• Global assessment of the investigational product as a pain reliever by grading from 0 to 4 (from poor to excellent)

  Two hours postdose or immediately before the intake of rescue medication

• Time to first perceptible relief (defined as the time when the subject presses the first stopwatch)

  Up to two hours

• Time weighted sum of pain intensity differences (PID) scores over first hour

  Up to one hour

• Time weighted sum of pain intensity differences (PID) scores over 2 hours

  Up to two hours

• Percentage difference from baseline Sore Throat Pain Intensity Scale (STPIS) to STPIS at time of meaningful relief

  Up to two hours

Study Arms (3)

Arm 1

EXPERIMENTAL

Drug: Acetylsalicylic Acid (Aspirin, BAY1019036) + placebo

Arm 2

ACTIVE COMPARATOR

Drug: Acetaminophen + placebo

Arm 3

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Acetylsalicylic Acid (Aspirin, BAY1019036) + placebo DRUG

Single dose, 2 x 500 mg fast release aspirin tablets (1000 mg) + 2 x placebo acetaminophen caplets

Arm 1

Acetaminophen + placebo DRUG

Single dose, 2 x 500 mg Acetaminophen caplets (1000 mg) + 2 x placebo fast release Aspirin tablets

Arm 2

Placebo DRUG

Single dose, 2 x placebo Acetaminophen caplets + 2 x placebo fast release Aspirin tablets

Arm 3

Eligibility Criteria

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

You may qualify if:

• Healthy, ambulatory, male and female subjects ≥ 18 years of age
• Presence of sore throat due to upper respiratory tract infection (URTI)
• Onset of sore throat pain within six days of the screening period
• Baseline sore throat pain intensity score ≥ 60 mm on the Sore Throat Pain Intensity Scale
• Have a score ≥ 5 on the Tonsillopharyngitis Assessment
• Female subjects of childbearing potential who are currently sexually active must be using a medically acceptable form of birth control for at least one month prior to screening (three months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Nuvaring, Depo-Provera, or double-barrier and have a negative pregnancy test at screening/treatment period. Female subjects of non-childbearing potential must be amenorrheic for at least two years or had a hysterectomy and/or bilateral oophorectomy.
• Understand the pain rating assessments

You may not qualify if:

• History of hypersensitivity to aspirin, salicylates, other nonsteroidal anti-inflammatory drugs, acetaminophen, opioid analgesics, and similar drugs
• Use of any "cold medication" (i.e. decongestants, antihistamines, expectorants, antitussives) within four hours preceding administration of the investigational product
• Use of any immediate release analgesic/antipyretic within four hours or use of any sustained release or long-acting analgesic/antipyretic within twelve hours preceding administration of the investigational product
• Consumption of alcoholic beverages, or foods and beverages containing xanthines within two hours prior to administration of the investigational product
• Use of any sore throat lozenges, sprays, cough drops, menthol-containing products within one hour preceding administration of the investigational product
• Presence of cough that causes throat discomfort
• Presence of mouth-breathing or any respiratory condition that, in the Investigator's judgment, could compromise breathing
• Evidence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies for which aspirin or acetaminophen is contraindicated
• Relevant concomitant disease such as medically uncontrolled asthma (exercise induced asthma is permitted), chronic sinusitis or nasal structural abnormalities causing greater than fifty percent obstruction
• History of gastrointestinal bleeding or perforation related to previous non-steroidal anti-inflammatory therapy.
• Current or past history of a bleeding disorder
• Self reported alcoholism or drug abuse within two years prior to screening or routine consumption of three or more alcohol containing beverages per day
• Habituation to analgesic drugs or tranquilizers (i.e., routine use of five or more times per week for greater than three weeks)
• Acute illness, local infection, or disease (other than URTI with pharyngeal infection) that can interfere with the conduct of the study
• Current use of blood thinning (anticoagulant), low dose aspirin, or steroid drug

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Storrs, Connecticut, 06269-2011, United States

Location

Related Publications (1)

• Voelker M, Schachtel BP, Cooper SA, Gatoulis SC. Efficacy of disintegrating aspirin in two different models for acute mild-to-moderate pain: sore throat pain and dental pain. Inflammopharmacology. 2016 Feb;24(1):43-51. doi: 10.1007/s10787-015-0253-0. Epub 2015 Nov 24.

  PMID: 26603742 DERIVED

MeSH Terms

Conditions

Pharyngitis

Interventions

Aspirin; Acetaminophen

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2011
• First Posted: October 17, 2011
• Study Start: September 27, 2011
• Primary Completion: April 5, 2012
• Study Completion: April 6, 2012
• Last Updated: December 7, 2018

Record last verified: 2018-12

Locations

US (1)