Lubiprostone for the Treatment of Chronic Idiopathic Constipation

NCT02651155 | Completed Phase 3 Results

• 2 other identifiers: Lubiprostone-3001U1111-1170-0417
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 12

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of oral administration of lubiprostone 24 μg twice daily (BID) for 4 weeks in participants with chronic idiopathic constipation (CIC) compared with placebo.

Conditions

Constipation

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (1)

• Spontaneous Bowel Movement (SBM) Frequency at Week 1

  A SBM is defined as any bowel movement (BM) that does not occur within 24 hours after rescue medication use (laxative, suppository, or enema). SBM frequency data was collected in a diary. Participants were given a diary to complete at home where they recorded the date and time of each BM.

  Week 1

Secondary Outcomes (5)

• SBM Frequency at Weeks 2, 3 and 4

  Weeks 2, 3 and 4

• Percentage of Participants Who Had a SBM Within 24 Hours After the First Dose of Study Medication

  Up to 24 hours after the first dose of study medication

• Mean Degree of Straining Score

  Weeks 1, 2, 3 and 4

• Mean Degree Stool Consistency Score

  Weeks 1, 2, 3 and 4

• Weekly Abdominal Symptoms Score

  Weeks 1, 2, 3 and 4

Study Arms (2)

Lubiprostone 24 μg

EXPERIMENTAL

Lubiprostone 24 μg, capsules, orally, twice daily, under fed conditions, for 4 weeks.

Drug: Lubiprostone

Placebo

PLACEBO COMPARATOR

Lubiprostone placebo-matching capsules, orally, twice daily, under fed conditions, for 4 weeks.

Drug: Placebo

Interventions

Lubiprostone DRUG

Lubiprostone capsules

Lubiprostone 24 μg

Placebo DRUG

Lubiprostone placebo-matching capsules

Placebo

Eligibility Criteria

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

You may qualify if:

• In the opinion of the investigator, is capable of understanding and complying with protocol requirements.
• The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
• Has a history of constipation defined as having spontaneous bowel movement (SBM) frequency of less than 3 times per week on average for 6 months or longer and for whom the same SBM frequency is observed during the Screening Period.
• Has had 1 or more of the symptoms associated with SBM (described below) for 6 months or longer at the start of Screening:
• Scybalum stool or hard feces in at least 1 out of every4 bowel movements.
• Sensation of incomplete evacuation in at least 1 out of every 4 bowel movements.
• Straining in at least 1 out of every 4 bowel movements.
• Rarely has loose stools without the use of laxatives.
• Is willing and able to keep a diary on his/her own and willing and able to complete a questionnaire.
• Is male or female and aged 18 years or older, at the time of signing an informed consent.
• A female participant of childbearing potential who is sexually active agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and 14 days after the last dose of study drug.

You may not qualify if:

• Has received any investigational compound within 30 days prior to Screening.
• Has received lubiprostone in a previous clinical study or as a therapeutic agent.
• Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
• Has, in the judgment of the investigator, clinically significant abnormal hematological parameters of hemoglobin, hematocrit, or erythrocytes at Screening.
• Has a history or clinical manifestations of significant mechanical obstruction (intestinal obstruction due to tumor, hernia etc).
• Has a history of hypersensitivity or allergies to lubiprostone or any of its excipients.
• Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the Screening Visit.
• Is required to take excluded medications.
• If female, is pregnant or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period.
• Participant whose constipation is considered to be due to drugs or to whom a prohibited concomitant medication has been administered.
• Is having chronic constipation due to a secondary cause (medications, diabetes mellitus, hypothyroidism, depression, etc.)
• Has sufficient criteria for irritable bowel syndrome (IBS) or functional defecation disorder.
• SBM frequency is 3 or more per week.
• SBM frequency has been less than 3 times per week for less than 6 months in duration or whose symptoms associated with SBM have been present for less than 6 months (hard feces, sensation of incomplete evacuation, or straining).
• Received treatment with a rescue medication within 24 hours prior to the first dose on the morning of Day1: bisacodyl suppository, which is a standard laxative, glycerin enema, or any other rescue medication.

Sponsors & Collaborators

• Takeda: lead

Study Sites (12)

Unknown Facility

Saint Petersburg, Pushkin, Russia

Location

Unknown Facility

Barnaul, Russia

Location

Unknown Facility

Kazan', Russia

Location

Unknown Facility

Kemerovo, Russia

Location

Unknown Facility

Krasnodar, Russia

Location

Unknown Facility

Moscow, Russia

Location

Unknown Facility

Novosibirsk, Russia

Location

Unknown Facility

Omsk, Russia

Location

Unknown Facility

Saint Petersburg, Russia

Location

Unknown Facility

Samara, Russia

Location

Unknown Facility

Ulyanovsk, Russia

Location

Unknown Facility

Yaroslavl, Russia

Location

MeSH Terms

Conditions

Constipation

Interventions

Lubiprostone

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alprostadil; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director Clinical Science

  Takeda

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: January 7, 2016
• First Posted: January 8, 2016
• Study Start: March 2, 2016
• Primary Completion: January 11, 2017
• Study Completion: January 11, 2017
• Last Updated: August 13, 2018
• Results First Posted: August 13, 2018

Record last verified: 2017-11

Locations

RU (12)