A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lubiprostone for the Treatment of Chronic Idiopathic Constipation
Overview
- Phase
- Phase 3
- Intervention
- Lubiprostone
- Conditions
- Chronic Idiopathic Constipation
- Sponsor
- Takeda
- Enrollment
- 156
- Primary Endpoint
- Spontaneous Bowel Movement (SBM) Frequency at Week 1
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study was 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.
Detailed Description
The drug being tested in this study is called lubiprostone. Lubiprostone is being tested to treat people who have chronic idiopathic constipation. This study will look at the frequency of spontaneous bowel movements (SBMs) in people who take lubiprostone compared to placebo. The study will enroll 150 participants. Participants will be randomly assigned (by chance, like flipping a coin) equally to one of the two treatment groups, which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need): * Lubiprostone 24 μg * Placebo (dummy inactive pill) - this is a capsule that looks like the study drug but has no active ingredient All participants will be asked to take one capsule with breakfast and one capsule with dinner each day throughout the study. All participants will be asked to record each time they have a SBM and all details of each SBM (including the consistency of the stool and the difficulty they have in passing it) in a diary. This multi-center trial will be conducted in South Korea. The overall time to participate in this study is 8 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone 14 days after last dose of study drug for a follow-up assessment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •In the opinion of the investigator, the participant 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 sudden bowel movement (SBM) frequency of less than 3 times per week on average for 6 months or longer and for whom the SBM frequency is confirmed to meet inclusion criteria 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 19 years or older, at the time of signing an informed consent.
Exclusion Criteria
- •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, the participant 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.
Arms & Interventions
Lubiprostone 24 μg
Lubiprostone 24 μg, capsules, orally, twice daily, under fed conditions, for 4 weeks.
Intervention: Lubiprostone
Placebo
Lubiprostone placebo-matching capsules, orally, twice daily, under fed conditions, for 4 weeks.
Intervention: Placebo
Outcomes
Primary Outcomes
Spontaneous Bowel Movement (SBM) Frequency at Week 1
Time Frame: Week 1
A SBM was defined as any bowel movement (BM) that does not occur within 24 hours after rescue medication use (laxative, suppository, or enema). Participants will be given a diary to complete at home where they will record all details of each SBM including the consistency of the stool and the difficulty they have in passing it.
Secondary Outcomes
- 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)
- Weekly Responder Rate(Weeks 1, 2, 3 and 4)