Conditions: Constipation
Keywords: Drug therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 204
Healthy volunteers: no

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.

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 approximately 204 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups, such that equal numbers of subjects will be in each treatment group-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 Russia. 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.

Arms:
arm 1: Lubiprostone 24 μg, capsules, orally, twice daily, under fed conditions, for 4 weeks. arm 2: Lubiprostone placebo-matching capsules, orally, twice daily, under fed conditions, for 4 weeks.

Interventions: intervention 1: Lubiprostone intervention 2: Placebo
Intervention descriptions: intervention 1: Lubiprostone capsules intervention 2: Lubiprostone placebo-matching capsules

Protocol document: