Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lubiprostone · 8 trials · 5 indications
Monthly responder: \>=Moderately relieved symptoms 4 weeks/month or Significantly relieved \>= 2 weeks/month IF: Rescue med use did not increase during the month; AND did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month. Overall responder: responder for at least 2/3 months
A SBM is defined as any bowel movement (BM) that does not occur within 24 hours after rescue medication use (laxative, suppository, or enema). Participants were given a diary to complete at home where they have recorded all details of each SBM including the consistency of the stool and the difficulty they have in passing it.
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.
SBM is defined as any bowel movement (BM) that did not occur within the 24-hour period following use of a rescue medication.
The change in transit time (TT), in hours and minutes, of gastric emptying (GE), small bowel (SB), large bowel (LB) and whole gut (WG) measured by SmartPill in 29 patients with chronic constipation after taking lubiprostone 24 micrograms twice a day (BID) for 2 weeks.
Change in the mean area under the curve of the breath hydrogen and methane gas profiles in parts per million, from time 0 to 120 minutes, between baseline versus mean area under the curve at the end of study.
| Arm | Type | Description |
|---|---|---|
| Lubiprostone | EXPERIMENTAL | 8 mcg capsule twice daily (BID) |
| Placebo | PLACEBO_COMPARATOR | Matching placebo capsule twice daily (BID) |
| Lubiprostone 24 μg | EXPERIMENTAL | Lubiprostone 24 μg, capsules, orally, twice daily, under fed conditions, for 4 weeks. |
| Name | Type | Description |
|---|---|---|
| Lubiprostone | DRUG | - |
| Placebo | DRUG | - |
| Lubiprostone Control | DRUG | Colonic transit study performed and stool/symptom diaries will be reviewed. Eligible subjects will be given a lactulose breath test and randomized to Lubiprostone or placebo. Treatment group receives 24 mcg Lubiprostone twice daily and placebo group receives pills (identical in appearance to the study drug) for one month. Subjects will be asked to maintain a daily stool/symptom diary for duration of the study. In the middle of the study a research coordinator will call the subjects to take questions/concerns and record adverse events. Lactulose breath test will be repeated, constipation questionnaire filled out, colon transit study performed. |
Inclusion Criteria: * 18 years of age and older * Stable fiber therapy * Normal colonoscopy/sigmoidoscopy * Able to refrain from use of medications known to treat or associated with constipation symptoms * Experiences abdominal discomfort/pain associated with bowel movements * Reports decreased bow...
Lubiprostone is a small molecule being studied for gastrointestinal conditions including constipation, chronic constipation, methanogenesis, chronic idiopathic constipation, irritable bowel syndrome, and irritable bowel syndrome with constipation. It is developed by Takeda Pharmaceutical Company Limited and is currently in clinical development.
Lubiprostone is a small molecule that activates chloride channels in the gastrointestinal tract, increasing fluid secretion to soften stool and promote bowel movements. It is being investigated for conditions like chronic idiopathic constipation and irritable bowel syndrome with constipation.
Lubiprostone is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical trials to evaluate the drug for various gastrointestinal conditions.
Lubiprostone is in Phase 1 clinical development for gastrointestinal conditions. It has completed three trials, including Phase 1 and Phase 3 studies, but is not yet approved and remains investigational.
Lubiprostone has completed three clinical trials: NCT01166789, a Phase 1 study on visceral pain sensitivity in irritable bowel syndrome; NCT01190020, a Phase 1 study on methanogenesis and bowel function in chronic constipation; and NCT02651155, a Phase 3 study for chronic idiopathic constipation.
Lubiprostone is also known by the brand name Amitiza. It is being studied for chronic constipation and irritable bowel syndrome with constipation, and is developed by Takeda Pharmaceutical Company Limited.