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Label indication Lubiprostone is a chloride channel activator indicated for the treatment of: chronic idiopathic constipation (CIC) in adults. ( 1.1 ) opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. FDA label
Also known as Amitiza
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 used to treat chronic constipation, including chronic idiopathic constipation, and irritable bowel syndrome with constipation. It is also studied in methanogenesis. It is a small molecule developed by Takeda Pharmaceutical Company Limited for gastrointestinal conditions.
Lubiprostone targets CLCN2, a chloride channel, and acts as an opener of this channel. By opening CLCN2, it increases chloride-rich fluid secretion into the intestinal lumen, which supports intestinal motility and stool passage in constipation-related conditions.
Lubiprostone is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the company associated with the clinical development program for lubiprostone across chronic constipation and irritable bowel syndrome with constipation indications.
Lubiprostone is in Phase 1 development according to the current program data, and it is investigational rather than approved. The clinical program includes completed Phase 3 trials in chronic idiopathic constipation, with three total trials recorded and no active trials at this time.
Lubiprostone has been studied in completed trials including NCT02729909 in Mexico, NCT02695719 in South Korea, NCT02651155 in Russia, and NCT01993875 in the United States. These trials enrolled adults with chronic idiopathic constipation or constipation, with total enrollment of 590 participants.
Yes, lubiprostone is also known as Cohort 1: Lubiprostone Capsule, Fasted and Cohort 1: Lubiprostone, Fasted. These names refer to the same small molecule studied in clinical trials for chronic constipation and related gastrointestinal conditions.