Approval Probability
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Linaclotide · 1 trial · 1 indication
A 12-week Abdominal Pain/Abdominal Discomfort Responder is a patient who meets the Abdominal Pain/Abdominal Discomfort Weekly Responder criteria (i.e., an improvement of ≥30% from baseline in either the mean abdominal pain score or mean abdominal discomfort score for that week, with neither score worsening from baseline for that week) for at least 6 out of the 12 weeks of the Treatment Period. Abdominal pain at its worst (in the last 24 hours) was assessed daily by patients on an 11-point numerical rating scale (NRS) where 0 represents no abdominal pain and 10 represents very severe abdominal pain. Abdominal discomfort (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal discomfort and 10 represents very severe abdominal discomfort.
A 12-week IBS Degree of Relief Responder is a patient who meets the IBS Degree of Relief Weekly Responder criteria (i.e., response to the degree of relief of IBS symptoms question for that week was "Considerably relieved" or "Completely relieved") for at least 6 out of the 12 weeks of the Treatment Period. Degree of relief of IBS symptoms (in the last 7 days) was assessed weekly by patients on a 7-point balanced ordinal scale where 1 = Completely relieved, 4 = Unchanged, and 7 = As bad as I can imagine.
| Arm | Type | Description |
|---|---|---|
| controlled arm | PLACEBO_COMPARATOR | - |
| treatment arm | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | matching Placebo Capsules, Oral, once daily |
| Linaclotide | DRUG | Linaclotide 290 ug Capsules, Oral, once daily |
Inclusion Criteria: 1. Patient has signed an Informed Consent Form(ICF). 2. Patient Must not be pregnant or breastfeeding and agree to use birth control 3. Patient meets the colonoscopy requirements defined by the American Gastroenterological Association guidelines and no clinically-significant lab...
Linaclotide is an investigational small molecule being developed for the treatment of Irritable Bowel Syndrome With Constipation (IBS-C). It is administered orally and is currently in Phase 3 clinical development. The drug is designed to address the symptoms of IBS-C, a gastrointestinal condition characterized by abdominal pain and constipation.
Linaclotide is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca is conducting clinical trials to evaluate the safety and efficacy of Linaclotide for the treatment of Irritable Bowel Syndrome With Constipation (IBS-C).
Linaclotide is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 3 trial has been completed to assess its efficacy and safety in patients with Irritable Bowel Syndrome With Constipation (IBS-C).
Linaclotide has one completed Phase 3 clinical trial, identified as NCT01880424. This international, multicenter, randomized, double-blind, placebo-controlled trial enrolled 1,722 patients with Irritable Bowel Syndrome With Constipation (IBS-C). The study was conducted in the United States, Australia, Canada, China, and New Zealand, and included adults aged 18 years and older.
Linaclotide is a small molecule that works by targeting the guanylate cyclase-C receptor in the gastrointestinal tract. By activating this receptor, it increases fluid secretion and accelerates intestinal transit, which helps relieve constipation and reduce abdominal pain associated with Irritable Bowel Syndrome With Constipation (IBS-C).