Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lubiprostone · 1 trial · 1 indication
Clinical equivalence of the Test and Reference treatments and the superiority of each active treatment over the Placebo in the change from baseline in mean number of SBM's during the 7 day treatment period of the study
| Arm | Type | Description |
|---|---|---|
| Lubiprostone | EXPERIMENTAL | Manufactured by Dr Reddy's Laboratories Ltd( 24 mcg administered for 7 days ) |
| AMITIZA® | ACTIVE_COMPARATOR | Manufactured by Sucampo Pharmaceuticals(24 mcg administered for 7 days) |
| Placebo | PLACEBO_COMPARATOR | Manufactured by Dr Reddy's Laboratories Ltd ( 24 mcg adminstered for 7 days ) |
| Name | Type | Description |
|---|---|---|
| Lubiprostone | DRUG | 24 mcg Capsules to be given in the experimental arm with Placebo Of AMITIZA |
| Placebo | DRUG | 24 mcg capsules of both experimental Lubiprostone and AMITIZA |
Main Inclusion Criteria: 1. Patients who have signed the written informed consent form prior to entering the study. 2. Male or non-pregnant female aged ≥ 18 years with a clinical diagnosis of CIC defined as, on average, \< 3 SBMs per week and confirmed by daily diary during the two week baseline/wa...
Lubiprostone is used for the treatment of Chronic Idiopathic Constipation. It is a small molecule being developed by Dr. Reddy's Laboratories Ltd. The drug is currently in Phase 3 clinical development for this gastrointestinal condition.
Lubiprostone is a small molecule that activates chloride channels in the intestine, increasing fluid secretion to soften stool and promote bowel movements. It is being studied for Chronic Idiopathic Constipation, a condition characterized by difficult or infrequent bowel movements without an identifiable cause.
Lubiprostone is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker RDY. The company is conducting clinical trials to evaluate the drug for the treatment of Chronic Idiopathic Constipation.
Lubiprostone is in Phase 3 clinical development for Chronic Idiopathic Constipation. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the results will inform potential regulatory submissions.
Lubiprostone has one completed Phase 3 clinical trial, identified as NCT01674530. This trial evaluated the clinical equivalence between two lubiprostone products in the treatment of Chronic Idiopathic Constipation. The study enrolled 909 participants in the United States and was randomized, double-blind, and placebo-controlled.
Lubiprostone is the generic name for the drug, which is also known by the brand name Amitiza. The Phase 3 trial NCT01674530 was designed to evaluate the clinical equivalence between two lubiprostone products, suggesting that Dr. Reddy's is developing a generic version of the drug.