Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01674530 | Evaluation of Clinical Equivalence Between Two Lubiprostone Products in the Treatment of Chronic Idiopathic Constipation | PHASE3 | COMPLETED | 909 | — | — | Oct 1, 2012 | Mar 1, 2014 | Apr 3, 2014 | 93 | United States |
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...