CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 330 enrolled
Drug / intervention
BLI400 Laxativedrug
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Age ≥18 years, male or female
  • ✓Constipation defined by Rome II criteria: ≤3 spontaneous defecations per week PLUS ≥1 of the following for ≥12 weeks in preceding 12 months: straining >25%, hard stools >25%, or incomplete evacuation >25%
  • ✓Female of childbearing potential using acceptable birth control (hormonal, IUD, double-barrier, depot contraceptive, sterilized, abstinent, or vasectomized spouse)
  • ✓Negative urine pregnancy test at screening if applicable
Key exclusion· 13
  • ✕Loose or watery stools >25% of bowel movements in 12 weeks before Visit 1 (without laxatives)
  • ✕Meets Rome II criteria for Irritable Bowel Syndrome
  • ✕Known or suspected ileus, GI obstruction, gastric retention, bowel perforation, toxic colitis, or toxic megacolon
  • ✕Major surgery within 30 days, appendectomy/cholecystectomy within 60 days, abdominal/pelvic/retroperitoneal surgery within 6 months, or prior bariatric surgery or GI tract resection

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02819310
NCT02819310Phase 3Completed
CompareCT.gov

An Open Label Study of Chronic Use of BLI400 Laxative in Constipated Adults

Braintree Laboratories·interventional·Posted Jun 30, 2016·Updated Jul 9, 2020

In Brief

A Phase 3 clinical trial evaluating BLI400 Laxative for Constipation and 2 related conditions. Completed, enrolled 330 participants across 24 sites.

Detailed Summary

The objective of this study is to evaluate the safety of chronic use of BLI400 laxative in constipated adults.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsConstipation, Chronic Idiopathic Constipation, CIC
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 30, 2016
Enrollment StartJun 1, 2016
Primary CompletionAug 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 10.0 years ago

Interventions

BLI400 Laxativedrug

oral laxative