CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,020 enrolled
Drug / intervention
BLI400 Laxative +1 moredrug
Likely dose
BLI400 21 gm powder orallyAI-extracted
Key inclusion· 4
  • ✓Age ≥18 years, any gender
  • ✓Constipation per Rome II criteria: <3 spontaneous bowel movements per week AND ≥1 symptom (straining >25%, hard stools >25%, or incomplete evacuation >25%) for ≥12 weeks in preceding 12 months
  • ✓Females of childbearing potential using acceptable birth control
  • ✓Mentally competent to provide informed consent
Key exclusion· 11
  • ✕Loose or watery stools >25% of bowel movements in 12 weeks before Visit 1 without laxative use
  • ✕Meets Rome II criteria for Irritable Bowel Syndrome
  • ✕Known or suspected ileus, GI obstruction, gastric retention, bowel perforation, toxic colitis, or toxic megacolon
  • ✕Major GI surgery history (abdominal/pelvic/retroperitoneal surgery <6 months, appendectomy/cholecystectomy <60 days, major surgery <30 days, or any bariatric/GI resection)

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

Search/NCT02819297
NCT02819297Phase 3Completed
CompareCT.gov

BLI400-302: A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults

Braintree Laboratories·interventional·Posted Jun 30, 2016·Updated Jul 27, 2020

In Brief

A Phase 3 clinical trial evaluating BLI400 Laxative and BLI400 Placebo for Constipation and 2 related conditions. Completed, enrolled 1,020 participants across 51 sites.

Detailed Summary

The objective of this study is to evaluate a daily dose of BLI400 Laxative for safety and efficacy versus placebo 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 CompletionJun 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 10.0 years ago

Interventions

BLI400 Laxativedrug

21 gm BLI400 powder

BLI400 Placebodrug

Equivalent amount of placebo powder