A Safety and Efficacy Evaluation of BLI801 Laxative in Adults Experiencing Non-Idiopathic Constipation
NCT02822508 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 434
Last updated 2023-11-07
Summary
The objective of this study is to evaluate multiple doses of BLI801 Laxative for safety and efficacy versus placebo in adults experiencing non-idiopathic constipation.
Conditions
Interventions
- DRUG
-
BLI801 Laxative
BLI801 oral laxative
- DRUG
-
BLI801 Placebo
BLI801 oral laxative placebo
Sponsors & Collaborators
-
Braintree Laboratories
lead INDUSTRY
Principal Investigators
-
John McGowan · Braintree Laboratories, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 84 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-06-30
- Primary Completion
- 2017-04-30
- Completion
- 2017-04-30
Countries
- United States
Study Locations
More Related Trials
-
An Open Label Study of Chronic Use of BLI400 Laxative in Constipated Adults
NCT02819310 ·Status: COMPLETED ·Phase: PHASE3
-
A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults
NCT02481947 ·Status: COMPLETED ·Phase: PHASE3
-
A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adolescent Subjects
NCT02665728 ·Status: COMPLETED ·Phase: PHASE2
-
BLI800-303: An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
NCT00856843 ·Status: COMPLETED ·Phase: PHASE3
-
A Safety and Efficacy Comparison of BLI4700 Bowel Preparation Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy
NCT03261960 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy, Safety and Tolerability of a Bowel Cleansing Preparation (BLI800) in Pediatric Subjects Undergoing Colonoscopy
NCT02189850 ·Status: COMPLETED ·Phase: PHASE2
-
BLI-800-301: BLI-800 vs an Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy
NCT00503607 ·Status: COMPLETED ·Phase: PHASE3
-
A Pilot Evaluation of BLI4900 Bowel Preparation in Adult Subjects
NCT03328507 ·Status: COMPLETED ·Phase: PHASE2
-
Extended Use of Polyethyleneglycol3350 Laxative in Constipated Patients
NCT00153153 ·Status: COMPLETED ·Phase: PHASE4
-
BLI-800-302: BLI-800 vs an Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy
NCT00503815 ·Status: COMPLETED ·Phase: PHASE3
-
A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects
NCT03023085 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
An Open Label Study of Chronic Polyethyleneglycol3350 Use in Constipated Patients
NCT00164125 ·Status: COMPLETED ·Phase: PHASE4
-
Study 302: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy
NCT04446312 ·Status: COMPLETED ·Phase: PHASE3
-
Phase 2 Study to Evaluate Safety and Efficacy of RM-131 Administered to Patients With Chronic Constipation
NCT01781104 ·Status: COMPLETED ·Phase: PHASE2
-
BLI4700-202: A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects
NCT03103581 ·Status: COMPLETED ·Phase: PHASE2
-
An Efficacy and Safety Study of Plecanatide in Adolescents 12 to <18 Years of Age With Chronic Idiopathic Constipation
NCT03120520 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate the Effects of RM-131 in Patients With Chronic Constipation
NCT02137642 ·Status: COMPLETED ·Phase: PHASE1
-
Comparison of PolyethyleneGlycol and Placebo for Relief of Constipation From Constipating Medications
NCT00153127 ·Status: COMPLETED ·Phase: PHASE4
-
A Safety and Efficacy Comparison of BLI4700 Bowel Prep Versus an FDA-approved Comparator in Adults Prior to Colonoscopy
NCT03404401 ·Status: COMPLETED ·Phase: PHASE3
-
Study 301: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy
NCT04446299 ·Status: COMPLETED ·Phase: PHASE3
-
Dulcolax vs Placebo in Functional Constipation
NCT00526097 ·Status: COMPLETED ·Phase: PHASE3
-
12-Week Study of Plecanatide for CIC (The CIC3 Study)
NCT01982240 ·Status: COMPLETED ·Phase: PHASE3
-
Comparison of Lubiprostone and Placebo for the Relief of Constipation From Constipating Medications
NCT01096290 ·Status: TERMINATED ·Phase: PHASE4
-
The Plecanatide Chronic Idiopathic Constipation (CIC) Study
NCT01429987 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
A Pilot Evaluation of an Experimental BLI4600 Formulation for Bowel Preparation in Adult Patients Undergoing Colonoscopy
NCT02376465 ·Status: COMPLETED ·Phase: PHASE2