A Pilot Study of BLI801 Laxative in Adults Experiencing Non-Idiopathic Constipation

NCT02820714 | Completed Phase 2

• 1 other identifier: BLI801-204
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 3

Brief Summary

The objective of this study is to evaluate BLI801 laxative in adults experiencing non-idiopathic constipation.

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

• % of subjects with treatment response

  Greater than or equal to 3 spontaneous bowel movements per week for 2 out of 4 weeks

  4 weeks

Secondary Outcomes (1)

• % of subjects with treatment emergent adverse events

  4 weeks

Study Arms (1)

BLI801 Laxative

EXPERIMENTAL

BLI801 oral laxative

Drug: BLI801 Laxative

Interventions

BLI801 Laxative DRUG

BLI801 Laxative

BLI801 Laxative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects at least 18 years of age
• Taking medication known to cause constipation. This medication should remain stable throughout the study.
• Constipated, defined by the following criteria: Fewer than 3 spontaneous defecations per week and at least one of the following symptoms for the previous 4 weeks:
• Straining during \> 25% of defecations
• Lumpy or hard stools in \> 25% of defecations
• Sensation of incomplete evacuation for \> 25% of defecations
• Onset of constipation must coincide with the instruction of treatment with a constipating medication
• Otherwise in good health, as determined by physical exam and medical history
• If female, and of child-bearing potential, is using an acceptable form of birth control
• Negative urine pregnancy test at screening (visit 1), if applicable
• In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

You may not qualify if:

• Subjects whose constipation diagnosis and symptoms predate the initiation of treatment with the constipating medication.
• Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon
• Subjects who have had major surgery 30 days before Visit 1; appendectomy or cholecystectomy 60 days before Visit 1; abdominal, pelvic, or retroperitoneal surgery 6 months before Visit 1; bariatric surgery or surgery to remove a segment of the GI tract at any time before Visit 1
• Medical conditions associated with diarrhea, intermittent loose stools, or constipation, which could confound the interpretation of the results, eg, fecal incontinence or irritable bowel syndrome. Subjects with irritable bowel syndrome (IBS) that has been previously diagnosed by a physician prior to initiation of the constipating therapy and that meets the following criteria, are excluded:
• Absence of a structural or biochemical explanation for the abdominal pain symptom
• At least 12 weeks during a period of 12 months, of abdominal discomfort or pain with at least 2 of the following 3 features:
• Relieved with defecation, and/or
• Onset associated with a change in frequency of stool, and/or
• Onset associated with a change in form of stool.
• Subjects taking other prohibited concomitant medications.
• Subjects who are pregnant or nursing, or intend to become pregnant during the study
• Subjects of childbearing potential who refuse a pregnancy test
• Subjects who are allergic to any BLI801 component
• Active substance or alcohol use that, in the opinion of the investigator, could compromise patient's ability to comply with the study instructions.
• Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days

Sponsors & Collaborators

• Braintree Laboratories: lead

Study Sites (3)

Braintree Research Site 1

Mobile, Alabama, 36688, United States

Location

Braintree Research Site 3

Bastrop, Louisiana, 71220, United States

Location

Braintree Research Site 2

Chattanooga, Tennessee, 37421, United States

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• John McGowan

  Braintree Laboratories, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: July 1, 2016
• Study Start: February 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: September 28, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)