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

NCT ID: NCT02820714

Last Updated: 2018-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2017-01-31

Brief Summary

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

Conditions

Constipation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BLI801 Laxative

BLI801 oral laxative

Group Type: EXPERIMENTAL

BLI801 Laxative

Intervention Type: DRUG

BLI801 Laxative

Interventions

BLI801 Laxative

BLI801 Laxative

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female subjects at least 18 years of age

2. Taking medication known to cause constipation. This medication should remain stable throughout the study.

3. 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

4. Otherwise in good health, as determined by physical exam and medical history

5. If female, and of child-bearing potential, is using an acceptable form of birth control

6. Negative urine pregnancy test at screening (visit 1), if applicable

7. In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Exclusion Criteria

1. Subjects whose constipation diagnosis and symptoms predate the initiation of treatment with the constipating medication.

2. Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon

3. 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

4. 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:

1. Absence of a structural or biochemical explanation for the abdominal pain symptom

2. 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.

5. Subjects taking other prohibited concomitant medications.

6. Subjects who are pregnant or nursing, or intend to become pregnant during the study

7. Subjects of childbearing potential who refuse a pregnancy test

8. Subjects who are allergic to any BLI801 component

9. Active substance or alcohol use that, in the opinion of the investigator, could compromise patient's ability to comply with the study instructions.

10. Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days

11. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.

12. Subjects who withdraw consent at any time prior to completion of Visit 1 procedures

13. Subjects who have had a colonoscopy within 2 weeks of Visit 1 or are scheduled to have a colonoscopy during their participation in the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Braintree Laboratories

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John McGowan

Role: STUDY_DIRECTOR

Braintree Laboratories, Inc.

Locations

Braintree Research Site 1

Mobile, Alabama, United States

Braintree Research Site 3

Bastrop, Louisiana, United States

Braintree Research Site 2

Chattanooga, Tennessee, United States

Countries

United States

Other Identifiers

BLI801-204

Identifier Type: -

Identifier Source: org_study_id