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

NCT ID: NCT02819310

Last Updated: 2020-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2017-08-31

Brief Summary

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

Conditions

Constipation; Chronic Idiopathic Constipation; CIC

Study Design

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

Study Groups

BLI400 Laxative

BLI400 Laxative

Group Type: EXPERIMENTAL

BLI400 Laxative

Intervention Type: DRUG

oral laxative

Interventions

BLI400 Laxative

oral laxative

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

2. Constipated, defined by the following adapted ROME II definition:

• Fewer than 3 spontaneous defecations per week and at least one of the following symptoms for at least 12 weeks (which need not be consecutive) in the preceding 12 months:
• Straining during > 25% of defecations
• Lumpy or hard stools in > 25% of defecations
• Sensation of incomplete evacuation for > 25% of defecations

3. If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, IUD, double-barrier method, depot contraceptive, sterilized, abstinent, or vasectomized spouse)

4. Negative urine pregnancy test at screening, if applicable

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

Exclusion Criteria

1. Report loose (mushy) or water stools in the absence of laxative use for more than 25% of BMs during the 12 weeks before Visit 1

2. Meet the Rome II criteria for Irritable Bowel Syndrome

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

4. 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

5. Subjects with hypothyroidism that is being treated and for which the dose of thyroid hormone has not been stable for at least 6 weeks at the time of Visit 1

6. Subjects taking laxatives, enemas or prokinetic agents that refuse to discontinue these treatments from Visit 1 until after completion of Visit 6

7. Subjects who are pregnant or lactating, or intend to become pregnant during the study

8. Subjects of childbearing potential who refuse a pregnancy test

9. Subjects who are allergic to any BLI400 component

10. Subjects taking narcotic analgesics or other medications known to cause constipation.

11. Subjects with clinically significant cardiac abnormalities identified at the Visit 1 ECG

12. Subjects with clinically significant laboratory abnormalities, deemed as a potential safety issue by the Investigator, may be discontinued at the Investigator's discretion.

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

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

15. Subjects with an active history of drug or alcohol abuse

16. Subjects have been hospitalized for a psychiatric condition or have made a suicide attempt during the 2 years before Visit 1

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

• 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 14

Corona, California, United States

Braintree Research Site 13

Brandon, Florida, United States

Braintree Research Site 3

Brandon, Florida, United States

Braintree Research Site 18

Hialeah, Florida, United States

Braintree Research Site 19

Hialeah, Florida, United States

Braintree Research Site 4

Miami, Florida, United States

Braintree Research Site 5

Miami, Florida, United States

Braintree Research Site 16

Miami, Florida, United States

Braintree Research Site 8

Miami Lakes, Florida, United States

Braintree Research Site 17

Palmetto Bay, Florida, United States

Braintree Research Site 12

St. Petersburg, Florida, United States

Braintree Research Site 2

West Palm Beach, Florida, United States

Braintree Research Site 24

Owensboro, Kentucky, United States

Braintree Research Site 15

Lake Charles, Louisiana, United States

Braintree Research Site 25

Las Vegas, Nevada, United States

Braintree Research Site 21

Fayetteville, North Carolina, United States

Braintree Research Site 6

Cincinnati, Ohio, United States

Braintree Research Site 11

Chattanooga, Tennessee, United States

Braintree Research Site 22

Memphis, Tennessee, United States

Braintree Research Site 10

Nashville, Tennessee, United States

Braintree Research Site 20

Carrollton, Texas, United States

Braintree Research Site 23

Houston, Texas, United States

Braintree Research Site 1

Plano, Texas, United States

Braintree Research Site 7

Newport News, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

BLI400-303

Identifier Type: -

Identifier Source: org_study_id