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

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02819310
• Other study ID #: BLI400-303
• Status: Completed
• Phase: Phase 3
• Start date: June 2016
• Est. completion date: August 2017

Study information

• Verified date: June 2020
• Source: Braintree Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Idiopathic Constipation
• CIC
• Constipation

Intervention

Drug:
• BLI400 Laxative
oral laxative

Locations

Country	Name	City	State
United States	Braintree Research Site 13	Brandon	Florida
United States	Braintree Research Site 3	Brandon	Florida
United States	Braintree Research Site 20	Carrollton	Texas
United States	Braintree Research Site 11	Chattanooga	Tennessee
United States	Braintree Research Site 6	Cincinnati	Ohio
United States	Braintree Research Site 14	Corona	California
United States	Braintree Research Site 21	Fayetteville	North Carolina
United States	Braintree Research Site 18	Hialeah	Florida
United States	Braintree Research Site 19	Hialeah	Florida
United States	Braintree Research Site 23	Houston	Texas
United States	Braintree Research Site 15	Lake Charles	Louisiana
United States	Braintree Research Site 25	Las Vegas	Nevada
United States	Braintree Research Site 22	Memphis	Tennessee
United States	Braintree Research Site 16	Miami	Florida
United States	Braintree Research Site 4	Miami	Florida
United States	Braintree Research Site 5	Miami	Florida
United States	Braintree Research Site 8	Miami Lakes	Florida
United States	Braintree Research Site 10	Nashville	Tennessee
United States	Braintree Research Site 7	Newport News	Virginia
United States	Braintree Research Site 24	Owensboro	Kentucky
United States	Braintree Research Site 17	Palmetto Bay	Florida
United States	Braintree Research Site 1	Plano	Texas
United States	Braintree Research Site 12	Saint Petersburg	Florida
United States	Braintree Research Site 2	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Braintree Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% of Subjects With Treatment Emergent Adverse Events	% of subjects experiencing a treatment emergent adverse event during the 12 month treatment period	12 months