BLI400-302: A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults

Braintree Laboratories

Status and phase: Completed; Phase 3

Conditions: Chronic Idiopathic Constipation; CIC; Constipation

Treatments: Drug: BLI400 Placebo; Drug: BLI400 Laxative

Study type: Interventional

Funder types: Industry

Identifiers

NCT02819297

BLI400-302

Details and patient eligibility

About

The objective of this study is to evaluate a daily dose of BLI400 Laxative for safety and efficacy versus placebo in constipated adults.

Enrollment: 1,020 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

4. Negative serum 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 the study
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 study medication 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
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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,020 participants in 2 patient groups, including a placebo group

BLI400 Laxative

Experimental group

Description:

BLI400 Laxative

Treatment:

Drug: BLI400 Laxative

Placebo

Placebo Comparator group

Description:

BLI400 placebo

Treatment:

Drug: BLI400 Placebo