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

• Sponsor: Braintree Laboratories (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02819310
• Collaborator: (none)
• Enrollment: 330
• Locations: 24
• Arm: 1
• Actual Duration (Months): 14
• Patients Per Site: 13.8
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Constipation; Chronic Idiopathic Constipation; CIC	Drug: BLI400 Laxative	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 330 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open Label Study of Chronic Use of BLI400 Laxative in Constipated Adults
• Actual Study Start Date: Jun 1, 2016
• Actual Primary Completion Date: Aug 1, 2017
• Actual Study Completion Date: Aug 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BLI400 Laxative BLI400 Laxative	Drug: BLI400 Laxative; oral laxative

Outcome Measures

Primary Outcome Measures

1. % of Subjects With Treatment Emergent Adverse Events [12 months]

   % of subjects experiencing a treatment emergent adverse event during the 12 month treatment period

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. 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)

2. Negative urine pregnancy test at screening, if applicable

3. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Braintree Research Site 14	Corona	California	United States	92879
2	Braintree Research Site 13	Brandon	Florida	United States	33511
3	Braintree Research Site 3	Brandon	Florida	United States	33511
4	Braintree Research Site 18	Hialeah	Florida	United States	33012
5	Braintree Research Site 19	Hialeah	Florida	United States	33012
6	Braintree Research Site 8	Miami Lakes	Florida	United States	33016
7	Braintree Research Site 4	Miami	Florida	United States	33135
8	Braintree Research Site 5	Miami	Florida	United States	33142
9	Braintree Research Site 16	Miami	Florida	United States	33173
10	Braintree Research Site 17	Palmetto Bay	Florida	United States	33157
11	Braintree Research Site 12	Saint Petersburg	Florida	United States	33709
12	Braintree Research Site 2	West Palm Beach	Florida	United States	33409
13	Braintree Research Site 24	Owensboro	Kentucky	United States	42303
14	Braintree Research Site 15	Lake Charles	Louisiana	United States	70601
15	Braintree Research Site 25	Las Vegas	Nevada	United States	89103
16	Braintree Research Site 21	Fayetteville	North Carolina	United States	28314
17	Braintree Research Site 6	Cincinnati	Ohio	United States	45224
18	Braintree Research Site 11	Chattanooga	Tennessee	United States	37421
19	Braintree Research Site 22	Memphis	Tennessee	United States	38119
20	Braintree Research Site 10	Nashville	Tennessee	United States	37211
21	Braintree Research Site 20	Carrollton	Texas	United States	75010
22	Braintree Research Site 23	Houston	Texas	United States	77099
23	Braintree Research Site 1	Plano	Texas	United States	75093
24	Braintree Research Site 7	Newport News	Virginia	United States	23606

Sponsors and Collaborators

• Braintree Laboratories

Investigators

• Study Director: John McGowan, Braintree Laboratories, Inc.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 13, 2016

More Information

Publications

None provided.

• Responsible Party: Braintree Laboratories
• ClinicalTrials.gov Identifier: NCT02819310
• Other Study ID Numbers: BLI400-303
• First Posted: Jun 30, 2016
• Last Update Posted: Jul 9, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Constipation; Laxatives

Study Results

Participant Flow

Arm/Group Title	BLI400 Laxative
Arm/Group Description	BLI400 Laxative BLI400 Laxative: oral laxative
Period Title: Overall Study
STARTED	330
COMPLETED	221
NOT COMPLETED	109

Baseline Characteristics

Arm/Group Title	BLI400 Laxative
Arm/Group Description	BLI400 Laxative BLI400 Laxative: oral laxative
Overall Participants	305
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.5 (16.0)
Sex: Female, Male (Count of Participants)
Female	223 73.1%
Male	82 26.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	133 43.6%
Not Hispanic or Latino	172 56.4%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.3%
Asian	3 1%
Native Hawaiian or Other Pacific Islander	2 0.7%
Black or African American	91 29.8%
White	205 67.2%
More than one race	0 0%
Unknown or Not Reported	3 1%
Region of Enrollment (participants) [Number]
United States	305 100%

Outcome Measures

1. Primary Outcome

Title	% of Subjects With Treatment Emergent Adverse Events
Description	% of subjects experiencing a treatment emergent adverse event during the 12 month treatment period
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

FDA agreed upon Safety Population

Arm/Group Title	BLI400 Laxative
Arm/Group Description	BLI400 Laxative BLI400 Laxative: oral laxative
Measure Participants	305
Count of Participants [Participants]	108 35.4%

Adverse Events

Time Frame	12 months
Arm/Group Title	BLI400 Laxative
Arm/Group Description	BLI400 Laxative BLI400 Laxative: oral laxative
All Cause Mortality
	BLI400 Laxative
	Affected / at Risk (%)	# Events
Total	0/305 (0%)
Serious Adverse Events
	BLI400 Laxative
	Affected / at Risk (%)	# Events
Total	2/305 (0.7%)
Hepatobiliary disorders
Cirrhosis alcoholic	1/305 (0.3%)
Musculoskeletal and connective tissue disorders
Spondylolisthesis	1/305 (0.3%)	305
Other (Not Including Serious) Adverse Events
	BLI400 Laxative
	Affected / at Risk (%)	# Events
Total	34/305 (11.1%)
Gastrointestinal disorders
Diarrhea	23/305 (7.5%)	23
Flatulence	16/305 (5.2%)	16

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The sole disclosure restriction which sponsor imposes on the PI is a sixty (60) day limited restriction in order to the protect potentially proprietary information which may be patentable