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

Primary Purpose

Constipation, Chronic Idiopathic Constipation, CIC

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
BLI400 Laxative
Sponsored by
Braintree Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 (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

Sites / Locations

  • Braintree Research Site 14
  • Braintree Research Site 13
  • Braintree Research Site 3
  • Braintree Research Site 18
  • Braintree Research Site 19
  • Braintree Research Site 8
  • Braintree Research Site 4
  • Braintree Research Site 5
  • Braintree Research Site 16
  • Braintree Research Site 17
  • Braintree Research Site 12
  • Braintree Research Site 2
  • Braintree Research Site 24
  • Braintree Research Site 15
  • Braintree Research Site 25
  • Braintree Research Site 21
  • Braintree Research Site 6
  • Braintree Research Site 11
  • Braintree Research Site 22
  • Braintree Research Site 10
  • Braintree Research Site 20
  • Braintree Research Site 23
  • Braintree Research Site 1
  • Braintree Research Site 7

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BLI400 Laxative

Arm Description

BLI400 Laxative

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 28, 2016
Last Updated
June 25, 2020
Sponsor
Braintree Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT02819310
Brief Title
An Open Label Study of Chronic Use of BLI400 Laxative in Constipated Adults
Official Title
An Open Label Study of Chronic Use of BLI400 Laxative in Constipated Adults
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Braintree Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation, Chronic Idiopathic Constipation, CIC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
330 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BLI400 Laxative
Arm Type
Experimental
Arm Description
BLI400 Laxative
Intervention Type
Drug
Intervention Name(s)
BLI400 Laxative
Intervention Description
oral laxative
Primary Outcome Measure Information:
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subjects at least 18 years of age 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 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) Negative urine pregnancy test at screening, if applicable In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study Exclusion Criteria: 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 Meet the Rome II criteria for Irritable Bowel Syndrome Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon 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 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 Subjects taking laxatives, enemas or prokinetic agents that refuse to discontinue these treatments from Visit 1 until after completion of Visit 6 Subjects who are pregnant or lactating, or intend to become pregnant during the study Subjects of childbearing potential who refuse a pregnancy test Subjects who are allergic to any BLI400 component Subjects taking narcotic analgesics or other medications known to cause constipation. Subjects with clinically significant cardiac abnormalities identified at the Visit 1 ECG Subjects with clinically significant laboratory abnormalities, deemed as a potential safety issue by the Investigator, may be discontinued at the Investigator's discretion. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days Subjects with an active history of drug or alcohol abuse Subjects have been hospitalized for a psychiatric condition or have made a suicide attempt during the 2 years before Visit 1 Subjects who withdraw consent at any time prior to completion of Visit 1 procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John McGowan
Organizational Affiliation
Braintree Laboratories, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Braintree Research Site 14
City
Corona
State/Province
California
ZIP/Postal Code
92879
Country
United States
Facility Name
Braintree Research Site 13
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Braintree Research Site 3
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Braintree Research Site 18
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Braintree Research Site 19
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Braintree Research Site 8
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Braintree Research Site 4
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Braintree Research Site 5
City
Miami
State/Province
Florida
ZIP/Postal Code
33142
Country
United States
Facility Name
Braintree Research Site 16
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Braintree Research Site 17
City
Palmetto Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
Braintree Research Site 12
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Braintree Research Site 2
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Braintree Research Site 24
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
Braintree Research Site 15
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Braintree Research Site 25
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89103
Country
United States
Facility Name
Braintree Research Site 21
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28314
Country
United States
Facility Name
Braintree Research Site 6
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45224
Country
United States
Facility Name
Braintree Research Site 11
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Braintree Research Site 22
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Braintree Research Site 10
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
Facility Name
Braintree Research Site 20
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75010
Country
United States
Facility Name
Braintree Research Site 23
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Facility Name
Braintree Research Site 1
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Braintree Research Site 7
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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