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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02819297
Recruitment Status : Completed
First Posted : June 30, 2016
Results First Posted : June 26, 2020
Last Update Posted : July 27, 2020
Sponsor:
Information provided by (Responsible Party):
Braintree Laboratories

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

Condition or disease Intervention/treatment Phase
Constipation Chronic Idiopathic Constipation CIC Drug: BLI400 Laxative Drug: BLI400 Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1020 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : June 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arms and Interventions
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Arm Intervention/treatment
Experimental: BLI400 Laxative
BLI400 Laxative
 Drug: BLI400 Laxative
21 gm BLI400 powder
Placebo Comparator: Placebo
BLI400 placebo
 Drug: BLI400 Placebo
Equivalent amount of placebo powder


Outcome Measures
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Primary Outcome Measures :
  1. Treatment Response [ Time Frame: 12 weeks ]
    The primary endpoint is the proportion of subjects who are weekly responders for at least 9 out of 12 weeks, with at least 3 of these weeks occurring in the last 4 weeks of treatment. A weekly responder is a subject who has ≥ 3 CSBMs and an increase from baseline of > 1 CSBM in that week.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02819297


Locations
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Sponsors and Collaborators
Braintree Laboratories
Investigators
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Study Director: John McGowan Braintree Laboratories, Inc.
  Study Documents (Full-Text)

Documents provided by Braintree Laboratories:
Study Protocol and Statistical Analysis Plan  [PDF] April 13, 2016

More Information
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Responsible Party: Braintree Laboratories
ClinicalTrials.gov Identifier: NCT02819297    
Other Study ID Numbers: BLI400-302
First Posted: June 30, 2016    Key Record Dates
Results First Posted: June 26, 2020
Last Update Posted: July 27, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Laxatives
Gastrointestinal Agents