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A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02481947
First Posted: June 25, 2015
Last Update Posted: January 31, 2017
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.
Information provided by (Responsible Party):
Braintree Laboratories
  Purpose
The purpose of this study is to evaluate a daily dose of BLI400 Laxative for safety and efficacy versus lubiprostone in constipated adults.

Condition Intervention Phase
Chronic Idiopathic Constipation Drug: BLI400 Laxative Drug: Lubiprostone Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults

Resource links provided by NLM:


Further study details as provided by Braintree Laboratories:

Primary Outcome Measures:
  • Complete Spontaneous Bowel Movement (CSBM) [ 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.


Enrollment: 459
Study Start Date: May 2015
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BLI400 Laxative
BLI400 Laxative
Drug: BLI400 Laxative
Oral laxative
Active Comparator: Lubiprostone
Lubiprostone
Drug: Lubiprostone
Oral laxative

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects at least 18 years of age
  • Constipated, defined by the following adapted ROME II definition:

A. 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:

  1. Straining during > 25% of defecations
  2. Lumpy or hard stools in > 25% of defecations
  3. Sensation of incomplete evacuation for > 25% of defecations

B. Loose stools are rarely present without the use of laxatives

C. There are insufficient criteria for IBS - loose (mushy) or watery stool in the absence of laxative use for more than 25% of bowel movements

Criteria A, B and C must be fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.

  • Otherwise in good health, as determined by physical exam and medical history
  • If female, and of child-bearing potential, is using an acceptable form of birth control
  • 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:

  • 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 5
  • 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 study medication 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 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
  • Subjects with known or suspected moderate to severe hepatic insufficiency (Child Pugh Classes B and C)
  Contacts and Locations
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): NCT02481947


  Show 50 Study Locations
Sponsors and Collaborators
Braintree Laboratories
Investigators
Study Director: John McGowan, MPH Braintree Laboratories, Inc.
  More Information

Responsible Party: Braintree Laboratories
ClinicalTrials.gov Identifier: NCT02481947     History of Changes
Other Study ID Numbers: BLI400-301
First Submitted: June 23, 2015
First Posted: June 25, 2015
Last Update Posted: January 31, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Lubiprostone
Laxatives
Cathartics
Chloride Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents