A Pilot Efficacy Evaluation of BLI-801 as a Laxative in Constipated Adults

This study has been completed.
Sponsor:
Information provided by:
Braintree Laboratories
ClinicalTrials.gov Identifier:
NCT00583154
First received: December 20, 2007
Last updated: September 24, 2009
Last verified: September 2009
  Purpose

To compare the safety and efficacy of BLI-801 administered at 4 dose levels in constipated adults.


Condition Intervention Phase
Constipation
Drug: BLI-801
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Efficacy Evaluation of BLI-801 as a Laxative in Constipated Adults

Resource links provided by NLM:


Further study details as provided by Braintree Laboratories:

Primary Outcome Measures:
  • Bowel Movement Count [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: October 2007
Study Completion Date: April 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
BLI-801 Dose 1
Drug: BLI-801
Dose 1
Experimental: 2
BLI-801 Dose 2
Drug: BLI-801
Dose 2
Experimental: 3
BLI-801 Dose 3
Drug: BLI-801
Dose 3
Experimental: 4
BLI-801 Dose 4
Drug: BLI-801
Dose 4

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects at least 18 years of age
  • Constipated according to ROME I criteria
  • 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 (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:

  • Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon
  • Subjects taking laxatives or prokinetic agents that refuse to discontinue these treatments for the duration of the study
  • Subjects who are pregnant or lactating, or intending to become pregnant during the study
  • Subjects of childbearing potential who refuse a pregnancy test
  • Subjects who are allergic to any BLI-801 component.
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00583154

Locations
United States, California
Anaheim, California, United States
United States, Rhode Island
Cranston, Rhode Island, United States
Cumberland, Rhode Island, United States
Sponsors and Collaborators
Braintree Laboratories
Investigators
Study Director: John McGowan Braintree Laboratories, Inc.
  More Information

No publications provided

Responsible Party: John McGowan, Clinical Operations Manager, Braintree Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00583154     History of Changes
Other Study ID Numbers: BLI-801-101
Study First Received: December 20, 2007
Last Updated: September 24, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Braintree Laboratories:
constipation
laxative

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Laxatives
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014