BLI801 Laxative in Constipated Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Braintree Laboratories
ClinicalTrials.gov Identifier:
NCT01301781
First received: February 22, 2011
Last updated: September 27, 2012
Last verified: September 2012

February 22, 2011
September 27, 2012
January 2011
May 2011   (final data collection date for primary outcome measure)
percentage of patients experiencing a bowel movement within 3 hours of the first study medication dose [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01301781 on ClinicalTrials.gov Archive Site
  • percentage of patients experiencing a complete/satisfactory bowel movement (BM) within 3 hours of first dose [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
  • serum chemistry [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
BLI801 Laxative in Constipated Adults
A Pilot Efficacy Evaluation of BLI801 Laxative in Constipated Adults

A pilot study to evaluate the safety and efficacy of BLI801 vs. placebo in constipated adults.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Constipation
  • Drug: BLI801
    BLI801 laxative - oral solution
  • Drug: Placebo
    BLI801 placebo - oral solution
  • Experimental: BLI801 laxative
    BLI801 laxative - oral solution
    Intervention: Drug: BLI801
  • Placebo Comparator: Placebo
    BLI801 placebo - oral solution
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
Not Provided
May 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Constipated, defined by ROME III definition
  • Subject has < 3 satisfactory BMs during the run-in period

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.
  • Subjects who are allergic to any BLI801 component
  • Subjects taking narcotic analgesics or other medications known to cause constipation.
  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01301781
BLI801-201
No
Braintree Laboratories
Braintree Laboratories
Not Provided
Not Provided
Braintree Laboratories
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP