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A Safety and Efficacy Evaluation of BLI801 Laxative in Constipated Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Braintree Laboratories
ClinicalTrials.gov Identifier:
NCT01687985
First received: September 14, 2012
Last updated: July 14, 2014
Last verified: July 2014

September 14, 2012
July 14, 2014
August 2012
March 2013   (final data collection date for primary outcome measure)
Treatment Success [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
percent of patients experiencing a response in 3 out of 4 weeks of treatment
Same as current
Complete list of historical versions of study NCT01687985 on ClinicalTrials.gov Archive Site
serum chemistry [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Safety and Efficacy Evaluation of BLI801 Laxative in Constipated Adults
A Safety and Efficacy Evaluation of BLI801 Laxative in Constipated Adults

A pilot study to evaluate the safety and efficacy of multiple BLI801 doses in constipated adults.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Constipation
  • Drug: BLI801 laxative - low dose
    BLI801 laxative - oral solution
  • Drug: BLI801 laxative - high dose
    BLI801 laxative - oral solution
    Other Name: BLI801
  • Experimental: BLI801 laxative - low dose
    BLI801 laxative - oral solution
    Intervention: Drug: BLI801 laxative - low dose
  • Experimental: BLI801 laxative - high dose
    BLI801 laxative - oral solution
    Intervention: Drug: BLI801 laxative - high dose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
81
March 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

Male or female subjects at least 18 years of age

Constipated, defined by ROME definition:

Otherwise in good health, as determined by physical exam and medical history

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 currently 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
 
NCT01687985
BLI801-202
No
Braintree Laboratories
Braintree Laboratories
Not Provided
Study Director: John McGowan, MPH Braintree Laboratories, Inc.
Braintree Laboratories
July 2014

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