|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT01301781 |
|
Date of registration:
|
22/02/2011 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
BLI801 Laxative in Constipated Adults
|
|
Scientific title:
|
A Pilot Efficacy Evaluation of BLI801 Laxative in Constipated Adults |
|
Date of first enrolment:
|
January 2011 |
|
Target sample size:
|
52 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT01301781 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Key inclusion & exclusion criteria
|
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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Constipation
|
|
Intervention(s)
|
|
Drug: BLI801
|
|
Drug: Placebo
|
|
Primary Outcome(s)
|
|
percentage of patients experiencing a bowel movement within 3 hours of the first study medication dose
[Time Frame: 3 hours]
|
|
Secondary Outcome(s)
|
|
percentage of patients experiencing a complete/satisfactory bowel movement (BM) within 3 hours of first dose
[Time Frame: 3 hours]
|
|
serum chemistry
[Time Frame: 7 days]
|
|
Secondary ID(s)
|
|
BLI801-201
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|