Constipation Clinical Trial
Official title:
A Pilot Efficacy Evaluation of BLI-801 as a Laxative in Constipated Adults
Verified date | September 2009 |
Source | Braintree Laboratories |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
To compare the safety and efficacy of BLI-801 administered at 4 dose levels in constipated adults.
Status | Completed |
Enrollment | 60 |
Est. completion date | April 2008 |
Est. primary completion date | January 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Braintree Laboratories |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bowel Movement Count | 24 hours | No | |
Secondary | Adverse events | 24 hours | Yes |
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