BLI-800-302: BLI-800 vs an Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy
This study has been completed.
Sponsor:
Braintree Laboratories
Information provided by:
Braintree Laboratories
ClinicalTrials.gov Identifier:
NCT00503815
First received: July 17, 2007
Last updated: December 20, 2007
Last verified: December 2007
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Purpose
This is a randomized, parallel, multi-center, single-blind study, comparing BLI-800 to an FDA approved bowel preparation in adult subjects undergoing colonoscopy.
| Condition | Intervention | Phase |
|---|---|---|
|
Colonoscopy |
Drug: BLI-800 Drug: Polyethylene glycol 3350 based bowel preparation |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind |
| Official Title: | A Safety and Efficacy Evaluation of BLI-800 vs an Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy |
Resource links provided by NLM:
Further study details as provided by Braintree Laboratories:
Primary Outcome Measures:
- Efficacy - preparation quality using a 4 point scale [ Time Frame: 2-Day ]
Secondary Outcome Measures:
- Safety-preparation related side effects; laboratory analysis [ Time Frame: 30-Day ]
| Estimated Enrollment: | 360 |
| Study Start Date: | July 2007 |
| Study Completion Date: | November 2007 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
-Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication, including:
Evaluation of BE results GI bleeding Anemia of unknown etiology Neoplastic disease surveillance Endosonography Inflammatory bowel disease Unknown diarrhea or constipation etiology Polypectomy Laser therapy Routine Screening
- At least 18 years of age
- 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, 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, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or megacolon.
- Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
- Subjects who are undergoing colonoscopy for foreign body removal and decompression.
- Subjects with clinically significant electrolyte abnormalities based on Visit 1 laboratory results, such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalemia, hypocalcemia, dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors.
- Subjects with a history of renal or hepatic insufficiency or congestive heart failure.
- Subjects who had previous gastrointestinal surgeries
- 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 preparation components
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00503815
Locations
| United States, California | |
| Anaheim, California, United States, 92801 | |
| Orange, California, United States, 92869 | |
| United States, Mississippi | |
| Jackson, Mississippi, United States, 39202 | |
| United States, Oregon | |
| Portland, Oregon, United States, 97210 | |
| United States, Tennessee | |
| Franklin, Tennessee, United States, 37067 | |
| Germantown, Tennessee, United States, 38138 | |
| Jackson, Tennessee, United States | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Houston, Texas, United States, 77090 | |
| United States, Washington | |
| Bellevue, Washington, United States, 98004 | |
Sponsors and Collaborators
Braintree Laboratories
Investigators
| Study Director: | John D McGowan, B.S. | Braintree Laboratories, Inc. |
More Information
No publications provided
| Responsible Party: | John McGowan, Clinical Operations Manager, Braintree Laboratories, Inc. |
| ClinicalTrials.gov Identifier: | NCT00503815 History of Changes |
| Other Study ID Numbers: | BLI-800-302 |
| Study First Received: | July 17, 2007 |
| Last Updated: | December 20, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Braintree Laboratories:
|
colonoscopy bowel preparation prep |
ClinicalTrials.gov processed this record on May 16, 2013