An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
This study has been completed.
Sponsor:
Braintree Laboratories
Information provided by:
Braintree Laboratories
ClinicalTrials.gov Identifier:
NCT00278967
First received: January 13, 2006
Last updated: October 18, 2006
Last verified: October 2006
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Purpose
To compare the safety and efficacy of 2 different bowel cleansing preparations prior to colonoscopy in adult subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Colonoscopy |
Drug: HalfLytely with Bisacodyl Tablets Bowel Prep Kit Drug: HalfLytely - Reformulation |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects |
Resource links provided by NLM:
Further study details as provided by Braintree Laboratories:
Primary Outcome Measures:
- Efficacy - preparation quality using a 4-point scale
Secondary Outcome Measures:
- Safety - patient-reported preparation related side-effects
| Estimated Enrollment: | 450 |
| Study Start Date: | February 2006 |
| Estimated Study Completion Date: | August 2006 |
The goal of the study is to evaluate the efficacy of 2 different HalfLytely preparations to produce a clinically acceptable degree of cleansing of the bowel, sufficient for colonoscopy.
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 the following routinely accepted indications:
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, 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, or toxic megacolon
- Subjects with impaired consciousness that predisposes them to pulmonary aspiration
- Subjects who are undergoing colonoscopy for foreign body removal and decompression
- Subjects with pre-existing electrolyte disturbances, such as dehydration, or those secondary to the use of diuretics
- Subjects who are taking drugs that may affect electrolyte levels
- Subjects taking laxatives or prokinetic agents that refuse to discontinue these treatments for the duration of the study
- Subjects with known clinically significant electrolyte abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia
- 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: NCT00278967
Locations
| United States, California | |
| Anaheim, California, United States, 92801 | |
| United States, Florida | |
| Jupiter, Florida, United States, 33458 | |
| Miami, Florida, United States, 33173 | |
| United States, Louisiana | |
| Baton Rouge, Louisiana, United States, 70809 | |
| United States, Maryland | |
| Laurel, Maryland, United States, 20707 | |
| United States, New York | |
| Great Neck, New York, United States, 11023 | |
| United States, North Carolina | |
| Raleigh, North Carolina, United States, 27612 | |
| United States, Tennessee | |
| Germantown, Tennessee, United States, 38138 | |
| United States, Washington | |
| Bellevue, Washington, United States, 98004 | |
| Spokane, Washington, United States, 99207 | |
Sponsors and Collaborators
Braintree Laboratories
Investigators
| Principal Investigator: | Michael Goldstein, M.D. | Long Island GI Research Group |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00278967 History of Changes |
| Other Study ID Numbers: | F38-26 |
| Study First Received: | January 13, 2006 |
| Last Updated: | October 18, 2006 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Braintree Laboratories:
|
colonoscopy preparation |
Additional relevant MeSH terms:
|
Bisacodyl Cathartics Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013