Clinical trial NCT00278967: An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
Official title: An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colonoscopy
Keywords: colonoscopy
preparation
Lead sponsor: Braintree Laboratories
Sponsor class: INDUSTRY
First posted: 2006-01-19
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the safety and efficacy of 2 different bowel cleansing preparations prior to colonoscopy in adult subjects.

Detailed description: 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 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

Primary outcomes:
measure: Efficacy - preparation quality using a 4-point scale
Secondary outcomes:
measure: Safety - patient-reported preparation related side-effects
Other outcomes:
Locations:
city: Anaheim
country: United States
state: California
city: Jupiter
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Baton Rouge
country: United States
state: Louisiana
city: Laurel
country: United States
state: Maryland
city: Great Neck
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Germantown
country: United States
state: Tennessee
city: Bellevue
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
Study officials:
affiliation: Long Island GI Research Group
name: Michael Goldstein, M.D.
role: PRINCIPAL_INVESTIGATOR
References: