An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects

Colonoscopy Clinical Trial

Official title:

An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00278967
• Other study ID #: F38-26
• Status: Completed
• Phase: Phase 4
• First received: January 13, 2006
• Last updated: October 18, 2006
• Start date: February 2006
• Est. completion date: August 2006

Study information

• Verified date: October 2006
• Source: Braintree Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Drug:
• HalfLytely with Bisacodyl Tablets Bowel Prep Kit

• HalfLytely - Reformulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Braintree Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy - preparation quality using a 4-point scale
Secondary	Safety - patient-reported preparation related side-effects