F38-27: An Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects

Braintree Laboratories

Status and phase: Completed; Phase 4

Conditions: Colonoscopy

Treatments: Drug: PEG electrolyte lavage solution + bisacodyl; Drug: PEG electrolyte lavage solution + bisacodyl - reformulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT00857272

F38-27

Details and patient eligibility

About

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

Enrollment: 308 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female outpatients who are undergoing colonoscopy for a routinely accepted indications:
2. At least 18 years of age
3. Otherwise in good health, as determined by physical exam and medical history
4. If female, and of child-bearing potential, is using an acceptable form of birth control
5. Negative urine pregnancy test at screening, if applicable
6. In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Exclusion criteria

1. Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or toxic megacolon
2. Subjects with impaired consciousness that predisposes them to pulmonary aspiration
3. Subjects who are undergoing colonoscopy for foreign body removal and decompression
4. Subjects with pre-existing electrolyte disturbances, such as dehydration, or those secondary to the use of diuretics
5. Subjects who are taking drugs that may affect electrolyte levels with the exception of routine diuretics
6. Subjects with known clinically significant electrolyte abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia
7. Subjects who are pregnant or lactating, or intending to become pregnant during the study
8. Subjects of childbearing potential who refuse a pregnancy test
9. Subjects who are allergic to any preparation components
10. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures
11. Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

308 participants in 2 patient groups

HalfLytely with 10mg bisacodyl

Active Comparator group

Description:

Active control

Treatment:

Drug: PEG electrolyte lavage solution + bisacodyl

HalfLytely with 5mg bisacodyl

Experimental group

Description:

Investigational dose

Treatment:

Drug: PEG electrolyte lavage solution + bisacodyl - reformulation