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

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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

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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