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Phase 4 N=308 Randomized Single-blind Treatment

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

Colonoscopy

Enrolled (actual)
308
Serious AEs
0.3%
Results posted
Sep 2010
Primary outcome: Primary: Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale — 77.6; 80.1 percent of participants — p=0.005

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
PEG electrolyte lavage solution + bisacodyl - reformulation (Drug); PEG electrolyte lavage solution + bisacodyl (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Braintree Laboratories
Primary completion
May 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale
77.6; 80.1 0.005 sig

Summary

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

Eligibility Criteria

Inclusion Criteria

  • Male or female outpatients who are undergoing colonoscopy for a routinely accepted indications:
  • 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
  • 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 with the exception of routine diuretics
  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00857272). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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