ClinicalTrials.Veeva

Menu

Comparison of PolyethyleneGlycol and Placebo for Relief of Constipation From Constipating Medications

Braintree Laboratories logo

Braintree Laboratories

Status and phase

Completed
Phase 4

Conditions

Constipation

Treatments

Drug: polyethyleneglycol3350

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

The purpose of this study is to assess treatment responses comparing a newly FDA-approved PEG laxative versus placebo.

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult male or female ambulatory outpatient age 19 or older.
  • Patients meet ROME II Criteria
  • Patients not meeting ROME IBS criteria
  • Use of a constipating medication (>= 3% in PDR)
  • If female and of childbearing potential, patient must be surgically sterilized or using oral contraceptives, depot contraceptives, intrauterine device, or testifies that she is monogamous with a vasectomized partner, or practices abstinence and will continue to do so during the duration of study
  • Written informed consent.

Exclusion criteria

  • Known or suspected obstruction, gastric retention, ileus, perforation, fecal impaction or inflammatory bowel disease.
  • Prior small bowel or colonic resection or colostomy.
  • Weight < 80 lbs.
  • Unwilling or unable to undergo any colon diagnostic examinations at the end of the study if not performed within 5 years of the informed consent date advised by clinically accepted indications.
  • Positive stool hemoccult.
  • Significant cardiac, renal or hepatic insufficiency.
  • Pregnant or expecting to become pregnant within 120 days of study enrollment.
  • Lactating or breast feeding.
  • Subjects who in the opinion of the investigator would be unable to comply adequately with the study plan.
  • Use of investigational drugs in the last 30 days.
  • Patients with known allergy to PEG or PEG medications such as PEG or sulfate-free electrolyte lavage solutions

Trial contacts and locations

4

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems