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

Constipation Clinical Trial

Official title:

Comparison of Braintree PolyethyleneGlycol(PEG) Laxative and Placebo for Relief of Constipation From Constipating Medications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00153127
• Other study ID #: 851-17
• Status: Completed
• Phase: Phase 4
• First received: September 7, 2005
• Last updated: February 6, 2013
• Start date: November 2001

Study information

• Verified date: February 2013
• Source: Braintree Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. primary completion date: September 2004
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Constipation

Intervention

Drug:
• polyethyleneglycol3350

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	A successful outcome is defined as no longer meeting the definition of constipation using ROME I criteria
Secondary	Analysis of individual ROME I criteria
Secondary	Safety (adverse event and laboratory testing)