An Open Label Study of Chronic Polyethyleneglycol3350 Use in Constipated Patients

Constipation Clinical Trial

Official title:

An Open Label Study of Chronic Polyethyleneglycol3350 Use in Constipated Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00164125
• Other study ID #: 851-CR3
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2005
• Last updated: February 6, 2013
• Start date: July 2003

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

To evaluate the safety of extended use of polyethyleneglycol3350 laxative in constipated patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. primary completion date: November 2004
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Inclusion Criteria:

• Male or female outpatients at least 18 years of age

• Constipated according to ROME I criteria

• 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

• Are otherwise in good health, as judged by a physical examination

• In the investigator's judgment, patient is mentally competent to sign an instrument of informed consent

Exclusion Criteria:

• Patients with heme positive stool at screening. Patients with heme positive stool that can be attributed to hemorrhoids or anal fissures are eligible for inclusion.

• Patients with hypo- or hyperthyroidism as determined by history, or screening TSH results.

• Patients with known or suspected perforation or obstruction.

• History of gastric retention, inflammatory bowel disease, bowel resection, or colostomy.

• Patients with a known history of organic cause for their constipation.

• Patients meeting the ROME definition of Irritable Bowel Syndrome

• Patients currently taking any of the following medications that are known to effect bowel habits:

• Antidiarrheals

• Antacids containing magnesium or aluminum salts

• Anticholinergics

• Antispasmodic agents

• Erythromycin and other macrolides

• Octreotide

• Lotronex, Zofran, or other 5-HT3 antagonists

• Zelnorm, or other 5-HT4 agonists

• Opiods/narcotic analgesics

• Prokinetics

• Serotonin re-uptake inhibitors or tricyclic antidepressants

• Calcium antagonists

• Patients who are breastfeeding, pregnant, or intend to become pregnant during the study.

• Female patients of childbearing potential who refuse a pregnancy test.

• Patients with a known allergy to polyethyleneglycol.

• Patients who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures.

• Patients who, within the past 30 days have participated in an investigational clinical study

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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	Safety (Adverse events and laboratory testing)
Secondary	Assessment of constipation using ROME I criteria and analysis of individual ROME I criteria