An Open Label Study of Chronic Polyethyleneglycol3350 Use in Constipated Patients

This study has been completed.

Sponsor:

Information provided by:

Braintree Laboratories

ClinicalTrials.gov Identifier:

NCT00164125

First received: September 9, 2005

Last updated: February 6, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

February 6, 2013

Start Date ^ICMJE

July 2003

Primary Completion Date

November 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety (Adverse events and laboratory testing)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00164125 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Assessment of constipation using ROME I criteria and analysis of individual ROME I criteria

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

An Open Label Study of Chronic Polyethyleneglycol3350 Use in Constipated Patients

Official Title ^ICMJE

An Open Label Study of Chronic Polyethyleneglycol3350 Use in Constipated Patients

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Constipation

Intervention ^ICMJE

Drug: polyethyleneglycol3350

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

300

Completion Date

Not Provided

Primary Completion Date

November 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Not Provided

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00164125

Other Study ID Numbers ^ICMJE

851-CR3

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Braintree Laboratories

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jorge Herrera, MD

University of South Alabama

Information Provided By

Braintree Laboratories

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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