A Pilot Study of a New PEG3350 Dose Formulation For Use in Constipated Children

This study has been completed.

Sponsor:

Information provided by:

Braintree Laboratories

ClinicalTrials.gov Identifier:

NCT00583609

First received: December 20, 2007

Last updated: September 24, 2009

Last verified: September 2009

Purpose

To evaluate the patient acceptance of a new PEG3350 dose formulation in children currently treated with PEG3350 powder for treatment of constipation.

Condition	Intervention	Phase
Constipation	Drug: PEG3350	Phase 4

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Constipation

U.S. FDA Resources

Further study details as provided by Braintree Laboratories:

Primary Outcome Measures:

Efficacy will be measured by analysis of patient self reported bowel movement (BM) data [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Estimated Enrollment:	20
Study Start Date:	September 2007
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 PEG3350	Drug: PEG3350 PEG3350

Eligibility

Criteria

Inclusion Criteria:

Male or female constipated outpatients between the ages of 4 and 16
Currently taking a dose of PEG 3350 powder up to a maximum of 17g per day that has been consistent for at least 4 weeks, or if less than 4 weeks, the investigator testifies that the patient is stable
Current treatment is considered successful - defined as greater than 2 bowel movements per week with no accidents
Are otherwise in good health, as judged by a physical examination
If female and of childbearing potential, patient must be 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 for the duration of the study
In the investigator's judgment, patient or guardian is mentally competent to sign an instrument of informed consent

Exclusion Criteria:

Patients who are impacted at baseline exam
Patients with known or suspected perforation or obstruction
Patients with a history of gastric retention, inflammatory bowel disease, bowel resection, or colostomy
Patients with a known history of organic cause for their constipation
Patients currently using medications known to cause constipation (these include opiates, antidepressants, SSRI's, antimotility agents and anticholinergics)
Patients who are breastfeeding, pregnant, or intend to become pregnant during the study
Female patients of childbearing potential who refuse a pregnancy test
Patients who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedure
Patients with known allergy to PEG or PEG containing medications
Patients who, within the past 30 days have participated in an investigational clinical study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00583609

Locations

United States, Arkansas

Little Rock, Arkansas, United States
United States, New Jersey

Morristown, New Jersey, United States

Sponsors and Collaborators

Braintree Laboratories

Investigators

Study Director:

John McGowan

Braintree Laboratories, Inc.

More Information

No publications provided

Responsible Party:	John McGowan, Clinical Operations Manager, Braintree Laboratories, Inc.
ClinicalTrials.gov Identifier:	NCT00583609 History of Changes
Other Study ID Numbers:	851-PP-03
Study First Received:	December 20, 2007
Last Updated:	September 24, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013