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

September 24, 2009 updated by: Braintree Laboratories
To evaluate the patient acceptance of a new PEG3350 dose formulation in children currently treated with PEG3350 powder for treatment of constipation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
PEG3350
Drug: PEG3350
PEG3350

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy will be measured by analysis of patient self reported bowel movement (BM) data
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Braintree Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

December 20, 2007

First Submitted That Met QC Criteria

December 28, 2007

First Posted (Estimate)

December 31, 2007

Study Record Updates

Last Update Posted (Estimate)

September 28, 2009

Last Update Submitted That Met QC Criteria

September 24, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 851-PP-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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