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:


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:
  • Adverse events [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   4 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 April 15, 2014