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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 19, 2014