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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00583609
Recruitment Status : Completed
First Posted : December 31, 2007
Last Update Posted : September 28, 2009
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Constipation Drug: PEG3350 Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2007
Primary Completion Date : July 2008
Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
PEG3350
Drug: PEG3350
PEG3350


Outcome Measures

Primary Outcome Measures :
  1. Efficacy will be measured by analysis of patient self reported bowel movement (BM) data [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 2 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: John McGowan, Clinical Operations Manager, Braintree Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00583609     History of Changes
Other Study ID Numbers: 851-PP-03
First Posted: December 31, 2007    Key Record Dates
Last Update Posted: September 28, 2009
Last Verified: September 2009

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Polyethylene glycol 3350
Laxatives
Gastrointestinal Agents