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

Phase 4

Completed

• Conditions: Constipation
• Interventions: Drug: PEG3350

• Registration Number: NCT00583609
• Lead Sponsor: Braintree Laboratories

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-28
• Study First Posted: 2007-12-31
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2009-09
• Disposition First Submitted: 2009-09-24
• Disposition First Submitted QC: 2009-09-24
• Last Update Submitted: 2009-09-24
• Disposition First Posted: 2009-09-28
• Last Update Posted: 2009-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	PEG3350	PEG3350

Primary Outcome Measures

Name	Time	Method
Efficacy will be measured by analysis of patient self reported bowel movement (BM) data	2 weeks

Secondary Outcome Measures

Name	Time	Method
Adverse events	2 weeks