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

NCT ID: NCT00583609

Last Updated: 2009-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2008-07-31

Brief Summary

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

Conditions

Constipation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

PEG3350

Group Type: EXPERIMENTAL

PEG3350

Intervention Type: DRUG

PEG3350

Interventions

PEG3350

PEG3350

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Braintree Laboratories

INDUSTRY

Sponsor Role: lead

Responsible Party

Braintree Laboratories, Inc.

Principal Investigators

John McGowan

Role: STUDY_DIRECTOR

Braintree Laboratories, Inc.

Locations

Little Rock, Arkansas, United States

Morristown, New Jersey, United States

Countries

United States

Other Identifiers

851-PP-03

Identifier Type: -

Identifier Source: org_study_id