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

NCT00583609 | Completed Phase 4

• 1 other identifier: 851-PP-03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Efficacy will be measured by analysis of patient self reported bowel movement (BM) data

  2 weeks

Secondary Outcomes (1)

• Adverse events

  2 weeks

Study Arms (1)

1

EXPERIMENTAL

PEG3350

Drug: PEG3350

Interventions

PEG3350 DRUG

PEG3350

1

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Braintree Laboratories: lead

Study Sites (2)

Unknown Facility

Little Rock, Arkansas, United States

Location

Unknown Facility

Morristown, New Jersey, United States

Location

MeSH Terms

Conditions

Constipation

Interventions

polyethylene glycol 3350

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• John McGowan

  Braintree Laboratories, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 31, 2007
• Study Start: September 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: September 28, 2009

Record last verified: 2009-09

Locations

US (2)