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

Constipation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00583609
• Other study ID #: 851-PP-03
• Status: Completed
• Phase: Phase 4
• First received: December 20, 2007
• Last updated: September 24, 2009
• Start date: September 2007
• Est. completion date: July 2008

Study information

• Verified date: September 2009
• Source: Braintree Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 16 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

Drug:
• PEG3350
PEG3350

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Braintree Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy will be measured by analysis of patient self reported bowel movement (BM) data		2 weeks	No
Secondary	Adverse events		2 weeks	Yes