Overview

Extended Use of Polyethyleneglycol3350 Laxative in Constipated Patients

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
To evaluate the safety and efficacy of extended use of polyethyleneglycol3350 laxative as compared to placebo in constipated patients.
Phase:
Phase 4
Details
Lead Sponsor:
Braintree Laboratories
Treatments:
Laxatives
Polyethylene glycol 3350
Criteria
Inclusion Criteria:

- Male or female outpatients at least 18 years of age

- Constipated according to ROME I criteria

- On average, fewer than 3 satisfactory BMs per week during the observation period

- If female and of childbearing potential, patient must be surgically sterilized or
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 during the duration of study

- Are otherwise in good health, as judged by a physical examination

- In the investigator's judgment, patient is mentally competent to sign an instrument of
informed consent

Exclusion Criteria:

- Patients with heme positive stool at screening. Patients with heme positive stool that
can be attributed to hemorrhoids or anal fissures are eligible for inclusion.

- Patients with hypo- or hyperthyroidism as determined by history, or screening TSH
results.

- Patients with known or suspected perforation or obstruction.

- History of gastric retention, inflammatory bowel disease, bowel resection, or
colostomy.

- Patients with a known history of organic cause for their constipation.

- Patients meeting the ROME definition of Irritable Bowel Syndrome

- Patients currently taking any of the following medications that are known to effect
bowel habits:

- Antidiarrheals

- Antacids containing magnesium or aluminum salts

- Anticholinergics

- Antispasmodic agents

- Erythromycin and other macrolides

- Octreotide

- Lotronex, Zofran, or other 5-HT3 antagonists

- Zelnorm, or other 5-HT4 agonists

- Opiods/narcotic analgesics

- Prokinetics

- Serotonin re-uptake inhibitors or tricyclic antidepressants

- Calcium antagonists

- Patients who are breastfeeding, pregnant, or intend to become pregnant during the
study.

- Female patients of childbearing potential who refuse a pregnancy test.

- Patients with a known allergy to corn or polyethylene glycol.

- Patients who, in the opinion of the investigator, should not be included in the study
for any reason, including inability to follow study procedures.

- Patients who, within the past 30 days have participated in an investigational clinical
study

- Patients that have undergone a colonoscopy within 30 days of beginning the 14 day
observation period.

- Patients that are currently taking, or have previously been treated with
polyethyleneglycol3350