Extended Use of Polyethyleneglycol3350 Laxative in Constipated Patients

Braintree Laboratories

Status and phase

Completed

Phase 4

Conditions

Constipation

Treatments

Drug: polyethyleneglycol3350

Study type

Interventional

Funder types

Industry

Identifiers

NCT00153153

851-CR1

Details and patient eligibility

About

To evaluate the safety and efficacy of extended use of polyethyleneglycol3350 laxative as compared to placebo in constipated patients.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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