Status:
COMPLETED
An Open Label Study of Chronic Polyethyleneglycol3350 Use in Constipated Patients
Lead Sponsor:
Braintree Laboratories
Conditions:
Constipation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To evaluate the safety of extended use of polyethyleneglycol3350 laxative in constipated patients.
Eligibility Criteria
Inclusion
- Male or female outpatients at least 18 years of age
- Constipated according to ROME I criteria
- 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
- 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 polyethyleneglycol.
- 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
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00164125
Start Date
July 1 2003
Last Update
February 7 2013
Active Locations (47)
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1
Hoover, Alabama, United States, 35216
2
Mobile, Alabama, United States, 36693
3
Pell City, Alabama, United States, 35128
4
Tallassee, Alabama, United States, 36078