Constipation
Conditions
Brief summary
To evaluate the safety and efficacy of extended use of polyethyleneglycol3350 laxative as compared to placebo in constipated patients.
Interventions
Sponsors
Braintree Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A successful outcome is defined as no longer meeting the definition of constipation using ROME I criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| Analysis of individual ROME I criteria | — |
| Safety (adverse events and laboratory testing) | — |
Countries
United States
Outcome results
None listed