Constipation
Conditions
Brief summary
To evaluate the safety of extended use of polyethyleneglycol3350 laxative in constipated patients.
Interventions
Sponsors
Braintree Laboratories
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Inclusion Criteria: * 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 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety (Adverse events and laboratory testing) | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of constipation using ROME I criteria and analysis of individual ROME I criteria | — |
Countries
United States
Outcome results
None listed