Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the safety of extended use of polyethyleneglycol3350 laxative in constipated patients.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| polyethyleneglycol3350 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Safety (Adverse events and laboratory testing) |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of constipation using ROME I criteria and analysis of individual ROME I criteria |
Not provided
Inclusion Criteria:
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:
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jorge Herrera, MD | University of South Alabama | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hoover | Alabama | 35216 | United States | |||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Mobile |
| Alabama |
| 36693 |
| United States |
| Pell City | Alabama | 35128 | United States |
| Tallassee | Alabama | 36078 | United States |
| Glendale | Arizona | 85306 | United States |
| Phoenix | Arizona | 85013 | United States |
| Scottsdale | Arizona | 85251 | United States |
| Tucson | Arizona | 85712 | United States |
| Anaheim | California | 92801 | United States |
| Sacramento | California | 95825 | United States |
| Washington D.C. | District of Columbia | 20037 | United States |
| Kissimmee | Florida | 34741 | United States |
| Lake Worth | Florida | 33461 | United States |
| Largo | Florida | 33770 | United States |
| Ocoee | Florida | 34761 | United States |
| St. Petersburg | Florida | 33702 | United States |
| St. Petersburg | Florida | 33707 | United States |
| West Palm Beach | Florida | 33407 | United States |
| Atlanta | Georgia | 30328 | United States |
| Marietta | Georgia | 30067 | United States |
| Oakbrook Terrace | Illinois | 60181 | United States |
| Peoria | Illinois | 61602 | United States |
| Overland Park | Kansas | 66215 | United States |
| Laurel | Maryland | 20707 | United States |
| Springfield | Massachusetts | 01107 | United States |
| St Louis | Missouri | 63017 | United States |
| South Bound Brook | New Jersey | 08880 | United States |
| Raleigh | North Carolina | 27609 | United States |
| Raleigh | North Carolina | 27612 | United States |
| Wilmington | North Carolina | 28401 | United States |
| Cincinnati | Ohio | 45236 | United States |
| Cincinnati | Ohio | 45242 | United States |
| Columbus | Ohio | 43212 | United States |
| Greer | South Carolina | 29651 | United States |
| Bristol | Tennessee | 37620 | United States |
| Kingsport | Tennessee | 37660 | United States |
| Memphis | Tennessee | 38120 | United States |
| Austin | Texas | 78705 | United States |
| Austin | Texas | 78745 | United States |
| Dallas | Texas | 75231 | United States |
| Fort Worth | Texas | 76135 | United States |
| San Angelo | Texas | 76904 | United States |
| Salt Lake City | Utah | 84121 | United States |
| Newport News | Virginia | 23606 | United States |
| Norfolk | Virginia | 23502 | United States |
| Richmond | Virginia | 23294 | United States |
| Virginia Beach | Virginia | 23454 | United States |
| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided