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The purpose of this study is to compare the safety and efficacy of extended polyethyleneglycol3350 use to tegaserod in patients with chronic constipation.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| polyethyleneglycol3350 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| A successful outcome is defined as no longer meeting the definition of constipation using ROME I criteria |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of individual ROME I criteria | ||
| Safety (adverse event review) |
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Inclusion Criteria:
Exclusion Criteria:
Patients with heme positive stool at screening that is not associated with hemorrhoids or anal fissures.
Patients with hypo- or hyperthyroidism as determined by medical history.
Patients with severe renal impairment.
Patients with moderate or severe hepatic impairment.
Patients with known or suspected perforation or obstruction.
History of gastric retention, inflammatory bowel disease, bowel resection, or colostomy.
Patients with symptomatic gallbladder disease, suspected sphincter of Oddi dysfunction, or abdominal adhesions.
Patients with a known history of organic cause for their constipation.
Patients currently taking, or planning to take 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 tegaserod (or any of its excipients) or 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.
Patients that have undergone a colonoscopy within 30 days of screening
Patients that are currently taking, or have previously been treated with polyethyleneglycol3350 or tegaserod.
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| Name | Affiliation | Role |
|---|---|---|
| Jorge Herrera, MD | University of South Alabama | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile | Alabama | 36693 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17573794 | Derived | Di Palma JA, Cleveland MV, McGowan J, Herrera JL. A randomized, multicenter comparison of polyethylene glycol laxative and tegaserod in treatment of patients with chronic constipation. Am J Gastroenterol. 2007 Sep;102(9):1964-71. doi: 10.1111/j.1572-0241.2007.01365.x. Epub 2007 Jun 15. |
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| Glendale |
| Arizona |
| 85306 |
| United States |
| Anaheim | California | 92801 | United States |
| Sacramento | California | 95825 | United States |
| San Diego | California | 92103 | United States |
| Lake Worth | Florida | 33461 | United States |
| Largo | Florida | 33770 | United States |
| St. Petersburg | Florida | 33707 | United States |
| Laurel | Maryland | 20707 | United States |
| Brighton | Massachusetts | 02135 | United States |
| St Louis | Missouri | 63017 | United States |
| Raleigh | North Carolina | 27609 | United States |
| Raleigh | North Carolina | 27612 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Cincinnati | Ohio | 45236 | United States |
| Greer | South Carolina | 29651 | United States |
| Memphis | Tennessee | 38120 | United States |
| Austin | Texas | 78705 | United States |
| Dallas | Texas | 75234 | 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 |
| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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