Constipation Clinical Trial
— ACCESSOfficial title:
A Phase IIb, Double-blind, Randomised, Placebo-controlled, Multi-centre, Dose-finding Efficacy and Safety Study of a Range of Doses of A3309 in Patients With Chronic Idiopathic Constipation
| Verified date | October 2010 |
| Source | Albireo |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this trial is to determine the efficacy and safety of A3309 administered to patients with chronic idiopathic constipation.
| Status | Completed |
| Enrollment | 190 |
| Est. completion date | October 2010 |
| Est. primary completion date | October 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Patient meets protocol specified criteria for constipation - Patient has successfully completed study requirements with no clinically relevant findings for physical exam, ECG, laboratory tests and colonoscopy as applicable Exclusion Criteria: - Medical history or medical condition that would not make the patient a good candidate for the study or limit the patient´s ability to complete the study - Patient reports loose stools - Patient has IBS with pain/discomfort as predominant symptom - Patient needs medications prohibited as specified in the protocol |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Albireo Investigative Site | Albuquerque | New Mexico |
| United States | Albireo Investigative Site | Anaheim | California |
| United States | Albireo Investigative Site | Anderson | South Carolina |
| United States | Albireo Investigative Site | Annapolis | Maryland |
| United States | Albireo Investigative Site | Baltimore | Maryland |
| United States | Albireo Investigative Site | Boynton Beach | Florida |
| United States | Albireo Investigative Site | Chandler | Arizona |
| United States | Albireo Investigative Site | Charlotte | North Carolina |
| United States | Albireo Investigative Site | Chattanooga | Tennessee |
| United States | Albireo Investigative Site | Chesterfield | Michigan |
| United States | Albireo Investigative Site | Cincinnati | Ohio |
| United States | Albireo Investigative Site | Cincinnati | Ohio |
| United States | Albireo Investigative Site | Clive | Iowa |
| United States | Albireo Investigative Site | Colorado Springs | Colorado |
| United States | Albireo Investigative Site | Davenport | Iowa |
| United States | Albireo Investigative Site | Dayton | Ohio |
| United States | Albireo Investigative Site | El Paso | Texas |
| United States | Albireo Investigative Site | Encinitas | California |
| United States | Albireo Investigative Site | Great Neck | New York |
| United States | Albireo Investigative Site | Greensboro | North Carolina |
| United States | Albireo Investigative Site | Harrisburg | North Carolina |
| United States | Albireo Investigative Site | Henderson | Nevada |
| United States | Albireo Investigative Site | Hollywood | Maryland |
| United States | Albireo Investigative Site | Huntsville | Alabama |
| United States | Albireo Investigative Site | Inverness | Florida |
| United States | Albireo Investigative Site | Kingsport | Tennessee |
| United States | Albireo Investigative Site | La Crosse | Wisconsin |
| United States | Albireo Investigative Site | Levittown | Pennsylvania |
| United States | Albireo Investigative Site | Longview | Texas |
| United States | Albireo Investigative Site | Lynchburg | Virginia |
| United States | Albireo Investigative Site | Marlton | New Jersey |
| United States | Albireo Investigative Site | Mission | Kansas |
| United States | Albireo Investigative Site | Monroe | Louisiana |
| United States | Albireo Investigative Site | Ogden | Utah |
| United States | Albireo Investigative Site | Oklahoma City | Oklahoma |
| United States | Albireo Investigative Site | Overland Park | Kansas |
| United States | Albireo Investigative Site | Peoria | Illinois |
| United States | Albireo Investigative Site | Phoenix | Arizona |
| United States | Albireo Investigative Site | Salt Lake City | Utah |
| United States | Albireo Investigative Site | San Antonio | Texas |
| United States | Albireo Investigative Site | San Diego | California |
| United States | Albireo Investigative Site | Shreveport | Louisiana |
| United States | Albireo Investigative Site | Statesville | North Carolina |
| United States | Albireo Investigative Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Albireo |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline in frequency of spontaneous bowel movements | Weekly | No | |
| Secondary | Responder analyses for complete spontaneous bowel movements | weekly and for duration of study | No | |
| Secondary | Time to first bowel movement | First week | No |
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