Status:
COMPLETED
Upper GI Handling of Branded vs. Generic Alendronate
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Osteoporosis
Eligibility:
FEMALE
55-75 years
Phase:
PHASE3
Brief Summary
To compare upper GI handling of fosamax and generic, because the main AE profile of alendronate is before systemic absorption in the esophagus; differences could be relevant to the side effect profile...
Eligibility Criteria
Inclusion
- Post-menopausal females aged greater 55 years
- Prescribed alendronate 70 mg tablets for a therapeutic indication throughout the previous 3 months and expected to continue on this treatment for the duration of the study
- Willing to abstain from alcohol for 24 hours before each dose and until the end of each study day
- Willing to abstain from smoking for 24 hours before each dose and until the end of each study day
Exclusion
- History of drug hypersensitivity
- Suffers from dysphagia, achalasia, or other conditions or medications affecting upper gastrointestinal motility
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00400530
Start Date
December 1 2005
Last Update
November 17 2006
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