Upper GI Handling of Branded vs. Generic Alendronate
Phase 3
Completed
- Conditions
- Osteoporosis
- Registration Number
- NCT00400530
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 25
Inclusion Criteria
- 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
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Exclusion Criteria
- History of drug hypersensitivity
- Suffers from dysphagia, achalasia, or other conditions or medications affecting upper gastrointestinal motility
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Gamma camera imaging of tablet dissolution in oesophagus
- Secondary Outcome Measures
Name Time Method Gamma camera dissolution of tablets in stomach