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Upper GI Handling of Branded vs. Generic Alendronate

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00400530
First received: November 16, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted

November 16, 2006
November 16, 2006
December 2005
Not Provided
Gamma camera imaging of tablet dissolution in oesophagus
Same as current
No Changes Posted
Gamma camera dissolution of tablets in stomach
Same as current
Not Provided
Not Provided
 
Upper GI Handling of Branded vs. Generic Alendronate
A Randomized, Single-Blind Study to Evaluate Upper Gastrointestinal Handling of Branded Versus Generic Alendronate Tablets

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
Osteoporosis
  • Drug: MK0217, alendronate sodium / Duration of Treatment: 1 Month
  • Drug: Comparator: Alendronate-Teva / Duration of Treatment: 1 Month
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
Not Provided
Not Provided

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

Exclusion Criteria:

  • History of drug hypersensitivity
  • Suffers from dysphagia, achalasia, or other conditions or medications affecting upper gastrointestinal motility
Female
55 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00400530
2006_050
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP