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Upper GI Handling of Branded vs. Generic Alendronate

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00400530
First Posted: November 17, 2006
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Merck Sharp & Dohme Corp.
November 16, 2006
November 17, 2006
October 12, 2017
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
Intervention Model: Crossover Assignment
Masking: Single
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
Sexes Eligible for Study: Female
55 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00400530
2006_050
Not Provided
Not Provided
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