Back to resultsUpper GI Handling of Branded vs. Generic Alendronate
Primary Purpose
Osteoporosis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0217, alendronate sodium / Duration of Treatment: 1 Month
Comparator: Alendronate-Teva / Duration of Treatment: 1 Month
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Gamma camera imaging of tablet dissolution in oesophagus
Secondary Outcome Measures
Gamma camera dissolution of tablets in stomach
Full Information
NCT ID
NCT00400530
First Posted
November 16, 2006
Last Updated
November 16, 2006
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00400530
Brief Title
Upper GI Handling of Branded vs. Generic Alendronate
Official Title
A Randomized, Single-Blind Study to Evaluate Upper Gastrointestinal Handling of Branded Versus Generic Alendronate Tablets
Study Type
Interventional
2. Study Status
Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Single
Allocation
Randomized
Enrollment
25 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0217, alendronate sodium / Duration of Treatment: 1 Month
Intervention Type
Drug
Intervention Name(s)
Comparator: Alendronate-Teva / Duration of Treatment: 1 Month
Primary Outcome Measure Information:
Title
Gamma camera imaging of tablet dissolution in oesophagus
Secondary Outcome Measure Information:
Title
Gamma camera dissolution of tablets in stomach
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Upper GI Handling of Branded vs. Generic Alendronate
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