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NCT00400530 Clinical Trial

Upper GI Handling of Branded vs. Generic Alendronate

Osteoporosis Clinical Trial

Official title:
A Randomized, Single-Blind Study to Evaluate Upper Gastrointestinal Handling of Branded Versus Generic Alendronate Tablets

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00400530
Other study ID # 2006_050
Secondary ID
Status Completed
Phase Phase 3
First received November 16, 2006
Last updated November 16, 2006
Start date December 2005

Study information
Verified date November 2006
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 55 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MK0217, alendronate sodium / Duration of Treatment: 1 Month

• Comparator: Alendronate-Teva / Duration of Treatment: 1 Month

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Outcome
Type Measure Description Time frame Safety issue
Primary Gamma camera imaging of tablet dissolution in oesophagus
Secondary Gamma camera dissolution of tablets in stomach
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