Upper GI Handling of Branded vs. Generic Alendronate - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

November 16, 2006

Last Updated Date

November 16, 2006

Start Date ^†

December 2005

Current Primary Outcome Measures ^†

Gamma camera imaging of tablet dissolution in oesophagus

Original Primary Outcome Measures ^†

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^†

Gamma camera dissolution of tablets in stomach

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

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

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

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Single Blind, Active Control, Crossover Assignment, Pharmacokinetics Study

Condition ^†

Osteoporosis

Intervention ^†

Drug: MK0217, alendronate sodium / Duration of Treatment: 1 Month
Drug: Comparator: Alendronate-Teva / Duration of Treatment: 1 Month

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

Primary Completion Date

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

Gender

Female

Ages

55 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00400530

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Merck

Collaborators ^††

Investigators ^†

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

November 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.