Upper GI Handling of Branded vs. Generic Alendronate

November 16, 2006 updated by: Merck Sharp & Dohme LLC

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

25

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Gamma camera imaging of tablet dissolution in oesophagus

Secondary Outcome Measures

Outcome Measure
Gamma camera dissolution of tablets in stomach

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Study Registration Dates

First Submitted

November 16, 2006

First Submitted That Met QC Criteria

November 16, 2006

First Posted (Estimate)

November 17, 2006

Study Record Updates

Last Update Posted (Estimate)

November 17, 2006

Last Update Submitted That Met QC Criteria

November 16, 2006

Last Verified

November 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006_050

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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