Upper GI Handling of Branded vs. Generic Alendronate

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00400530

First received: November 16, 2006

Last updated: NA

Last verified: November 2006

History: No changes posted

Tracking Information

First Received Date ^ICMJE

November 16, 2006

Last Updated Date

November 16, 2006

Start Date ^ICMJE

December 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Gamma camera imaging of tablet dissolution in oesophagus

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Gamma camera dissolution of tablets in stomach

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Upper GI Handling of Branded vs. Generic Alendronate

Official Title ^ICMJE

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment

Condition ^ICMJE

Osteoporosis

Intervention ^ICMJE

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

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00400530

Other Study ID Numbers ^ICMJE

2006_050

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

November 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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