Upper GI Handling of Branded vs. Generic Alendronate

This study has been completed.

First Received: November 16, 2006 No Changes Posted

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00400530

Purpose

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.

Condition	Intervention	Phase
Osteoporosis	Drug: MK0217, alendronate sodium / Duration of Treatment: 1 Month Drug: Comparator: Alendronate-Teva / Duration of Treatment: 1 Month	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Crossover Assignment, Pharmacokinetics Study
Official Title:	A Randomized, Single-Blind Study to Evaluate Upper Gastrointestinal Handling of Branded Versus Generic Alendronate Tablets

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis

Drug Information available for: Alendronate Alendronate sodium Fosamax

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Gamma camera imaging of tablet dissolution in oesophagus

Secondary Outcome Measures:

Gamma camera dissolution of tablets in stomach

Estimated Enrollment:	25
Study Start Date:	December 2005

Eligibility

Ages Eligible for Study:	55 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00400530

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Study ID Numbers:	2006_050
Study First Received:	November 16, 2006
Last Updated:	November 16, 2006
ClinicalTrials.gov Identifier:	NCT00400530 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Musculoskeletal Diseases
Alendronate
Osteoporosis

Bone Density Conservation Agents
Bone Diseases, Metabolic
Bone Diseases

Additional relevant MeSH terms:

Musculoskeletal Diseases
Alendronate
Physiological Effects of Drugs
Osteoporosis

Bone Density Conservation Agents
Bone Diseases, Metabolic
Bone Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 03, 2009