Upper GI Handling of Branded vs. Generic Alendronate

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00400530
First received: November 16, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Randomized, Single-Blind Study to Evaluate Upper Gastrointestinal Handling of Branded Versus Generic Alendronate Tablets

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

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

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014