A Research Study to Test the Effectiveness of MK0217 in Patients With Paget's Bone Disease - Tabular View

Tracking Information

First Received Date ^ICMJE

May 30, 2007

Last Updated Date

September 30, 2008

Start Date ^ICMJE

October 2001

Primary Completion Date

October 2002 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Patients will have a decrease of at least 30% in their blood alkaline phosphatase level after 6 months

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00480662 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

MK0217 will be safely tolerated

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

A Research Study to Test the Effectiveness of MK0217 in Patients With Paget's Bone Disease

Official Title ^ICMJE

A 6-Month, Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Alendronate 280-mg Oral Buffered Solution Once Weekly in Patients With Paget's Disease of Bone

Brief Summary

To test the safety, effectiveness of MK0217 when taken once a week for six months in treating patients with Paget's bone disease.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Paget's Disease of Bone

Intervention ^ICMJE

Drug: alendronate

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 ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

October 2002 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male or female, ages 18 to 90 years with a diagnosis of Paget's bone disease

Exclusion Criteria:

Patient cannot stand or sit upright for at least 30 minutes
Patient has difficulty swallowing or problems with digestive system

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00480662

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Study ID Numbers ^ICMJE

2007_555, MK0217-206

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

September 2008

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