Upper GI Handling of Branded vs. Generic Alendronate | NCT00400530

Studies
Upper GI Handling of Branded vs. Generic Alendronate

NCT00400530

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

Nov 17, 2006Estimated

Enrollment

Phase

Phase 3

Conditions

Osteoporosis

Interventions

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

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2005

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 16, 2006

First Submission Date that Met QC Criteria

Nov 16, 2006

First Posted Date

Nov 17, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 16, 2006

Last Update Posted Date

Nov 17, 2006Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Measure	Description	Time Frame
Gamma camera imaging of tablet dissolution in oesophagus

Measure	Description	Time Frame
Gamma camera dissolution of tablets in stomach

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Monitor	Merck Sharp & Dohme LLC	Study Director

Type	Date	Date Unknown
Release	Feb 10, 2014
Unrelease		Yes
Release	Feb 14, 2014
Reset	Mar 28, 2014
Release	Dec 8, 2015
Reset	Jan 11, 2016

Condition Browse Module

MeSH Terms

ID	Term
D010024	Osteoporosis

Ancestor Terms

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019386	Alendronate
D000081206	Duration of Therapy

Ancestor Terms

ID	Term
D004164	Diphosphonates
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Feb 10, 2014		Yes
Feb 14, 2014

Name	Type	Description	Arm Group Labels	Other Names
MK0217, alendronate sodium / Duration of Treatment: 1 Month	Drug
Comparator: Alendronate-Teva / Duration of Treatment: 1 Month	Drug