Duloxetine vs. Placebo in the Treatment of Osteoarthritis Knee Pain - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

February 7, 2007

Last Updated Date

September 26, 2008

Start Date ^†

February 2007

Current Primary Outcome Measures ^†

Brief Pain Inventory (BPI) 24-hour average rating [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00433290 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Patient Global Impression of Improvement (PGI-I) [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
Western Ontario and McMaster Osteoarthritis Index (WOMAC) physical function, pain and stiffness subscale [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
Weekly mean of the 24-hour average pain and worst pain score [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
Clinical Global Impression of Severity (CGI-S) [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
Response to treatment, as defined by a ≥ 30% reduction of weekly mean in 24-hour average pain severity ratings computed from diary [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
Medical Outcomes Study Short Form-36 (SF-36) [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
EuroQoL Questionnaire - 5 Dimension [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
Beck Depression Inventory - II (BDI-II) [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
Hospital Anxiety and Depression Scale - anxiety subscale (HADS-A) [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
Discontinuation rates [ Time Frame: over 13 weeks ] [ Designated as safety issue: Yes ]
Treatment-emergent adverse events [ Time Frame: over 13 weeks ] [ Designated as safety issue: Yes ]
Laboratory assessments [ Time Frame: over 13 weeks ] [ Designated as safety issue: Yes ]
Vital signs [ Time Frame: over 13 weeks ] [ Designated as safety issue: Yes ]
Brief Pain Inventory (BPI)- Severity and Interference [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
Brief Pain Inventory (BPI)- Severity and Interference [ Time Frame: 7-13 weeks ] [ Designated as safety issue: No ]
Response to treatment as defined by a ≥ 30% reduction of weekly mean in 24-hour average pain severity ratings computed from diary [ Time Frame: 7-13 weeks ] [ Designated as safety issue: No ]
Adverse events reported as reasons for discontinuations [ Time Frame: over 13 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^†

The comparison between duloxetine and placebo on the endpoint PGI-I; The comparison between duloxetine and placebo on the change from baseline to endpoint on the WOMAC physical function score.

Descriptive Information

Brief Title ^†

Duloxetine vs. Placebo in the Treatment of Osteoarthritis Knee Pain

Official Title ^†

Protocol F1J-MC-HMFG Duloxetine 60 to 120 mg Versus Placebo in the Treatment of Patients With Osteoarthritis Knee Pain

Brief Summary

The primary purpose of this study is to determine if duloxetine reduces pain severity in patients with osteoarthritis knee pain.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Osteoarthritis Knee Pain

Intervention ^†

Drug: Duloxetine
Drug: Placebo

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 ^†

Completed

Enrollment ^†

255

Completion Date

May 2008

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Male or female outpatients with osteoarthritis knee pain.

Exclusion Criteria:

Serious cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study.
Previous exposure to duloxetine.

Gender

Both

Ages

40 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Greece, Russian Federation, Sweden

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00433290

Responsible Party

Chief Medical Officer, Eli Lilly

Secondary IDs ^††

F1J-MC-HMFG

Study Sponsor ^†

Eli Lilly and Company

Collaborators ^††

Investigators ^†

Study Director:

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

Information Provided By

Eli Lilly and Company

Verification Date

September 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.