Duloxetine Versus Placebo in Chronic Low Back Pain

Back Pain Without Radiation Clinical Trial

Official title:

Protocol F1J-MC-HMEO Duloxetine Versus Placebo in the Treatment of Chronic Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00408876
• Other study ID #: 10545
• Secondary ID: F1J-MC-HMEO
• Status: Completed
• Phase: Phase 3
• First received: December 6, 2006
• Last updated: November 19, 2009
• Start date: December 2006
• Est. completion date: November 2007

Study information

• Verified date: November 2009
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary purpose of your participation in this study is to help answer the following research question, and not to provide you treatment for your condition--Whether duloxetine once daily can help patients with Chronic Low Back Pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 404
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: - Male/Female outpatients 18 years of age with chronic low back pain. Exclusion Criteria: - You have a serious or unstable disease of the heart or blood vessels, liver, kidney, lungs, or blood-related illness, problems with decreased blood flow to arms and legs (peripheral vascular disease), or other medical conditions, or psychiatric conditions that, in the opinion of the investigator, would affect your participation or be likely to lead to hospitalization during the course of the study. - Have acute liver injury (such as hepatitis) or severe cirrhosis. - Have had previous exposure to duloxetine. - Have a body mass index (BMI) over 40. - Have major depressive disorder. - Require daily narcotics.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Back Pain Without Radiation
• Low Back Pain

Intervention

Drug:
• Duloxetine

• Placebo

Locations

Country	Name	City	State
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph	Fort Myers	Florida
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph	Orlando	Florida
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph	South Miami	Florida
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Week 1 in Weekly Mean of the 24-hour Average Pain Scores		Baseline, Week 1	No
Primary	Change From Baseline to Week 2 in Weekly Mean of the 24-Hour Average Pain Scores		Baseline, Week 2	No
Primary	Change From Baseline to Week 3 in Weekly Mean of the 24-Hour Average Pain Scores		Baseline, Week 3	No
Primary	Change From Baseline to Week 4 in Weekly Mean of the 24-Hour Average Pain Scores		Baseline, Week 4	No
Primary	Change From Baseline to Week 5 in Weekly Mean of the 24-Hour Average Pain Scores		Baseline, Week 5	No
Primary	Change From Baseline to Week 6 in Weekly Mean of the 24-Hour Average Pain Scores		Baseline, Week 6	No
Primary	Change From Baseline to Week 7 in Weekly Mean of the 24-Hour Average Pain Scores		Baseline, Week 7	No
Primary	Change From Baseline to Week 8 in Weekly Mean of the 24-Hour Average Pain Scores		Baseline, Week 8	No
Primary	Change From Baseline to Week 9 in Weekly Mean of the 24-Hour Average Pain Scores		Baseline, Week 9	No
Primary	Change From Baseline to Week 10 in Weekly Mean of the 24-Hour Average Pain Scores		Baseline, Week 10	No
Primary	Change From Baseline to Week 11 in Weekly Mean of the 24-Hour Average Pain Scores		Baseline, Week 11	No
Primary	Change From Baseline to Week 12 in Weekly Mean of the 24-Hour Average Pain Scores		Baseline, Week 12	No
Primary	Change From Baseline to Week 13 Endpoint in Weekly Mean of the 24-Hour Average Pain Scores		Baseline, Week 13	No
Secondary	Patient's Global Impression - Improvement (PGI-I) at Week 13 Endpoint		Week 13	No
Secondary	Change From Baseline to Week 13 Endpoint in Roland-Morris Disability Questionnaire (RMDQ) Total Score		Baseline, Week 13	No
Secondary	Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean 24-Hour Night Pain Score		Baseline, Week 13	No
Secondary	Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean of Worst Pain Score		Baseline, Week 13	No
Secondary	Change From Baseline to Week 13 Endpoint in Clinical Global Impression of Severity		Baseline, Week 13	No
Secondary	Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Worst Pain Score		Baseline, Week 13	No
Secondary	Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Least Pain Score		Baseline, Week 13	No
Secondary	Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Average Pain Score		Baseline, Week 13	No
Secondary	Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Pain Right Now Score		Baseline, Week 13	No
Secondary	Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - General Activity		Baseline, Week 13	No
Secondary	Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Mood		Baseline, Week 13	No
Secondary	Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Walking Ability		Baseline, Week 13	No
Secondary	Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Normal Work		Baseline, Week 13	No
Secondary	Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Relations With Other People		Baseline, Week 13	No
Secondary	Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Sleep		Baseline, Week 13	No
Secondary	Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Enjoyment of Life		Baseline, Week 13	No
Secondary	Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Average Interference		Baseline, Week 13	No
Secondary	Response to Treatment, as Defined by a 30% Reduction of Weekly Mean Score in 24-hour Average Pain Severity Ratings, Last Observation Carried Forward		Baseline to Week 13	No
Secondary	Response to Treatment, as Defined by a 50% Reduction of Weekly Mean Score in 24-hour Average Pain Severity Ratings, Last Observation Carried Forward		Baseline to Week 13	No
Secondary	Change From Baseline to Week 13 Endpoint in Athens Insomnia Scale		Baseline, Week 13	No
Secondary	Change From Baseline to Week 13 Endpoint in the 36-item Short-Form Health Survey (SF36)- Mental Component Summary (MCS)		Baseline, Week 13	No
Secondary	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Component Summary (PCS)		Baseline, Week 13	No
Secondary	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Bodily Pain		Baseline, Week 13	No
Secondary	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - General Health		Baseline, Week 13	No
Secondary	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Mental Health		Baseline, Week 13	No
Secondary	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Functioning		Baseline, Week 13	No
Secondary	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Emotional		Baseline, Week 13	No
Secondary	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Physical		Baseline, Week 13	No
Secondary	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Social Functioning		Baseline, Week 13	No
Secondary	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Vitality		Baseline, Week 13	No
Secondary	Change From Baseline to Week 13 Endpoint in the Euro-Quality of Life Questionnaire - 5 Dimension - US Based Index Score		Baseline, Week 13	No
Secondary	Change From Baseline to Week 13 Endpoint in Beck Depression Inventory-II Total Score		Baseline, Week 13	No
Secondary	Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale		Baseline, Week 13	No
Secondary	Adverse Events Reported as Reason for Discontinuation		Baseline to Week 13	Yes
Secondary	Change From Baseline to Week 13 Endpoint in Laboratory Assessments - Alkaline Phosphatase		Baseline, Week 13	Yes
Secondary	Change From Baseline to 13 Week Endpoint in Laboratory Assessments - Alanine Transaminase		Baseline, Week 13	Yes
Secondary	Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bicarbonate, HCO3		Baseline, Week 13	Yes
Secondary	Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Direct		Baseline, Week 13	Yes
Secondary	Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Total		Baseline, Week 13	Yes
Secondary	Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Chloride		Baseline, Week 13	Yes
Secondary	Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Cholesterol		Baseline, Week 13	Yes
Secondary	Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Creatinine		Baseline, Week 13	Yes
Secondary	Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Potassium		Baseline, Week 13	Yes
Secondary	Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Uric Acid		Baseline, Week 13	Yes
Secondary	Change From Baseline to Week 13 Endpoint in Vital Signs - Pulse Rate		Baseline, Week 13	Yes
Secondary	Change From Baseline to Week 13 Endpoint in Vital Signs - Systolic Blood Pressure		Baseline, Week 13	Yes
Secondary	Change From Baseline to Week 13 Endpoint in Vital Signs - Diastolic Blood Pressure		Baseline, Week 13	Yes
Secondary	Change From Baseline to Week 13 Endpoint in Vital Signs - Weight		Baseline, Week 13	Yes