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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


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
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