Duloxetine Versus Placebo in Chronic Low Back Pain
Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Back Pain Without Radiation
Intervention: Duloxetine (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Eli Lilly and Company Official(s) and/or principal investigator(s): 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), Study Director, Affiliation: Eli Lilly and Company
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.
Clinical Details
Official title: Protocol F1J-MC-HMEO Duloxetine Versus Placebo in the Treatment of Chronic Low Back Pain
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
Primary outcome: Change From Baseline to Week 1 in Weekly Mean of the 24-hour Average Pain ScoresChange From Baseline to Week 2 in Weekly Mean of the 24-Hour Average Pain Scores Change From Baseline to Week 3 in Weekly Mean of the 24-Hour Average Pain Scores Change From Baseline to Week 4 in Weekly Mean of the 24-Hour Average Pain Scores Change From Baseline to Week 5 in Weekly Mean of the 24-Hour Average Pain Scores Change From Baseline to Week 6 in Weekly Mean of the 24-Hour Average Pain Scores Change From Baseline to Week 7 in Weekly Mean of the 24-Hour Average Pain Scores Change From Baseline to Week 8 in Weekly Mean of the 24-Hour Average Pain Scores Change From Baseline to Week 9 in Weekly Mean of the 24-Hour Average Pain Scores Change From Baseline to Week 10 in Weekly Mean of the 24-Hour Average Pain Scores Change From Baseline to Week 11 in Weekly Mean of the 24-Hour Average Pain Scores Change From Baseline to Week 12 in Weekly Mean of the 24-Hour Average Pain Scores Change From Baseline to Week 13 Endpoint in Weekly Mean of the 24-Hour Average Pain Scores
Secondary outcome: Patient's Global Impression - Improvement (PGI-I) at Week 13 EndpointChange From Baseline to Week 13 Endpoint in Roland-Morris Disability Questionnaire (RMDQ) Total Score Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean 24-Hour Night Pain Score Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean of Worst Pain Score Change From Baseline to Week 13 Endpoint in Clinical Global Impression of Severity Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Worst Pain Score Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Least Pain Score Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Average Pain Score Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Pain Right Now Score Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - General Activity Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Mood Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Walking Ability Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Normal Work Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Relations With Other People Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Sleep Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Enjoyment of Life Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Average Interference Response to Treatment, as Defined by a 30% Reduction of Weekly Mean Score in 24-hour Average Pain Severity Ratings, Last Observation Carried Forward Response to Treatment, as Defined by a 50% Reduction of Weekly Mean Score in 24-hour Average Pain Severity Ratings, Last Observation Carried Forward Change From Baseline to Week 13 Endpoint in Athens Insomnia Scale Change From Baseline to Week 13 Endpoint in the 36-item Short-Form Health Survey (SF36)- Mental Component Summary (MCS) Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Component Summary (PCS) Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Bodily Pain Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - General Health Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Mental Health Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Functioning Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Emotional Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Physical Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Social Functioning Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Vitality Change From Baseline to Week 13 Endpoint in the Euro-Quality of Life Questionnaire - 5 Dimension - US Based Index Score Change From Baseline to Week 13 Endpoint in Beck Depression Inventory-II Total Score Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Adverse Events Reported as Reason for Discontinuation Change From Baseline to Week 13 Endpoint in Laboratory Assessments - Alkaline Phosphatase Change From Baseline to 13 Week Endpoint in Laboratory Assessments - Alanine Transaminase Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bicarbonate, HCO3 Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Direct Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Total Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Chloride Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Cholesterol Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Creatinine Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Potassium Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Uric Acid Change From Baseline to Week 13 Endpoint in Vital Signs - Pulse Rate Change From Baseline to Week 13 Endpoint in Vital Signs - Systolic Blood Pressure Change From Baseline to Week 13 Endpoint in Vital Signs - Diastolic Blood Pressure Change From Baseline to Week 13 Endpoint in Vital Signs - Weight
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
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 33912, 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 32806, 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 33143, 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 33606, United States
Additional Information
Starting date: December 2006
Last updated: November 19, 2009
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