Clinical trial NCT00408876: Duloxetine Versus Placebo in Chronic Low Back Pain
Official title: Protocol F1J-MC-HMEO Duloxetine Versus Placebo in the Treatment of Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Back Pain Without Radiation
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2006-12-07
Enrollment: 404
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Change From Baseline to Week 1 in Weekly Mean of the 24-hour Average Pain Scores
timeFrame: Baseline, Week 1
measure: Change From Baseline to Week 2 in Weekly Mean of the 24-Hour Average Pain Scores
timeFrame: Baseline, Week 2
measure: Change From Baseline to Week 3 in Weekly Mean of the 24-Hour Average Pain Scores
timeFrame: Baseline, Week 3
measure: Change From Baseline to Week 4 in Weekly Mean of the 24-Hour Average Pain Scores
timeFrame: Baseline, Week 4
measure: Change From Baseline to Week 5 in Weekly Mean of the 24-Hour Average Pain Scores
timeFrame: Baseline, Week 5
measure: Change From Baseline to Week 6 in Weekly Mean of the 24-Hour Average Pain Scores
timeFrame: Baseline, Week 6
measure: Change From Baseline to Week 7 in Weekly Mean of the 24-Hour Average Pain Scores
timeFrame: Baseline, Week 7
measure: Change From Baseline to Week 8 in Weekly Mean of the 24-Hour Average Pain Scores
timeFrame: Baseline, Week 8
measure: Change From Baseline to Week 9 in Weekly Mean of the 24-Hour Average Pain Scores
timeFrame: Baseline, Week 9
measure: Change From Baseline to Week 10 in Weekly Mean of the 24-Hour Average Pain Scores
timeFrame: Baseline, Week 10
measure: Change From Baseline to Week 11 in Weekly Mean of the 24-Hour Average Pain Scores
timeFrame: Baseline, Week 11
measure: Change From Baseline to Week 12 in Weekly Mean of the 24-Hour Average Pain Scores
timeFrame: Baseline, Week 12
measure: Change From Baseline to Week 13 Endpoint in Weekly Mean of the 24-Hour Average Pain Scores
timeFrame: Baseline, Week 13
Secondary outcomes:
measure: Patient's Global Impression - Improvement (PGI-I) at Week 13 Endpoint
timeFrame: Week 13
measure: Change From Baseline to Week 13 Endpoint in Roland-Morris Disability Questionnaire (RMDQ) Total Score
timeFrame: Baseline, Week 13
measure: Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean 24-Hour Night Pain Score
timeFrame: Baseline, Week 13
measure: Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean of Worst Pain Score
timeFrame: Baseline, Week 13
measure: Change From Baseline to Week 13 Endpoint in Clinical Global Impression of Severity
timeFrame: Baseline, Week 13
measure: Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Worst Pain Score
timeFrame: Baseline, Week 13
measure: Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Least Pain Score
timeFrame: Baseline, Week 13
measure: Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Average Pain Score
timeFrame: Baseline, Week 13
measure: Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Pain Right Now Score
timeFrame: Baseline, Week 13
measure: Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - General Activity
timeFrame: Baseline, Week 13
measure: Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Mood
timeFrame: Baseline, Week 13
measure: Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Walking Ability
timeFrame: Baseline, Week 13
measure: Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Normal Work
timeFrame: Baseline, Week 13
measure: Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Relations With Other People
timeFrame: Baseline, Week 13
measure: Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Sleep
timeFrame: Baseline, Week 13
measure: Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Enjoyment of Life
timeFrame: Baseline, Week 13
measure: Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Average Interference
timeFrame: Baseline, Week 13
measure: Response to Treatment, as Defined by a 30% Reduction of Weekly Mean Score in 24-hour Average Pain Severity Ratings, Last Observation Carried Forward
timeFrame: Baseline to Week 13
measure: Response to Treatment, as Defined by a 50% Reduction of Weekly Mean Score in 24-hour Average Pain Severity Ratings, Last Observation Carried Forward
timeFrame: Baseline to Week 13
measure: Change From Baseline to Week 13 Endpoint in Athens Insomnia Scale
timeFrame: Baseline, Week 13
measure: Change From Baseline to Week 13 Endpoint in the 36-item Short-Form Health Survey (SF36)- Mental Component Summary (MCS)
timeFrame: Baseline, Week 13
measure: Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Component Summary (PCS)
timeFrame: Baseline, Week 13
measure: Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Bodily Pain
timeFrame: Baseline, Week 13
measure: Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - General Health
timeFrame: Baseline, Week 13
measure: Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Mental Health
timeFrame: Baseline, Week 13
measure: Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Functioning
timeFrame: Baseline, Week 13
measure: Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Emotional
timeFrame: Baseline, Week 13
measure: Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Physical
timeFrame: Baseline, Week 13
measure: Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Social Functioning
timeFrame: Baseline, Week 13
measure: Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Vitality
timeFrame: Baseline, Week 13
measure: Change From Baseline to Week 13 Endpoint in the Euro-Quality of Life Questionnaire - 5 Dimension - US Based Index Score
timeFrame: Baseline, Week 13
measure: Change From Baseline to Week 13 Endpoint in Beck Depression Inventory-II Total Score
timeFrame: Baseline, Week 13
measure: Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale
timeFrame: Baseline, Week 13
measure: Adverse Events Reported as Reason for Discontinuation
timeFrame: Baseline to Week 13
measure: Change From Baseline to Week 13 Endpoint in Laboratory Assessments - Alkaline Phosphatase
timeFrame: Baseline, Week 13
measure: Change From Baseline to 13 Week Endpoint in Laboratory Assessments - Alanine Transaminase
timeFrame: Baseline, Week 13
measure: Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bicarbonate, HCO3
timeFrame: Baseline, Week 13
measure: Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Direct
timeFrame: Baseline, Week 13
measure: Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Total
timeFrame: Baseline, Week 13
measure: Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Chloride
timeFrame: Baseline, Week 13
measure: Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Cholesterol
timeFrame: Baseline, Week 13
measure: Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Creatinine
timeFrame: Baseline, Week 13
measure: Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Potassium
timeFrame: Baseline, Week 13
measure: Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Uric Acid
timeFrame: Baseline, Week 13
measure: Change From Baseline to Week 13 Endpoint in Vital Signs - Pulse Rate
timeFrame: Baseline, Week 13
measure: Change From Baseline to Week 13 Endpoint in Vital Signs - Systolic Blood Pressure
timeFrame: Baseline, Week 13
measure: Change From Baseline to Week 13 Endpoint in Vital Signs - Diastolic Blood Pressure
timeFrame: Baseline, Week 13
measure: Change From Baseline to Week 13 Endpoint in Vital Signs - Weight
timeFrame: Baseline, Week 13
Other outcomes:
Locations:
city: Fort Myers
country: United States
facility: 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
state: Florida
city: Orlando
country: United States
facility: 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
state: Florida
city: South Miami
country: United States
facility: 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
state: Florida
city: Tampa
country: United States
facility: 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
state: Florida
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: Williamson OD, Schroer M, Ruff DD, Ahl J, Margherita A, Sagman D, Wohlreich MM. Onset of response with duloxetine treatment in patients with osteoarthritis knee pain and chronic low back pain: a post hoc analysis of placebo-controlled trials. Clin Ther. 2014 Apr 1;36(4):544-51. doi: 10.1016/j.clinthera.2014.02.009. Epub 2014 Mar 17.