Phase 3
Completed N=404
Duloxetine Versus Placebo in Chronic Low Back Pain
Back Pain Without Radiation
Source: ClinicalTrials.gov NCT00408876 ↗
Enrolled (actual)
404
Serious AEs
2.0%
Results posted
Dec 2009
Primary outcomePrimary: Change From Baseline to Week 1 in Weekly Mean of the 24-hour Average Pain Scores — -0.54; -0.53; -0.71; -0.39 units on a scale — p=0.503
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 1 in Weekly Mean of the 24-hour Average Pain Scores |
-0.54; -0.53; -0.71; -0.39 | 0.503 |
| PRIMARY Change From Baseline to Week 2 in Weekly Mean of the 24-Hour Average Pain Scores |
-0.84; -0.91; -1.22; -0.75 | 0.756 |
| PRIMARY Change From Baseline to Week 3 in Weekly Mean of the 24-Hour Average Pain Scores |
-1.05; -1.58; -1.71; -1.01 | 0.885 |
| PRIMARY Change From Baseline to Week 4 in Weekly Mean of the 24-Hour Average Pain Scores |
-1.20; -1.70; -2.17; -1.02 | 0.575 |
| PRIMARY Change From Baseline to Week 5 in Weekly Mean of the 24-Hour Average Pain Scores |
-1.45; -1.94; -2.25; -1.26 | 0.516 |
| PRIMARY Change From Baseline to Week 6 in Weekly Mean of the 24-Hour Average Pain Scores |
-1.64; -2.10; -2.28; -1.34 | 0.309 |
| PRIMARY Change From Baseline to Week 7 in Weekly Mean of the 24-Hour Average Pain Scores |
-1.68; -2.17; -2.36; -1.57 | 0.709 |
| PRIMARY Change From Baseline to Week 8 in Weekly Mean of the 24-Hour Average Pain Scores |
-1.68; -2.29; -2.49; -1.65 | 0.931 |
| PRIMARY Change From Baseline to Week 9 in Weekly Mean of the 24-Hour Average Pain Scores |
-1.57; -2.21; -2.45; -1.71 | 0.634 |
| PRIMARY Change From Baseline to Week 10 in Weekly Mean of the 24-Hour Average Pain Scores |
-1.77; -2.24; -2.58; -1.73 | 0.910 |
| PRIMARY Change From Baseline to Week 11 in Weekly Mean of the 24-Hour Average Pain Scores |
-1.88; -2.32; -2.62; -1.79 | 0.733 |
| PRIMARY Change From Baseline to Week 12 in Weekly Mean of the 24-Hour Average Pain Scores |
-1.87; -2.34; -2.46; -1.91 | 0.890 |
| PRIMARY Change From Baseline to Week 13 Endpoint in Weekly Mean of the 24-Hour Average Pain Scores |
-1.74; -2.50; -2.42; -2.10 | 0.243 |
| SECONDARY Patient's Global Impression - Improvement (PGI-I) at Week 13 Endpoint |
2.72; 2.44; 2.66; 2.93 | 0.318 |
| SECONDARY Change From Baseline to Week 13 Endpoint in Roland-Morris Disability Questionnaire (RMDQ) Total Score |
-2.29; -2.74; -2.88; -1.33 | 0.161 |
| SECONDARY Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean 24-Hour Night Pain Score |
-1.77; -2.15; -2.47; -1.91 | 0.657 |
| SECONDARY Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean of Worst Pain Score |
-1.77; -2.46; -2.40; -2.10 | 0.365 |
| SECONDARY Change From Baseline to Week 13 Endpoint in Clinical Global Impression of Severity |
-0.53; -0.94; -1.06; -0.53 | 0.984 |
| SECONDARY Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Worst Pain Score |
-1.78; -2.77; -2.78; -2.09 | 0.464 |
| SECONDARY Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Least Pain Score |
-1.30; -2.06; -2.16; -1.51 | 0.543 |
| SECONDARY Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Average Pain Score |
-1.79; -2.50; -2.45; -1.87 | 0.813 |
| SECONDARY Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Pain Right Now Score |
-1.63; -2.67; -2.61; -1.74 | 0.790 |
| SECONDARY Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - General Activity |
-1.99; -2.52; -2.36; -1.97 | 0.948 |
| SECONDARY Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Mood |
-1.75; -2.52; -1.96; -1.70 | 0.887 |
| SECONDARY Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Walking Ability |
-1.79; -2.33; -1.89; -1.43 | 0.374 |
| SECONDARY Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Normal Work |
-2.20; -2.67; -2.38; -1.95 | 0.556 |
| SECONDARY Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Relations With Other People |
-1.33; -1.86; -1.27; -0.94 | 0.234 |
| SECONDARY Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Sleep |
-1.59; -2.48; -2.12; -1.63 | 0.925 |
| SECONDARY Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Enjoyment of Life |
-1.84; -2.49; -1.86; -1.76 | 0.849 |
| SECONDARY Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Average Interference |
-1.84; -2.40; -1.92; -1.61 | 0.465 |
| 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 |
23; 59; 63; 49 | 0.869 |
| 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 |
12; 38; 40; 33 | 0.356 |
| SECONDARY Change From Baseline to Week 13 Endpoint in Athens Insomnia Scale |
-1.43; -2.30; -0.93; -1.23 | 0.747 |
| SECONDARY Change From Baseline to Week 13 Endpoint in the 36-item Short-Form Health Survey (SF36)- Mental Component Summary (MCS) |
0.01; 0.57; -1.26; -0.45 | 0.729 |
| SECONDARY Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Component Summary (PCS) |
6.07; 7.01; 7.85; 6.11 | 0.977 |
| SECONDARY Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Bodily Pain |
1.51; 1.95; 2.11; 1.36 | 0.645 |
| SECONDARY Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - General Health |
0.70; 1.24; 0.81; 0.66 | 0.929 |
| SECONDARY Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Mental Health |
0.21; 0.98; 0.46; 0.38 | 0.766 |
| SECONDARY Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Functioning |
1.80; 2.55; 3.11; 2.23 | 0.501 |
| SECONDARY Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Emotional |
0.10; 0.19; 0.14; 0.08 | 0.862 |
| SECONDARY Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Physical |
0.81; 0.80; 0.85; 0.80 | 0.972 |
| SECONDARY Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Social Functioning |
0.75; 0.46; 0.38; 0.50 | 0.340 |
| SECONDARY Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Vitality |
0.69; 1.43; 0.44; 0.91 | 0.713 |
| SECONDARY Change From Baseline to Week 13 Endpoint in the Euro-Quality of Life Questionnaire - 5 Dimension - US Based Index Score |
0.04; 0.07; 0.08; 0.05 | 0.663 |
| SECONDARY Change From Baseline to Week 13 Endpoint in Beck Depression Inventory-II Total Score |
-1.24; -1.54; 0.37; -1.02 | 0.786 |
| SECONDARY Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale |
-0.30; -0.81; -0.91; -0.68 | 0.378 |
| SECONDARY Adverse Events Reported as Reason for Discontinuation |
9; 17; 27; 10; 1; 1 | — |
| SECONDARY Change From Baseline to Week 13 Endpoint in Laboratory Assessments - Alkaline Phosphatase |
-1.19; 3.27; 1.11; -1.43 | <0.001 sig |
| SECONDARY Change From Baseline to 13 Week Endpoint in Laboratory Assessments - Alanine Transaminase |
-1.39; 0.25; 2.20; -0.06 | 0.039 sig |
| SECONDARY Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bicarbonate, HCO3 |
1.04; 1.18; 1.72; 1.35 | 0.048 sig |
| SECONDARY Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Direct |
-0.29; -0.13; -0.13; 0.07 | 0.015 sig |
| SECONDARY Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Total |
-1.05; -0.23; -0.58; 0.18 | 0.039 sig |
| SECONDARY Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Chloride |
-0.22; -0.54; -0.99; -0.47 | 0.042 sig |
| SECONDARY Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Cholesterol |
-0.04; -0.09; 0.01; -0.22 | <0.001 sig |
| SECONDARY Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Creatinine |
-11.43; -0.66; 1.34; 2.02 | 0.031 sig |
| SECONDARY Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Potassium |
-0.02; 0.00; 0.06; -0.08 | 0.030 sig |
| SECONDARY Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Uric Acid |
-9.48; -11.08; -11.31; 8.20 | 0.005 sig |
| SECONDARY Change From Baseline to Week 13 Endpoint in Vital Signs - Pulse Rate |
-1.10; 2.79; 1.90; 0.29 | 0.348 |
| SECONDARY Change From Baseline to Week 13 Endpoint in Vital Signs - Systolic Blood Pressure |
-0.64; -1.18; 1.00; -1.04 | 0.846 |
| SECONDARY Change From Baseline to Week 13 Endpoint in Vital Signs - Diastolic Blood Pressure |
-0.51; -0.79; 2.94; -0.68 | 0.901 |
| SECONDARY Change From Baseline to Week 13 Endpoint in Vital Signs - Weight |
-0.59; -0.35; -0.72; 0.10 | 0.057 |
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.
Data sourced from ClinicalTrials.gov (NCT00408876). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.