Phase 3
N=236
Duloxetine Versus Placebo in Chronic Low Back Pain
Back Pain Without Radiation
Bottom Line
View on ClinicalTrials.gov: NCT00424593 ↗Enrolled (actual)
236
Serious AEs
2.5%
Results posted
Nov 2009
Primary outcome: Primary: Change From Baseline to Week 13 in Brief Pain Inventory (BPI), 24-hour Average Pain Scores — -2.32; -1.50 units on a scale — p=0.004
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Duloxetine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Dec 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 13 in Brief Pain Inventory (BPI), 24-hour Average Pain Scores |
-2.32; -1.50 | 0.004 sig |
| SECONDARY Patient's Global Impression of Improvement (PGI-I) |
2.81; 3.23 | 0.014 sig |
| SECONDARY Change From Baseline to Week 13 and Week 54 Endpoints in Roland Morris Disability Questionnaire-24 Item (RMDQ-24) Total Score |
10.39; 10.87; -3.13; -1.53; 7.83; 9.59 | 0.009 sig |
| SECONDARY Change From Baseline to Week 13 Endpoint in Weekly Mean of 24-hour Average Pain, Night Pain and Worst Pain by 11-Point Likert Scale |
5.94; 6.05; -1.92; -1.16; 6.91; 7.02 | 0.002 sig |
| SECONDARY Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores |
7.43; 7.34; -2.55; -1.72; 4.49; 5.67 | 0.011 sig |
| SECONDARY Change From Baseline to Week 13 and Week 54 Endpoints in Clinical Global Impression of Severity (CGI-Severity) |
3.23; 3.27; -0.94; -0.74; 2.21; 2.60 | 0.092 |
| SECONDARY Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 30% Score Reduction Criteria |
58; 46 | 0.060 |
| SECONDARY Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 50% Score Reduction Criteria |
42; 31 | 0.087 |
| SECONDARY Change From Baseline to Week 13 and Week 54 Endpoints in Athens Insomnia Scale |
8.03; 8.29; -2.01; -1.50; 5.42; 6.70 | 0.329 |
| SECONDARY Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36) |
49.69; 49.60; 2.05; -0.49; 33.39; 32.62 | 0.051 |
| SECONDARY Change From Baseline to Week 13 Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D) |
0.49; 0.49; 0.16; 0.11 | 0.117 |
| SECONDARY Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores |
0.17; 0.05; -0.14; 0.03; 0.03; 0.02 | 0.063 |
| SECONDARY Change From Baseline to Week 13 and Week 54 Endpoints in Beck Depression Inventory (BDI-II) Total Scores |
6.94; 6.81; -0.51; 0.68; 5.93; 7.69 | 0.177 |
| SECONDARY Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Scores |
4.94; 4.41; -0.70; 0.11; 3.65; 3.87 | 0.122 |
| SECONDARY Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Bicarbonate |
24.90; 25.10; 0.57; -0.28 | 0.046 sig |
| SECONDARY Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Uric Acid |
303.23; 298.07; -6.27; 8.68 | 0.008 sig |
| SECONDARY Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Pulse Rate |
72.21; 72.31; 2.05; -0.90; 74.95; 71.03 | 0.028 sig |
| SECONDARY Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure |
127.44; 127.62; -0.94; -1.24; 127.04; 127.07 | 0.764 |
| SECONDARY Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Weight |
76.63; 76.29; -0.64; 0.08; 76.57; 75.34 | 0.008 sig |
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.
Patients who do not have their pain reduced by at least 30% by week 7 will be given 120 mg dose for the duration of the study. After the 13 week double blind period, patients randomized to placebo will switch to duloxetine 60 mg or 120 mg in the 41-week extension period.
Eligibility Criteria
Inclusion Criteria
- Male/Female outpatients 18 years of age with chronic low back pain
- Females of child bearing potential must test negative on a pregnancy test at visit 1.
Exclusion Criteria
- Have a serious or unstable diseases 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
- 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 a major depressive disorder
- Require daily narcotics
- Have suicidal risk
- Have a presence of any factors/conditions, medical or other, that in the judgment of the investigator may interfere with performance of study outcome measures
Data sourced from ClinicalTrials.gov (NCT00424593). 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.