Phase 3
N=401
A Study for Patient With Chronic Low Back Pain
Chronic Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT00767806 ↗Enrolled (actual)
401
Serious AEs
1.3%
Results posted
Oct 2010
Primary outcome: Primary: Change From Baseline to 12 Weeks in Brief Pain Inventory 24-hour Average Pain Score — -2.48; -1.80 units on a scale — p=0.001
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
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to 12 Weeks in Brief Pain Inventory 24-hour Average Pain Score |
-2.48; -1.80 | 0.001 sig |
| SECONDARY Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) |
7.26; 7.06; -2.75; -1.99; 4.11; 4.04 | 0.002 sig |
| SECONDARY Change From Baseline to 12 Weeks in Weekly Mean of 24-hour Average Pain, Worst Pain, and Night Pain Rating |
-2.14; -1.43; -2.19; -1.48; -1.62; -1.10 | <0.001 sig |
| SECONDARY Number of Responders: 30 Percent (%) or Greater Reduction of the Brief Pain Inventory (BPI) Average Pain Severity Rating at 12 Week Endpoint |
111; 97 | 0.108 |
| SECONDARY Number of Responders: 50 Percent (%) or Greater Reduction of the Brief Pain Inventory (BPI) Average Pain Severity Rating at 12 Week Endpoint |
95; 69 | 0.006 sig |
| SECONDARY Number of Sustained Responders at 12 Week Endpoint |
89; 73 | 0.082 |
| SECONDARY Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution |
12; 15; 62; 67; 124; 121 | 0.013 sig |
| SECONDARY Change From Baseline to 12 Weeks Endpoint in Clinical Global Impressions of Severity (CGI-S) |
-0.95; -0.79 | 0.077 |
| SECONDARY Patient's Global Impression of Improvement (PGI-I) at 12 Weeks |
2.88; 3.19 | 0.011 sig |
| SECONDARY Change From Baseline to 12 Weeks in Roland Morris Disability Questionnaire |
-2.69; -2.22 | 0.255 |
| SECONDARY Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form |
4.22; 4.29; -1.58; -0.78; 2.67; 2.74 | <0.001 sig |
| SECONDARY Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey |
34.41; 34.29; 6.15; 5.22; 49.50; 49.59 | 0.168 |
| SECONDARY Change From Baseline to 12 Weeks in European Quality of Life Questionnaire - 5 Dimension |
0.52; 0.57; 0.19; 0.07; 0.66; 0.69 | <0.001 sig |
| SECONDARY Change From Baseline to 12 Weeks in Work Productivity and Activity Impairment Instrument (WPAI) |
0.08; 0.10; -0.03; -0.03; 0.49; 0.48 | 0.461 |
| SECONDARY Participants Who Discontinued From Baseline to 12 Weeks |
51; 47 | — |
| SECONDARY Change From Baseline to 12 Weeks in Uric Acid |
-14.06; 1.34 | 0.010 sig |
| SECONDARY Change From Baseline to 12 Week Endpoint in Albumin |
-0.76; -0.12 | 0.031 sig |
| SECONDARY Change From Baseline to 12 Week Endpoint in Alkaline Phosphatase |
1.59; -1.85 | 0.004 sig |
| SECONDARY Change From Baseline to 12 Week Endpoint in Alanine Aminotransferase |
1.51; -1.71 | 0.013 sig |
| SECONDARY Change From Baseline to 12 Week Endpoint in Aspartate Aminotransferase |
1.90; -0.54 | 0.039 sig |
| SECONDARY Change From Baseline to 12 Week Endpoint in Creatinine |
-1.69; 0.70 | 0.024 sig |
| SECONDARY Change From Baseline to 12 Week Endpoint in Total Protein |
-1.34; -0.43 | 0.019 sig |
| SECONDARY Change From Baseline to 12 Weeks in Blood Pressure |
0.49; -0.59; -0.14; -0.64 | 0.329 |
| SECONDARY Change From Baseline to 12 Week Endpoint in Weight |
-0.31; 0.05 | — |
| SECONDARY Change From Baseline to 12 Week Endpoint in Pulse Rate |
0.18; -0.17 | 0.680 |
| SECONDARY Number of Participants With Suicidal Ideation or Suicidal Behaviors According to the Columbia Suicide Severity Rating Scale |
0; 0 | — |
Summary
The purpose of this study is to determine if duloxetine reduces the severity of chronic low back pain.
Eligibility Criteria
Inclusion Criteria
- Male or female outpatients with chronic low back pain
Exclusion Criteria
- Cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study.
- Acute liver injury (such as hepatitis) or severe cirrhosis.
- Previous exposure to duloxetine.
- Body Mass Index (BMI) over 40.
- Major depressive disorder.
- Daily use of narcotics.
Data sourced from ClinicalTrials.gov (NCT00767806). 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.