Duloxetine Versus Placebo in Chronic Low Back Pain
CompletedPhase 3NCT00424593
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Effect of Duloxetine 60 mg to 120 mg Once Daily in Patients With Chronic Low Back Pain
- Conditions
- Back Pain Without Radiation
- Interventions
- Sponsor
- Eli Lilly and Company
- Start date
- 2007-01
- Primary completion
- 2007-12
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- Brazil, France, Germany, Mexico, Netherlands
- Total sites listed
- 17
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00424593