CompletedPhase 3

Duloxetine Versus Placebo in Chronic Low Back Pain

Brazil, France, Germany236 participantsStarted 2007-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change From Baseline to Week 13 in Brief Pain Inventory (BPI), 24-hour Average Pain Scores

Timeframe: Baseline, Week 13

Trial details

NCT IDNCT00424593

SponsorEli Lilly and Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-12

Results submitted2009-10-16

View on ClinicalTrials.gov More Back Pain Without Radiation trials