Duloxetine Versus Placebo in Chronic Low Back Pain
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00424593
First received: January 17, 2007
Last updated: November 18, 2009
Last verified: November 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Back Pain Without Radiation |
Drug: Duloxetine Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effect of Duloxetine 60 mg to 120 mg Once Daily in Patients With Chronic Low Back Pain |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Change From Baseline to Week 13 in Brief Pain Inventory (BPI), 24-hour Average Pain Scores [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Patient's Global Impression of Improvement (PGI-I) [ Time Frame: Week 13 ] [ Designated as safety issue: No ]
- Change From Baseline to Week 13 and Week 54 Endpoints in Roland Morris Disability Questionnaire-24 Item (RMDQ-24) Total Score [ Time Frame: Baseline, Week 13, Week 54 ] [ Designated as safety issue: No ]
- 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 [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
- Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores [ Time Frame: Baseline, Week 13, Week 54 ] [ Designated as safety issue: No ]
- Change From Baseline to Week 13 and Week 54 Endpoints in Clinical Global Impression of Severity (CGI-Severity) [ Time Frame: Baseline, Week 13, Week 54 ] [ Designated as safety issue: No ]
- Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 30% Score Reduction Criteria [ Time Frame: Week 13 ] [ Designated as safety issue: No ]
- Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 50% Score Reduction Criteria [ Time Frame: Week 13 ] [ Designated as safety issue: No ]
- Change From Baseline to Week 13 and Week 54 Endpoints in Athens Insomnia Scale [ Time Frame: Baseline, Week 13, Week 54 ] [ Designated as safety issue: No ]
- Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36) [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
- Change From Baseline to Week 13 Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D) [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
- Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores [ Time Frame: Baseline, Week 13, Week 54 ] [ Designated as safety issue: No ]
- Change From Baseline to Week 13 and Week 54 Endpoints in Beck Depression Inventory (BDI-II) Total Scores [ Time Frame: Baseline, Week 13, Week 54 ] [ Designated as safety issue: No ]
- Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Scores [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
- Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Bicarbonate [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: Yes ]
- Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Uric Acid [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: Yes ]
- Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Pulse Rate [ Time Frame: Baseline, Week 13, Week 54 ] [ Designated as safety issue: Yes ]
- Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure [ Time Frame: Baseline, Week 13, Week 54 ] [ Designated as safety issue: Yes ]
- Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Weight [ Time Frame: Baseline, Week 13, Week 54 ] [ Designated as safety issue: Yes ]
| Enrollment: | 236 |
| Study Start Date: | January 2007 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Duloxetine
30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
|
Drug: Duloxetine
30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
Other Names:
|
|
Placebo Comparator: Placebo
every day (QD), by mouth (PO), 13 weeks
|
Drug: Placebo
every day (QD), by mouth (PO), 13 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00424593
Locations
| Brazil | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p | |
| Curitiba, Brazil, 80060240 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p | |
| San Paulo, Brazil, 04027-000 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p | |
| Sao Paulo, Brazil, 04026-000 | |
| France | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p | |
| Amiens, France, 80054 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p | |
| Marseille, France, 13008 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p | |
| Paris, France, 75014 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p | |
| Saint Affrique, France, 12400 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p | |
| Saint-Etienne, France, 42055 | |
| Germany | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p | |
| Ellwangen, Germany, 73479 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p | |
| Graefelfing, Germany, 82166 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p | |
| Hamburg, Germany, 22143 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p | |
| Wiesbaden, Germany, 65191 | |
| Mexico | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p | |
| Mexico City, Mexico, 06700 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p | |
| Monterrey, Mexico, 64460 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p | |
| San Pedro Garza Garcia, Mexico, 66260 | |
| Netherlands | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p | |
| Amsterdam, Netherlands, 1105 AZ | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p | |
| Rotterdam, Netherlands, 3039 BD | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
More Information
Additional Information:
No publications provided by Eli Lilly and Company
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Chief Medical Officer, Eli Lilly |
| ClinicalTrials.gov Identifier: | NCT00424593 History of Changes |
| Other Study ID Numbers: | 10544, F1J-MC-HMEN |
| Study First Received: | January 17, 2007 |
| Results First Received: | October 16, 2009 |
| Last Updated: | November 18, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Back Pain Low Back Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Duloxetine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Adrenergic Uptake Inhibitors Adrenergic Agents Dopamine Uptake Inhibitors Dopamine Agents Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013