Duloxetine vs. Placebo in Chronic Low Back Pain - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00408876

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.

Condition	Intervention	Phase
Back Pain Without Radiation	Drug: Duloxetine Drug: Placebo	Phase III

MedlinePlus related topics: Back Pain

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Protocol F1J-MC-HMEO Duloxetine Versus Placebo in the Treatment of Chronic Low Back Pain

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Weekly mean of the BPI 24-hour average pain item [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient's Global Impression - Improvement (PGI-I), 60 mg [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
Roland-Morris Disability Questionnaire, 60 mg [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
11-point Likert scale, 24 hour average pain, 20 mg, 120 mg [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
Patient's Global Impression - Improvement (PGI-I), 20 mg, 120 mg [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
Roland-Morris Disability Questionnaire, 20 mg, 120 mg [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
11-point Likert scale, weekly mean of night pain and worst pain [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
Brief Pain Inventory - Severity and Interference [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
Clinical Global Impression of Severity [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
Response to treatment, as defined by a 30% reduction of weekly mean score in 24-hour average pain severity ratings [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
Response to treatment, as defined by a 50% reduction of weekly mean score in 24-hour average pain severity ratings [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
Athens Insomnia Scale [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
36-item Short-Form Health Survey (SF36) [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
EuroQoL Questionnaire - 5 Dimension [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
Beck Depression Inventory-II [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
Hospital Anxiety and Depression Scale (HADS) anxiety subscale [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
Discontinuation rates [ Time Frame: over 13 weeks ] [ Designated as safety issue: Yes ]
Treatment-emergent adverse events [ Time Frame: over 13 weeks ] [ Designated as safety issue: Yes ]
Laboratory assessments [ Time Frame: over 13 weeks ] [ Designated as safety issue: Yes ]
Vital signs [ Time Frame: over 13 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	404
Study Start Date:	December 2006
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental duloxetine 20mg QD, PO for 13 weeks	Drug: Duloxetine
B: Experimental duloxetine 30 mg QD, PO for 1 week then duloxetine 60mg QD, PO for 12 weeks	Drug: Duloxetine
C: Experimental duloxetine 30 mg QD, PO for 1 week followed by duloxetine 60mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks	Drug: Duloxetine
D: Placebo Comparator placebo QD, PO for 13 weeks	Drug: Placebo

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.

Exclusion Criteria:

You have a serious or unstable disease 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, or 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 BMI over 40.
Have major depressive disorder.
Require daily narcotics.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00408876

Locations

United States, Florida
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 personal physician.
Fort Myers, Florida, United States, 33912
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 personal physician.
Orlando, Florida, United States, 32806
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 personal physician.
South Miami, Florida, United States, 33143
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 personal physician.
Tampa, Florida, United States, 33606

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

No publications provided

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	10545, F1J-MC-HMEO
Study First Received:	December 6, 2006
Last Updated:	September 26, 2008
ClinicalTrials.gov Identifier:	NCT00408876 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Adrenergic Agents
Psychotropic Drugs
Low Back Pain
Pain
Back Pain
Serotonin Uptake Inhibitors

Duloxetine
Serotonin
Signs and Symptoms
Dopamine
Neurologic Manifestations
Dopamine Agents
Antidepressive Agents

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Nervous System Diseases
Psychotropic Drugs
Low Back Pain
Pain

Back Pain
Serotonin Uptake Inhibitors
Duloxetine
Pharmacologic Actions
Signs and Symptoms
Serotonin Agents
Therapeutic Uses
Neurologic Manifestations
Dopamine Agents
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on May 07, 2009