Duloxetine Versus Placebo in Chronic Low Back Pain

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00408876
First received: December 6, 2006
Last updated: November 19, 2009
Last verified: November 2009
  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 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: Protocol F1J-MC-HMEO Duloxetine Versus Placebo in the Treatment of 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 1 in Weekly Mean of the 24-hour Average Pain Scores [ Time Frame: Baseline, Week 1 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 2 in Weekly Mean of the 24-Hour Average Pain Scores [ Time Frame: Baseline, Week 2 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 3 in Weekly Mean of the 24-Hour Average Pain Scores [ Time Frame: Baseline, Week 3 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 4 in Weekly Mean of the 24-Hour Average Pain Scores [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 5 in Weekly Mean of the 24-Hour Average Pain Scores [ Time Frame: Baseline, Week 5 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 6 in Weekly Mean of the 24-Hour Average Pain Scores [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 7 in Weekly Mean of the 24-Hour Average Pain Scores [ Time Frame: Baseline, Week 7 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 8 in Weekly Mean of the 24-Hour Average Pain Scores [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 9 in Weekly Mean of the 24-Hour Average Pain Scores [ Time Frame: Baseline, Week 9 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 10 in Weekly Mean of the 24-Hour Average Pain Scores [ Time Frame: Baseline, Week 10 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 11 in Weekly Mean of the 24-Hour Average Pain Scores [ Time Frame: Baseline, Week 11 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 12 in Weekly Mean of the 24-Hour Average Pain Scores [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 13 Endpoint in Weekly Mean of the 24-Hour Average Pain Scores [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient's Global Impression - Improvement (PGI-I) at Week 13 Endpoint [ Time Frame: Week 13 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 13 Endpoint in Roland-Morris Disability Questionnaire (RMDQ) Total Score [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean 24-Hour Night Pain Score [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean of Worst Pain Score [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 13 Endpoint in Clinical Global Impression of Severity [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Worst Pain Score [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Least Pain Score [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Average Pain Score [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Pain Right Now Score [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - General Activity [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Mood [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Walking Ability [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Normal Work [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Relations With Other People [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Sleep [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Enjoyment of Life [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Average Interference [ Time Frame: Baseline, Week 13 ] [ 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, Last Observation Carried Forward [ Time Frame: Baseline to Week 13 ] [ 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, Last Observation Carried Forward [ Time Frame: Baseline to Week 13 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 13 Endpoint in Athens Insomnia Scale [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 13 Endpoint in the 36-item Short-Form Health Survey (SF36)- Mental Component Summary (MCS) [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Component Summary (PCS) [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Bodily Pain [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - General Health [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Mental Health [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Functioning [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Emotional [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Physical [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Social Functioning [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Vitality [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 13 Endpoint in the Euro-Quality of Life Questionnaire - 5 Dimension - US Based Index Score [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 13 Endpoint in Beck Depression Inventory-II Total Score [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
  • Adverse Events Reported as Reason for Discontinuation [ Time Frame: Baseline to Week 13 ] [ Designated as safety issue: Yes ]
  • Change From Baseline to Week 13 Endpoint in Laboratory Assessments - Alkaline Phosphatase [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: Yes ]
  • Change From Baseline to 13 Week Endpoint in Laboratory Assessments - Alanine Transaminase [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: Yes ]
  • Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bicarbonate, HCO3 [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: Yes ]
  • Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Direct [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: Yes ]
  • Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Total [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: Yes ]
  • Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Chloride [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: Yes ]
  • Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Cholesterol [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: Yes ]
  • Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Creatinine [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: Yes ]
  • Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Potassium [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: Yes ]
  • Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Uric Acid [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: Yes ]
  • Change From Baseline to Week 13 Endpoint in Vital Signs - Pulse Rate [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: Yes ]
  • Change From Baseline to Week 13 Endpoint in Vital Signs - Systolic Blood Pressure [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: Yes ]
  • Change From Baseline to Week 13 Endpoint in Vital Signs - Diastolic Blood Pressure [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: Yes ]
  • Change From Baseline to Week 13 Endpoint in Vital Signs - Weight [ Time Frame: Baseline, Week 13 ] [ 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
Experimental: Duloxetine 20 mg
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
Drug: Duloxetine
Other Names:
  • LY248686
  • Cymbalta
Experimental: Duloxetine 60 mg
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
Drug: Duloxetine
Other Names:
  • LY248686
  • Cymbalta
Experimental: Duloxetine 120 mg
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
Drug: Duloxetine
Other Names:
  • LY248686
  • Cymbalta
Placebo Comparator: Placebo
placebo once a day (QD), by mouth (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 body mass index (BMI) over 40. - Have major depressive disorder. - Require daily narcotics.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 ph
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 ph
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 ph
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 ph
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 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: NCT00408876     History of Changes
Other Study ID Numbers: 10545, F1J-MC-HMEO
Study First Received: December 6, 2006
Results First Received: November 7, 2008
Last Updated: November 19, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Duloxetine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics
Antidepressive Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014