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Duloxetine Versus Placebo in Chronic Low Back Pain

This study has been completed.
Sponsor:
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
  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:
  • LY248686
  • Cymbalta
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
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: 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
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 November 20, 2014