Duloxetine Versus Placebo in Chronic Low Back Pain

Back Pain Without Radiation Clinical Trial

Official title:

Effect of Duloxetine 60 mg to 120 mg Once Daily in Patients With Chronic Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00424593
• Other study ID #: 10544
• Secondary ID: F1J-MC-HMEN
• Status: Completed
• Phase: Phase 3
• First received: January 17, 2007
• Last updated: November 18, 2009
• Start date: January 2007
• Est. completion date: October 2008

Study information

• Verified date: November 2009
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: October 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Back Pain
• Back Pain Without Radiation
• Low Back Pain

Intervention

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
• Placebo
every day (QD), by mouth (PO), 13 weeks

Locations

Country	Name	City	State
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	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	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
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	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	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	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	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
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	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	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	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
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	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	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
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	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

Brazil,  France,  Germany,  Mexico,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Week 13 in Brief Pain Inventory (BPI), 24-hour Average Pain Scores		Baseline, Week 13	No
Secondary	Patient's Global Impression of Improvement (PGI-I)		Week 13	No
Secondary	Change From Baseline to Week 13 and Week 54 Endpoints in Roland Morris Disability Questionnaire-24 Item (RMDQ-24) Total Score		Baseline, Week 13, Week 54	No
Secondary	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		Baseline, Week 13	No
Secondary	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores		Baseline, Week 13, Week 54	No
Secondary	Change From Baseline to Week 13 and Week 54 Endpoints in Clinical Global Impression of Severity (CGI-Severity)		Baseline, Week 13, Week 54	No
Secondary	Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 30% Score Reduction Criteria		Week 13	No
Secondary	Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 50% Score Reduction Criteria		Week 13	No
Secondary	Change From Baseline to Week 13 and Week 54 Endpoints in Athens Insomnia Scale		Baseline, Week 13, Week 54	No
Secondary	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)		Baseline, Week 13	No
Secondary	Change From Baseline to Week 13 Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D)		Baseline, Week 13	No
Secondary	Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores		Baseline, Week 13, Week 54	No
Secondary	Change From Baseline to Week 13 and Week 54 Endpoints in Beck Depression Inventory (BDI-II) Total Scores		Baseline, Week 13, Week 54	No
Secondary	Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Scores		Baseline, Week 13	No
Secondary	Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Bicarbonate		Baseline, Week 13	Yes
Secondary	Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Uric Acid		Baseline, Week 13	Yes
Secondary	Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Pulse Rate		Baseline, Week 13, Week 54	Yes
Secondary	Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure		Baseline, Week 13, Week 54	Yes
Secondary	Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Weight		Baseline, Week 13, Week 54	Yes

External Links

•   Lilly Clinical Trial Registry