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A Study for Patient With Chronic Low Back Pain

Primary Purpose

Chronic Low Back Pain

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Duloxetine

Placebo

About this trial

This is an interventional treatment trial for Chronic Low Back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female outpatients with chronic low back pain

Exclusion Criteria:

Cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study.
Acute liver injury (such as hepatitis) or severe cirrhosis.
Previous exposure to duloxetine.
Body Mass Index (BMI) over 40.
Major depressive disorder.
Daily use of narcotics.

Sites / Locations

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Duloxetine

Placebo

Arm Description

Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment

Patients received placebo by mouth once daily for 12 weeks of double-blind treatment

Outcomes

Primary Outcome Measures

Change From Baseline to 12 Weeks in Brief Pain Inventory 24-hour Average Pain Score

A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least Squares Mean values were controlled for investigator and baseline severity.

Secondary Outcome Measures

Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I)

BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.

Change From Baseline to 12 Weeks in Weekly Mean of 24-hour Average Pain, Worst Pain, and Night Pain Rating

24-hour average pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Patients completed the electronic diary at bedtime. The 11-point Likert scale was also used for assessment of night pain and worst pain each day, and evaluated as weekly means. Least Squares Mean values were controlled for investigator and baseline severity.

Number of Responders: 30 Percent (%) or Greater Reduction of the Brief Pain Inventory (BPI) Average Pain Severity Rating at 12 Week Endpoint

Response to treatment was defined as at least a 30% reduction from baseline to endpoint (last observation carried forward) in the BPI average pain severity score. BPI is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Response was assessed at endpoint.

Number of Responders: 50 Percent (%) or Greater Reduction of the Brief Pain Inventory (BPI) Average Pain Severity Rating at 12 Week Endpoint

Response to treatment was defined as at least a 50% reduction from baseline to endpoint (last observation carried forward) in the BPI average pain severity score. BPI is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Response was assessed at endpoint.

Number of Sustained Responders at 12 Week Endpoint

Sustained responders: participants with ≥30% reduction of BPI average pain rating from baseline to endpoint and baseline to earlier visit than last visit and who maintain a ≥20% reduction of BPI average pain rating from baseline at every visit between last visit and earlier visit. BPI: a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Number of sustained responders was assessed at endpoint.

Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution

The results presented are the cumulative number of participants reaching each threshold of BPI average pain reduction. The thresholds are given as percent reductions in BPI average pain score from the baseline score. BPI: a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Number of participants under each threshold was assessed at endpoint.

Change From Baseline to 12 Weeks Endpoint in Clinical Global Impressions of Severity (CGI-S)

Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Least Squares Mean values were controlled for investigator and baseline severity.

Patient's Global Impression of Improvement (PGI-I) at 12 Weeks

A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Least Squares Mean values were controlled for investigator and baseline severity.

Change From Baseline to 12 Weeks in Roland Morris Disability Questionnaire

Roland-Morris questionnaire will be completed by the patient and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the patient is instructed to put a mark next to each appropriate statement. The number of statements marked will be added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability). Least Squares Mean values were controlled for investigator and baseline severity.

Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form

The 30-item BPOMS measures mood states and has 6 factors: tension-anxiety (Ten), depression-dejection (Dep), anxiety-hostility (Ang), fatigue (Fat), confusion (Con), and vigor (Vig). Item scores: 0 (not at all) to 4 (extremely). Each factor scores range from 0 to 20. The Total score is sum of all factor scores minus the factor score for vigor (Total=Ten+Dep+Ang+Fat+Con-Vig) and ranges from 0 (least disturbed) to 80 (most disturbed).

Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey

The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). The score for each of the domain and component summary=0-100 (higher scores indicate better health status or functioning).

Change From Baseline to 12 Weeks in European Quality of Life Questionnaire - 5 Dimension

Generic, multidimensional, health-related, quality-of-life instrument. The profile allows patients to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each patient, the outcome rating on 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1; higher scores indicate a better health state perceived by the patient. Participants were evaluated with the United Kingdom (UK) and the United States (US) population based index score.

Change From Baseline to 12 Weeks in Work Productivity and Activity Impairment Instrument (WPAI)

WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Absenteeism Presenteeism Work productivity loss Activity Impairment Scores range from 0 to 1 for each of the above 4 types; higher scores indicate greater impairment.

Participants Who Discontinued From Baseline to 12 Weeks

Reasons for discontinuation are listed in the participant flow.

Change From Baseline to 12 Weeks in Uric Acid

Least Squares Mean values were controlled for investigator.

Change From Baseline to 12 Week Endpoint in Albumin

Least Squares Mean values were controlled for investigator.

Change From Baseline to 12 Week Endpoint in Alkaline Phosphatase

Least Squares Mean values were controlled for investigator.

Change From Baseline to 12 Week Endpoint in Alanine Aminotransferase

Least Squares Mean values were controlled for investigator.

Change From Baseline to 12 Week Endpoint in Aspartate Aminotransferase

Least Squares Mean values were controlled for investigator.

Change From Baseline to 12 Week Endpoint in Creatinine

Least Squares Mean values were controlled for investigator.

Change From Baseline to 12 Week Endpoint in Total Protein

Least Squares Mean values were controlled for investigator.

Change From Baseline to 12 Weeks in Blood Pressure

Least Squares Mean values were controlled for investigator.

Change From Baseline to 12 Week Endpoint in Weight

Least Squares Mean values were controlled for investigator.

Change From Baseline to 12 Week Endpoint in Pulse Rate

Least Squares Mean values were controlled for investigator.

Number of Participants With Suicidal Ideation or Suicidal Behaviors According to the Columbia Suicide Severity Rating Scale

The Columbia Suicide Severity Rating Scale (C-SSRS) captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred.

Full Information

NCT ID

NCT00767806

First Posted

October 3, 2008

Last Updated

September 30, 2010

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00767806

Brief Title

A Study for Patient With Chronic Low Back Pain

Official Title

Effect of Duloxetine 60 mg Once Daily Versus Placebo in Patients With Chronic Low Back Pain

Study Type

Interventional

2. Study Status

Record Verification Date

September 2010

Overall Recruitment Status

Completed

Study Start Date

September 2008 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine if duloxetine reduces the severity of chronic low back pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Low Back Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

401 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Duloxetine

Arm Type

Experimental

Arm Description

Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Patients received placebo by mouth once daily for 12 weeks of double-blind treatment

Intervention Type

Drug

Intervention Name(s)

Duloxetine

Other Intervention Name(s)

Cymbalta, LY248686

Intervention Description

60 mg orally once daily for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo once daily orally for 12 weeks

Primary Outcome Measure Information:

Title

Change From Baseline to 12 Weeks in Brief Pain Inventory 24-hour Average Pain Score

Description

Time Frame

baseline, 12 weeks

Secondary Outcome Measure Information:

Title

Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I)

Description

Time Frame

baseline, 12 weeks

Title

Change From Baseline to 12 Weeks in Weekly Mean of 24-hour Average Pain, Worst Pain, and Night Pain Rating

Description

Time Frame

baseline, 12 weeks

Title

Number of Responders: 30 Percent (%) or Greater Reduction of the Brief Pain Inventory (BPI) Average Pain Severity Rating at 12 Week Endpoint

Description

Time Frame

12 weeks

Title

Number of Responders: 50 Percent (%) or Greater Reduction of the Brief Pain Inventory (BPI) Average Pain Severity Rating at 12 Week Endpoint

Description

Time Frame

12 weeks

Title

Number of Sustained Responders at 12 Week Endpoint

Description

Time Frame

12 weeks

Title

Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution

Description

Time Frame

12 weeks

Title

Change From Baseline to 12 Weeks Endpoint in Clinical Global Impressions of Severity (CGI-S)

Description

Time Frame

baseline, 12 weeks

Title

Patient's Global Impression of Improvement (PGI-I) at 12 Weeks

Description

Time Frame

12 weeks

Title

Change From Baseline to 12 Weeks in Roland Morris Disability Questionnaire

Description

Time Frame

baseline, 12 weeks

Title

Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form

Description

Time Frame

baseline, 12 weeks

Title

Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey

Description

Time Frame

baseline, 12 weeks

Title

Change From Baseline to 12 Weeks in European Quality of Life Questionnaire - 5 Dimension

Description

Time Frame

baseline, 12 weeks

Title

Change From Baseline to 12 Weeks in Work Productivity and Activity Impairment Instrument (WPAI)

Description

Time Frame

baseline, 12 weeks

Title

Participants Who Discontinued From Baseline to 12 Weeks

Description

Reasons for discontinuation are listed in the participant flow.

Time Frame

baseline, 12 weeks

Title

Change From Baseline to 12 Weeks in Uric Acid

Description

Least Squares Mean values were controlled for investigator.

Time Frame

baseline, 12 weeks

Title

Change From Baseline to 12 Week Endpoint in Albumin

Description

Least Squares Mean values were controlled for investigator.

Time Frame

baseline, 12 weeks

Title

Change From Baseline to 12 Week Endpoint in Alkaline Phosphatase

Description

Least Squares Mean values were controlled for investigator.

Time Frame

baseline, 12 weeks

Title

Change From Baseline to 12 Week Endpoint in Alanine Aminotransferase

Description

Least Squares Mean values were controlled for investigator.

Time Frame

baseline, 12 weeks

Title

Change From Baseline to 12 Week Endpoint in Aspartate Aminotransferase

Description

Least Squares Mean values were controlled for investigator.

Time Frame

baseline, 12 weeks

Title

Change From Baseline to 12 Week Endpoint in Creatinine

Description

Least Squares Mean values were controlled for investigator.

Time Frame

baseline, 12 weeks

Title

Change From Baseline to 12 Week Endpoint in Total Protein

Description

Least Squares Mean values were controlled for investigator.

Time Frame

baseline, 12 weeks

Title

Change From Baseline to 12 Weeks in Blood Pressure

Description

Least Squares Mean values were controlled for investigator.

Time Frame

baseline, 12 weeks

Title

Change From Baseline to 12 Week Endpoint in Weight

Description

Least Squares Mean values were controlled for investigator.

Time Frame

baseline, 12 weeks

Title

Change From Baseline to 12 Week Endpoint in Pulse Rate

Description

Least Squares Mean values were controlled for investigator.

Time Frame

baseline, 12 weeks

Title

Number of Participants With Suicidal Ideation or Suicidal Behaviors According to the Columbia Suicide Severity Rating Scale

Description

Time Frame

baseline through 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female outpatients with chronic low back pain Exclusion Criteria: Cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study. Acute liver injury (such as hepatitis) or severe cirrhosis. Previous exposure to duloxetine. Body Mass Index (BMI) over 40. Major depressive disorder. Daily use of narcotics.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85225

Country

United States

Facility Name

City

Cromwell

State/Province

Connecticut

ZIP/Postal Code

06416

Country

United States

Facility Name

City

Deland

State/Province

Florida

ZIP/Postal Code

32720

Country

United States

Facility Name

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

City

Brighton

State/Province

Massachusetts

ZIP/Postal Code

02135

Country

United States

Facility Name

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73109

Country

United States

Facility Name

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

Facility Name

City

Sa Coma

ZIP/Postal Code

04230000

Country

Brazil

Facility Name

City

São Paulo

ZIP/Postal Code

04026-000

Country

Brazil

Facility Name

City

Aalen

ZIP/Postal Code

73430

Country

Germany

Facility Name

City

Alzenau

ZIP/Postal Code

63755

Country

Germany

Facility Name

City

Berlin

ZIP/Postal Code

10629

Country

Germany

Facility Name

City

Ellwangen

ZIP/Postal Code

73479

Country

Germany

Facility Name

City

Hamburg

ZIP/Postal Code

20255

Country

Germany

Facility Name

City

Wiesbaden

ZIP/Postal Code

65189

Country

Germany

Facility Name

City

Rotterdam

ZIP/Postal Code

3039 BD

Country

Netherlands

Facility Name

City

Krakow

ZIP/Postal Code

30-349

Country

Poland

Facility Name

City

Lublin

ZIP/Postal Code

20-093

Country

Poland

Facility Name

City

Poznan

ZIP/Postal Code

61-289

Country

Poland

Facility Name

City

Szczecin

ZIP/Postal Code

70-376

Country

Poland

Facility Name

City

Moscow

ZIP/Postal Code

119992

Country

Russian Federation

Facility Name

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

City

Bilboa

ZIP/Postal Code

48013

Country

Spain

Facility Name

City

Getafe

ZIP/Postal Code

28905

Country

Spain

Facility Name

City

La Coruña

ZIP/Postal Code

15006

Country

Spain

Facility Name

City

Madrid

ZIP/Postal Code

28009

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

20472510

Citation

Skljarevski V, Zhang S, Desaiah D, Alaka KJ, Palacios S, Miazgowski T, Patrick K. Duloxetine versus placebo in patients with chronic low back pain: a 12-week, fixed-dose, randomized, double-blind trial. J Pain. 2010 Dec;11(12):1282-90. doi: 10.1016/j.jpain.2010.03.002. Epub 2010 May 15.

Results Reference

background

PubMed Identifier

24650448

Citation

Williamson OD, Schroer M, Ruff DD, Ahl J, Margherita A, Sagman D, Wohlreich MM. Onset of response with duloxetine treatment in patients with osteoarthritis knee pain and chronic low back pain: a post hoc analysis of placebo-controlled trials. Clin Ther. 2014 Apr 1;36(4):544-51. doi: 10.1016/j.clinthera.2014.02.009. Epub 2014 Mar 17.

Results Reference

derived

Learn more about this trial

A Study for Patient With Chronic Low Back Pain

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