Back to results

Duloxetine Versus Placebo in Chronic Low Back Pain

Primary Purpose

Back Pain Without Radiation

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Duloxetine

Placebo

About this trial

This is an interventional treatment trial for Back Pain Without Radiation

Eligibility Criteria

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

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

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 p
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Duloxetine

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change From Baseline to Week 13 in Brief Pain Inventory (BPI), 24-hour Average Pain Scores

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).

Secondary Outcome Measures

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

A scale that measures the patient's perception of improvement at the time of assessment. The score ranges from 1 (very much better) to 7 (very much worse).

Change From Baseline to Week 13 and Week 54 Endpoints in Roland Morris Disability Questionnaire-24 Item (RMDQ-24) Total Score

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).

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

24-hour average pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Patients should complete the electronic diary at bedtime. The 11-point Likert scale will also be used for assessment of night pain and worst pain each day, and evaluated as weekly means. Average interference was calculated as the average of non-missing scores of individual interference items.

Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores

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, and average 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 Week 13 and Week 54 Endpoints in Clinical Global Impression of Severity (CGI-Severity)

Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).

Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 30% Score Reduction Criteria

Response to treatment was defined as at least a 30% reduction of weekly mean score in in Brief Pain Inventory (BPI) Average Pain severity ratings from baseline to endpoint. The number of participants who met this criteria are presented.

Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 50% Score Reduction Criteria

Response to treatment was defined as at least a 50% reduction of weekly mean score in in Brief Pain Inventory (BPI) Average Pain severity ratings from baseline to endpoint. The number of participants who met this criteria are presented.

Change From Baseline to Week 13 and Week 54 Endpoints in Athens Insomnia Scale

Estimates sleep difficulty. Consists of 8 items rated on a 4-point scale of 0 (no problem at all) to 3 (very serious problem). Total score of the 8-item version ranges from 0-24.

Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)

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]). MCS and PCS scores=0-100 (higher scores indicate better health status). Domain scores: general health=5-25; physical functioning=10-30; role-physical=4-8; role-emotional=3-6; social functioning=2-10; bodily pain=2-11; vitality=4-24; mental health=5-30.

Change From Baseline to Week 13 Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D)

The EuroQoL Questionnaire - 5 Dimension (EQ-5D) is a 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 the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the patient. Scores presented used the UK Based Index Score.

Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores

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. Higher scores are indicative of greater impairment. Absenteeism=(Q2/(Q2+Q4))*100 Presenteeism=(Q5/10)*100 Work productivity loss=(Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)])*100 Activity Impairment=(Q6/10)*100

Change From Baseline to Week 13 and Week 54 Endpoints in Beck Depression Inventory (BDI-II) Total Scores

A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.

Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Scores

A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'

Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Bicarbonate

Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Uric Acid

Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Pulse Rate

Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure

Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Weight

Full Information

NCT ID

NCT00424593

First Posted

January 17, 2007

Last Updated

November 18, 2009

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00424593

Brief Title

Duloxetine Versus Placebo in Chronic Low Back Pain

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

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

Back Pain Without Radiation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

236 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Duloxetine

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Duloxetine

Other Intervention Name(s)

LY248686, Cymbalta

Intervention Description

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Change From Baseline to Week 13 in Brief Pain Inventory (BPI), 24-hour Average Pain Scores

Description

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).

Time Frame

Baseline, Week 13

Secondary Outcome Measure Information:

Title

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

Description

A scale that measures the patient's perception of improvement at the time of assessment. The score ranges from 1 (very much better) to 7 (very much worse).

Time Frame

Week 13

Title

Change From Baseline to Week 13 and Week 54 Endpoints in Roland Morris Disability Questionnaire-24 Item (RMDQ-24) Total Score

Description

Time Frame

Baseline, Week 13, Week 54

Title

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

Description

Time Frame

Baseline, Week 13

Title

Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores

Description

Time Frame

Baseline, Week 13, Week 54

Title

Change From Baseline to Week 13 and Week 54 Endpoints in Clinical Global Impression of Severity (CGI-Severity)

Description

Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).

Time Frame

Baseline, Week 13, Week 54

Title

Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 30% Score Reduction Criteria

Description

Time Frame

Week 13

Title

Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 50% Score Reduction Criteria

Description

Time Frame

Week 13

Title

Change From Baseline to Week 13 and Week 54 Endpoints in Athens Insomnia Scale

Description

Estimates sleep difficulty. Consists of 8 items rated on a 4-point scale of 0 (no problem at all) to 3 (very serious problem). Total score of the 8-item version ranges from 0-24.

Time Frame

Baseline, Week 13, Week 54

Title

Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)

Description

Time Frame

Baseline, Week 13

Title

Change From Baseline to Week 13 Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D)

Description

Time Frame

Baseline, Week 13

Title

Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores

Description

Time Frame

Baseline, Week 13, Week 54

Title

Change From Baseline to Week 13 and Week 54 Endpoints in Beck Depression Inventory (BDI-II) Total Scores

Description

Time Frame

Baseline, Week 13, Week 54

Title

Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Scores

Description

Time Frame

Baseline, Week 13

Title

Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Bicarbonate

Time Frame

Baseline, Week 13

Title

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

Title

Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Pulse Rate

Time Frame

Baseline, Week 13, Week 54

Title

Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure

Time Frame

Baseline, Week 13, Week 54

Title

Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Weight

Time Frame

Baseline, Week 13, Week 54

Other Pre-specified Outcome Measures:

Title

Serious Adverse Events During the Dose-Blind Extension Phase

Description

Serious adverse events during the extension phase reported based on the original treatment group to which the patient was randomized. Dictionary used was MedDRA 11.0.

Time Frame

Week 13 though Week 54

Title

Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Patients During the Dose-Blind Extension Phase

Description

Treatment-emergent adverse events during the extension phase reported based on the original treatment group to which the patient was randomized. Dictionary used was MedDRA 11.0.

Time Frame

Week 13 through Week 54

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

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 p

City

Curitiba

ZIP/Postal Code

80060240

Country

Brazil

Facility Name

City

San Paulo

ZIP/Postal Code

04027-000

Country

Brazil

Facility Name

City

Sao Paulo

ZIP/Postal Code

04026-000

Country

Brazil

Facility Name

City

Amiens

ZIP/Postal Code

80054

Country

France

Facility Name

City

Marseille

ZIP/Postal Code

13008

Country

France

Facility Name

City

Paris

ZIP/Postal Code

75014

Country

France

Facility Name

City

Saint Affrique

ZIP/Postal Code

12400

Country

France

Facility Name

City

Saint-Etienne

ZIP/Postal Code

42055

Country

France

Facility Name

City

Ellwangen

ZIP/Postal Code

73479

Country

Germany

Facility Name

City

Graefelfing

ZIP/Postal Code

82166

Country

Germany

Facility Name

City

Hamburg

ZIP/Postal Code

22143

Country

Germany

Facility Name

City

Wiesbaden

ZIP/Postal Code

65191

Country

Germany

Facility Name

City

Mexico City

ZIP/Postal Code

06700

Country

Mexico

Facility Name

City

Monterrey

ZIP/Postal Code

64460

Country

Mexico

Facility Name

City

San Pedro Garza Garcia

ZIP/Postal Code

66260

Country

Mexico

Facility Name

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

City

Rotterdam

ZIP/Postal Code

3039 BD

Country

Netherlands

12. IPD Sharing Statement

Citations:

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

PubMed Identifier

20546509

Citation

Skljarevski V, Zhang S, Chappell AS, Walker DJ, Murray I, Backonja M. Maintenance of effect of duloxetine in patients with chronic low back pain: a 41-week uncontrolled, dose-blinded study. Pain Med. 2010 May;11(5):648-57. doi: 10.1111/j.1526-4637.2010.00836.x. Epub 2010 Apr 13.

Results Reference

derived

PubMed Identifier

20461028

Citation

Skljarevski V, Desaiah D, Liu-Seifert H, Zhang Q, Chappell AS, Detke MJ, Iyengar S, Atkinson JH, Backonja M. Efficacy and safety of duloxetine in patients with chronic low back pain. Spine (Phila Pa 1976). 2010 Jun 1;35(13):E578-85. doi: 10.1097/BRS.0b013e3181d3cef6.

Results Reference

derived

Learn more about this trial

Duloxetine Versus Placebo in Chronic Low Back Pain

We'll reach out to this number within 24 hrs