NCT00408876

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
404

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

December 29, 2009

Completed
Last Updated

December 29, 2009

Status Verified

November 1, 2009

Enrollment Period

11 months

First QC Date

December 6, 2006

Results QC Date

November 7, 2008

Last Update Submit

November 19, 2009

Conditions

Back Pain Without Radiation

Outcome Measures

Primary Outcomes (13)

  • Change From Baseline to Week 1 in Weekly Mean of the 24-hour Average Pain Scores

    24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 1), with scores ranging from 0 (no pain) to 10 (worst possible pain).

    Baseline, Week 1

  • Change From Baseline to Week 2 in Weekly Mean of the 24-Hour Average Pain Scores

    24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 2), with scores ranging from 0 (no pain) to 10 (worst possible pain).

    Baseline, Week 2

  • Change From Baseline to Week 3 in Weekly Mean of the 24-Hour Average Pain Scores

    24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 3), with scores ranging from 0 (no pain) to 10 (worst possible pain).

    Baseline, Week 3

  • Change From Baseline to Week 4 in Weekly Mean of the 24-Hour Average Pain Scores

    24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 4), with scores ranging from 0 (no pain) to 10 (worst possible pain).

    Baseline, Week 4

  • Change From Baseline to Week 5 in Weekly Mean of the 24-Hour Average Pain Scores

    24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 5), with scores ranging from 0 (no pain) to 10 (worst possible pain).

    Baseline, Week 5

  • Change From Baseline to Week 6 in Weekly Mean of the 24-Hour Average Pain Scores

    24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 6), with scores ranging from 0 (no pain) to 10 (worst possible pain).

    Baseline, Week 6

  • Change From Baseline to Week 7 in Weekly Mean of the 24-Hour Average Pain Scores

    24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 7), with scores ranging from 0 (no pain) to 10 (worst possible pain).

    Baseline, Week 7

  • Change From Baseline to Week 8 in Weekly Mean of the 24-Hour Average Pain Scores

    24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 8), with scores ranging from 0 (no pain) to 10 (worst possible pain).

    Baseline, Week 8

  • Change From Baseline to Week 9 in Weekly Mean of the 24-Hour Average Pain Scores

    24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 1), with scores ranging from 0 (no pain) to 10 (worst possible pain).

    Baseline, Week 9

  • Change From Baseline to Week 10 in Weekly Mean of the 24-Hour Average Pain Scores

    24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 10), with scores ranging from 0 (no pain) to 10 (worst possible pain).

    Baseline, Week 10

  • Change From Baseline to Week 11 in Weekly Mean of the 24-Hour Average Pain Scores

    24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 11), with scores ranging from 0 (no pain) to 10 (worst possible pain).

    Baseline, Week 11

  • Change From Baseline to Week 12 in Weekly Mean of the 24-Hour Average Pain Scores

    24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 12), with scores ranging from 0 (no pain) to 10 (worst possible pain).

    Baseline, Week 12

  • Change From Baseline to Week 13 Endpoint in Weekly Mean of the 24-Hour Average Pain Scores

    24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 13), with scores ranging from 0 (no pain) to 10 (worst possible pain).

    Baseline, Week 13

Secondary Outcomes (48)

  • Patient's Global Impression - Improvement (PGI-I) at Week 13 Endpoint

    Week 13

  • Change From Baseline to Week 13 Endpoint in Roland-Morris Disability Questionnaire (RMDQ) Total Score

    Baseline, Week 13

  • Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean 24-Hour Night Pain Score

    Baseline, Week 13

  • Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean of Worst Pain Score

    Baseline, Week 13

  • Change From Baseline to Week 13 Endpoint in Clinical Global Impression of Severity

    Baseline, Week 13

  • +43 more secondary outcomes

Study Arms (4)

Duloxetine 20 mg

EXPERIMENTAL

duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks

Drug: Duloxetine

Duloxetine 60 mg

EXPERIMENTAL

duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks

Drug: Duloxetine

Duloxetine 120 mg

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

placebo once a day (QD), by mouth (PO) for 13 weeks

Drug: Placebo

Interventions

DuloxetineDRUG
Also known as: LY248686, Cymbalta
Duloxetine 120 mgDuloxetine 20 mgDuloxetine 60 mg
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

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, 33912, United States

Location

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, 32806, United States

Location

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, 33143, United States

Location

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, 33606, United States

Location

Related Publications (1)

  • 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.

    PMID: 24650448DERIVED

MeSH Terms

Conditions

Back Pain

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
1-800-545-5979

Study Officials

  • 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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 6, 2006

First Posted

December 7, 2006

Study Start

December 1, 2006

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

December 29, 2009

Results First Posted

December 29, 2009

Record last verified: 2009-11

Locations

US(4)