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Duloxetine Versus Placebo in Chronic Low Back Pain

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Back Pain Without Radiation

Intervention: Duloxetine (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company

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.

Clinical Details

Official title: Protocol F1J-MC-HMEO Duloxetine Versus Placebo in the Treatment of Chronic Low Back Pain

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

Primary outcome:

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

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

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

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

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

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

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

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

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

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

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

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

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

Secondary outcome:

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

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

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

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

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

Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Worst Pain Score

Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Least Pain Score

Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Average Pain Score

Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Pain Right Now Score

Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - General Activity

Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Mood

Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Walking Ability

Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Normal Work

Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Relations With Other People

Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Sleep

Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Enjoyment of Life

Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Average Interference

Response to Treatment, as Defined by a 30% Reduction of Weekly Mean Score in 24-hour Average Pain Severity Ratings, Last Observation Carried Forward

Response to Treatment, as Defined by a 50% Reduction of Weekly Mean Score in 24-hour Average Pain Severity Ratings, Last Observation Carried Forward

Change From Baseline to Week 13 Endpoint in Athens Insomnia Scale

Change From Baseline to Week 13 Endpoint in the 36-item Short-Form Health Survey (SF36)- Mental Component Summary (MCS)

Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Component Summary (PCS)

Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Bodily Pain

Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - General Health

Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Mental Health

Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Functioning

Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Emotional

Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Physical

Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Social Functioning

Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Vitality

Change From Baseline to Week 13 Endpoint in the Euro-Quality of Life Questionnaire - 5 Dimension - US Based Index Score

Change From Baseline to Week 13 Endpoint in Beck Depression Inventory-II Total Score

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

Adverse Events Reported as Reason for Discontinuation

Change From Baseline to Week 13 Endpoint in Laboratory Assessments - Alkaline Phosphatase

Change From Baseline to 13 Week Endpoint in Laboratory Assessments - Alanine Transaminase

Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bicarbonate, HCO3

Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Direct

Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Total

Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Chloride

Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Cholesterol

Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Creatinine

Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Potassium

Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Uric Acid

Change From Baseline to Week 13 Endpoint in Vital Signs - Pulse Rate

Change From Baseline to Week 13 Endpoint in Vital Signs - Systolic Blood Pressure

Change From Baseline to Week 13 Endpoint in Vital Signs - Diastolic Blood Pressure

Change From Baseline to Week 13 Endpoint in Vital Signs - Weight

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: - Male/Female outpatients 18 years of age with chronic low back pain.

Exclusion Criteria: - You have a serious or unstable disease 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, or 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 major depressive

disorder. - Require daily narcotics.

Locations and Contacts

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

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

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

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

Additional Information

Starting date: December 2006
Last updated: November 19, 2009

Page last updated: August 20, 2015

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