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An Open-Label Comparison of Duloxetine to Other Alternatives for the Management of Diabetic Peripheral Neuropathic 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: Diabetic Neuropathy, Painful

Intervention: duloxetine hydrochloride (Drug); pregabalin (Drug); gabapentin (Drug)

Phase: Phase 4

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

To test the non-inferiority of duloxetine monotherapy as a treatment for the management of diabetic peripheral neuropathic pain as compared to pregabalin treatment among patients who have not had an adequate response to gabapentin.

Clinical Details

Official title: An Open-Label, Randomized Comparison of Duloxetine, Pregabalin, and the Combination of Duloxetine and Gabapentin Among Patients With Inadequate Response to Gabapentin for the Management of Diabetic Peripheral Neuropathic Pain

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Pregabalin Compared With Duloxetine

Secondary outcome:

Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Duloxetine Compared With Duloxetine+Gabapentin

Mean Change From Baseline to 12 Weeks in Weekly Mean of Nighttime Pain Severity

Mean Change From Baseline to 12 Weeks in Weekly Mean of the Daily Worst Pain Severity Score

Mean Change From Baseline to 12 Weeks in Clinical Global Impression of Severity Scale (CGI Severity)

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

Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: 24-hour Average Pain

Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Worst Pain

Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Least Pain

Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Pain Right Now

Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference: With General Activity

Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Mood

Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Walking Ability

Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Normal Work

Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Relations With Other People

Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Sleep

Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Enjoyment of Life

Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Mean Interference Score

Number of Participants With ≥ 30% Reduction in the Weekly Mean 24 Hour Average Pain Score at 12 Weeks

Number of Patients With a Reduction of ≥ 50% in Weekly Mean of 24 Hour Average Pain Score

Number of Participants With a ≥ 2-points Reduction on the Weekly Average of the Daily 24-hour Average Pain Scale at 12 Weeks

Mean Change From Baseline to 12 Weeks in Leeds Sleep Evaluation Questionnaire (LSEQ) Subscales of Ease of Going to Sleep (GTS), Awakening (AFS), and Behavior Following Wakefulness (BFW), Quality of Sleep (QOS)

Mean Change From Baseline to 12 Weeks in Sheehan Disability Scale (SDS) - Total Score and Scores for Items 1 to 3

Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation

Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores

Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores

Mean Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores

Categorial Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores

Path Analysis of Improvement in Pain Through Improvement in Depressive Symptoms

Mean Change From Baseline to 12 Weeks in Beck Depression Inventory II (BDI-II) Total Score

Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale

Summary of Number of Participants Who Discontinued

Time to First ≥ 30% Reduction in Weekly Mean 24 Hour Average Pain Score

Time to First ≥ 50 % Reduction in Weekly Mean 24 Hour Average Pain Score

Time to First Sustained Response in Weekly Mean 24 Hour Average Pain Score

Time to First ≥ 2 Points Reduction in Weekly Mean 24 Hour Average Pain Score

Weekly Mean Change in 24 Hour Average Pain Severity +/- Generalized Anxiety Disorder (GAD)

Weekly Mean Change From Baseline to 12 Weeks in 24 Hour Average Pain Severity - Only Participants Who Adhered to Key Protocol Requirements (Per-Protocol Population)

Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use)

Discontinuations for Abnormal Laboratory Analytes, Vital Signs, Overall and for Each Measure

Mean Change From Baseline to 12 Weeks in Blood Pressure

Mean Change From Baseline to 12 Weeks in Heart Rate

Mean Change From Baseline to 12 Weeks in Body Weight

Number of Participants With Treatment-emergent Elevated Blood Pressure

Number of Participants With Treatment-Emergent Elevated Heart Rate

Number of Participants With Treatment-Emergent Changes in Body Weight

Mean Change From Baseline to 12 Weeks in Hepatic Enzyme Serum Levels

Mean Change From Baseline to 12 Weeks in Total Bilirubin

Mean Change From Baseline to 12 Weeks in Fasting Plasma Glucose

Mean Change From Baseline to 12 Weeks in Hemoglobin A1C

Number of Patients With Treatment-Emergent Elevated Laboratory Analytes

Eligibility

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

Criteria:

Inclusion Criteria:

- You must have been diagnosed with Diabetic Neuropathic Pain

- Patient has an average daily pain score greater than or equal to 4 on an 11-point

Likert scale, and patient or provider feel that a change from the current gabapentin therapy for pain management is warranted

- Patient is currently treated with gabapentin greater than or equal to 900

milligram/day, has been prescribed the current dose for at least 4 weeks, and has been at least 80% compliant with dosing, according to patient report

- Patient must agree not to change dose of gabapentin between Visits 1 and 2

- You must have stable glycemic control

Exclusion Criteria:

- Are judged prior to randomization to be at suicidal risk as defined by a score of 2

or greater on question 9 of the Beck Depression Inventory-II (BDI-II)

- Current diagnosis or history of hemangiosarcoma

- Patients with New York Heart Association Class III or IV symptoms of congestive heart

failure

- Patients with uncontrolled narrow-angle glaucoma

- Presence of a current seizure disorder

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 physician., Bochum D-44805, 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 personal physician., Dresden 01307, 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 personal physician., Hamburg 20354, 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 personal physician., Siegen 57072, 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 personal physician., Torrance, California 90503, 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 physician., Cromwell, Connecticut 06416, 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 physician., Staten Island, New York 10312, 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 physician., Greenville, North Carolina 27834, 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 physician., Midvale, Utah 84047, United States

Additional Information

Lilly Clinical Trial Registry

Starting date: September 2006
Last updated: July 22, 2011

Page last updated: August 20, 2015

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