Maintenance of Effect of Duloxetine in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)

February 3, 2011 updated by: Eli Lilly and Company

Maintenance of Effect of Duloxetine 60 mg Once Daily in Patients With Diabetic Peripheral Neuropathic Pain

To determine if duloxetine 60 mg once daily can work up to 6 months in treating pain from Diabetic Neuropathy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

216

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Fortaleza, Brazil, 60120-020
        • 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.
      • Porto Alegre, Brazil, 90035170
        • 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.
  • France
      • Angers, France, 49033
        • 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.
      • Annecy, France, 74011
        • 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.
      • Bron, France, 69500
        • 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.
      • Dijon, France, 21079
        • 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.
      • Narbonne, France, 11108
        • 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.
      • Nevers, France, 58000
        • 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.
      • Nice, France, 06002
        • 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.
  • Germany
      • Chemitz, Germany, 09111
        • 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, Germany, 01307
        • 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.
      • Mainz, Germany, D-55116
        • 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.
      • Münster, Germany, 48145
        • 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.
      • Schkeuditz, Germany, 04435
        • 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, Germany, 57072
        • 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.
      • Wurzburg, Germany, 97070
        • 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.
  • Italy
      • Genova, Italy, 16132
        • 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.
      • Perugia, Italy, 06100
        • 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.
      • Rome, Italy, 00161
        • 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have pain due to bilateral peripheral neuropathy caused by Type I or Type II diabetes with the pain beginning in the feet and present for at least 6 months.
  • May not be pregnant and agree to utilize medically acceptable and reliable means of birth control during participation in the study.
  • Score of 4 or greater on the Brief Pain Inventory on the 24-hour average pain item.

Exclusion Criteria:

  • History of substance abuse or dependence within the past year, excluding nicotine and caffeine.
  • Serious or unstable cardiovascular, hepatic (acute liver injury such as hepatitis or severe cirrhosis),kidney, respiratory, or blood disorder, seizure disorder, problems with peripheral vascular disease, or other medical conditions or psychiatric conditions that would hinder your participation or be likely to lead to hospitalization during the course of the study.
  • Taking monoamine oxidase inhibitor (MAOI) within 14 days of starting the study or the potential need to take during or within 5 days after discontinuation from the study.
  • Treatment with fluoxetine within 30 days of starting the study.
  • Unstable blood sugar control and uncontrolled or poorly controlled hypertension.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Duloxetine
All subjects receive 30 mg once daily (QD), by mouth (per os - PO) for 1 week followed by duloxetine 60 mg QD, PO for 7 weeks, then maintenance at 60 mg QD, PO for responders to 6 months and rescue at 120 mg QD, PO for non-responders to 6 months. Patients beginning maintenance at the 60 mg QD dose could be increased to the 120 mg QD level if they did not maintain appropriate level of response throughout the maintenance period.
Drug: Duloxetine
Other Names:
  • Cymbalta
  • LY248686

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline (Week 8) in Brief Pain Inventory (BPI) 24-hour Average Pain Item Score at Week 34 Endpoint
Time Frame: Baseline (Week 8), Week 34
Maintenance effect of duloxetine 60 mg in patients with diabetic peripheral neuropathic pain (DPNP) was assessed by the change in BPI 24-hour average pain item score from baseline of the maintenance therapy arm (week 8) to 34 week endpoint in patients who achieved at least a 30 percent reduction on the BPI 24-hour average pain item after 8 weeks of acute therapy (Acute Therapy Phase). BPI is 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).
Baseline (Week 8), Week 34

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maintenance Arm: Number of Patients With a ≥50% Reduction From Baseline (Week 0) in Brief Pain Inventory 24-hour Average Pain Item
Time Frame: Baseline (Week 0), Week 34
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).
Baseline (Week 0), Week 34
Rescue Arm: Number of Patients With a ≥50% Reduction From Baseline (Week 0) in Brief Pain Inventory 24-hour Average Pain Item
Time Frame: Baseline (Week 0), Week 34
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).
Baseline (Week 0), Week 34
Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Worst Pain Score at Week 34 Endpoint
Time Frame: Baseline (Week 8), Week 34
A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Baseline (Week 8), Week 34
Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Worst Pain Score at Week 34 Endpoint
Time Frame: Baseline (Week 8), Week 34
A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Baseline (Week 8), Week 34
Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Least Pain Score at Week 34 Endpoint
Time Frame: Baseline (Week 8), Week 34
A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Baseline (Week 8), Week 34
Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Least Pain Score at Week 34 Endpoint
Time Frame: Baseline (Week 8), Week 34
A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Baseline (Week 8), Week 34
Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Pain Score at Week 34 Endpoint
Time Frame: Baseline (Week 8), Week 34
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).
Baseline (Week 8), Week 34
Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Pain Score at 34 Week Endpoint
Time Frame: Baseline (Week 8), Week 34
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).
Baseline (Week 8), Week 34
Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Pain Right Now Score at Week 34 Endpoint
Time Frame: Baseline (Week 8), Week 34
A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Baseline (Week 8), Week 34
Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Pain Right Now Score at Week 34 Endpoint
Time Frame: Baseline (Week 8), Week 34
A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Baseline (Week 8), Week 34
Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: General Activity at Week 34 Endpoint
Time Frame: Baseline (Week 8), Week 34
A self-reported scale that measures the interference of pain in the past 24 hours on general activity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Baseline (Week 8), Week 34
Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: General Activity at Week 34 Endpoint
Time Frame: Baseline (Week 8), Week 34
A self-reported scale that measures the interference of pain in the past 24 hours on general activity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Baseline (Week 8), Week 34
Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Mood at Week 34 Endpoint
Time Frame: Baseline (Week 8), Week 34
A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Baseline (Week 8), Week 34
Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Mood at Week 34 Endpoint
Time Frame: Baseline (Week 8), Week 34
A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Baseline (Week 8), Week 34
Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Walking Ability at Week 34 Endpoint
Time Frame: Baseline (Week 8), Week 34
A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Baseline (Week 8), Week 34
Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Walking Ability at 34 Week Endpoint
Time Frame: Baseline (Week 8), Week 34
A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Baseline (Week 8), Week 34
Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Normal Work at Week 34 Endpoint
Time Frame: Baseline (Week 8), Week 34
A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Baseline (Week 8), Week 34
Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Normal Work at Week 34 Endpoint
Time Frame: Baseline (Week 8), Week 34
A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Baseline (Week 8), Week 34
Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Relations With Other People at Week 34 Endpoint
Time Frame: Baseline (Week 8), Week 34
A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Baseline (Week 8), Week 34
Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Relations With Other People at Week 34 Endpoint
Time Frame: Baseline (Week 8), Week 34
A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Baseline (Week 8), Week 34
Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Sleep at Week 34 Endpoint
Time Frame: Baseline (Week 8), Week 34
A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Baseline (Week 8), Week 34
Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Sleep at Week 34 Endpoint
Time Frame: Baseline (Week 8), Week 34
A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Baseline (Week 8), Week 34
Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Enjoyment of Life at Week 34 Endpoint
Time Frame: Baseline (Week 8), Week 34
A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Baseline (Week 8), Week 34
Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Enjoyment of Life at Week 34 Endpoint
Time Frame: Baseline (Week 8), Week 34
A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Baseline (Week 8), Week 34
Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Interference at Week 34 Endpoint
Time Frame: Baseline (Week 8), Week 34
A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Baseline (Week 8), Week 34
Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Interference at Week 34 Endpoint
Time Frame: Baseline (Week 8), Week 34
A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Baseline (Week 8), Week 34
Maintenance Arm: Patient's Global Impressions of Improvement (PGI-I) at Week 34 Endpoint
Time Frame: Week 34
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).
Week 34
Rescue Arm: Patient's Global Impressions of Improvement (PGI-I) at Week 34 Endpoint
Time Frame: Week 34
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).
Week 34
Maintenance Arm: Change From Baseline (Week 8) in Clinical Global Impressions of Severity (CGI-S) at Week 34 Endpoint
Time Frame: Baseline (Week 8), Week 34
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).
Baseline (Week 8), Week 34
Rescue Arm: Change From Baseline (Week 8) in Clinical Global Impressions of Severity (CGI-S) at Week 34 Endpoint
Time Frame: Baseline (Week 8), Week 34
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).
Baseline (Week 8), Week 34
Maintenance Arm: Change From Baseline (Week 8) in Sensory Portion of the Short-Form McGill Pain Questionnaire at Week 34 Endpoint
Time Frame: Baseline (Week 8), Week 34
This instrument consists of 11 pain descriptors. The sensory pain portion scores range from 0 (none) to 3 (severe).
Baseline (Week 8), Week 34
Rescue Arm: Change From Baseline (Week 8) in Sensory Portion of the Short-Form McGill Pain Questionnaire at Week 34 Endpoint
Time Frame: Baseline (Week 8), Week 34
This instrument consists of 11 pain descriptors. The sensory pain portion scores range from 0 (none) to 3 (severe).
Baseline (Week 8), Week 34
Maintenance Arm: Change From Baseline (Week 8) in Beck Depression Inventory-II (BDI-II) Total Score at Week 34 Endpoint
Time Frame: Baseline (Week 8), Week 34
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.
Baseline (Week 8), Week 34
Rescue Arm: Change From Baseline (Week 8) in Beck Depression Inventory-II (BDI-II) Total Score at Week 34 Endpoint
Time Frame: Baseline (Week 8), Week 34
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.
Baseline (Week 8), Week 34
Number of Participants Discontinuing in the Acute Phase
Time Frame: Baseline (Week 0) to Week 8
Baseline (Week 0) to Week 8
Number of Participants Discontinuing in Maintenance / Rescue Phase
Time Frame: Baseline (Week 8) to Week 34
Baseline (Week 8) to Week 34
Change From Baseline in Vital Signs: Heart Rate at Week 34 Endpoint
Time Frame: Baseline (Week 0), Week 34
Baseline (Week 0), Week 34
Change From Baseline (Week 0) in Vital Signs: Diastolic Blood Pressure at Week 34 Endpoint
Time Frame: Baseline (Week 0), Week 34
Baseline (Week 0), Week 34
Change From Baseline (Week 0) in Vital Signs: Systolic Blood Pressure at Week 34 Endpoint
Time Frame: Baseline (Week 0), Week 34
Baseline (Week 0), Week 34
Change From Baseline (Week 0) in Vital Signs: Weight at Week 34 Endpoint
Time Frame: Baseline (Week 0), Week 34
Baseline (Week 0), Week 34

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Collaborators

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

May 5, 2006

First Submitted That Met QC Criteria

May 5, 2006

First Posted (Estimate)

May 8, 2006

Study Record Updates

Last Update Posted (Estimate)

February 7, 2011

Last Update Submitted That Met QC Criteria

February 3, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10258
  • F1J-MC-HMEM (Other Identifier: Eli Lilly and Company)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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