Clinical trial NCT00322621: Maintenance of Effect of Duloxetine in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)
Official title: Maintenance of Effect of Duloxetine 60 mg Once Daily in Patients With Diabetic Peripheral Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Neuropathies
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Boehringer Ingelheim
First posted: 2006-05-08
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline (Week 8) in Brief Pain Inventory (BPI) 24-hour Average Pain Item Score at Week 34 Endpoint
timeFrame: Baseline (Week 8), Week 34
Secondary outcomes:
measure: Maintenance Arm: Number of Patients With a ≥50% Reduction From Baseline (Week 0) in Brief Pain Inventory 24-hour Average Pain Item
timeFrame: Baseline (Week 0), Week 34
measure: Rescue Arm: Number of Patients With a ≥50% Reduction From Baseline (Week 0) in Brief Pain Inventory 24-hour Average Pain Item
timeFrame: Baseline (Week 0), Week 34
measure: Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Worst Pain Score at Week 34 Endpoint
timeFrame: Baseline (Week 8), Week 34
measure: Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Worst Pain Score at Week 34 Endpoint
timeFrame: Baseline (Week 8), Week 34
measure: Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Least Pain Score at Week 34 Endpoint
timeFrame: Baseline (Week 8), Week 34
measure: Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Least Pain Score at Week 34 Endpoint
timeFrame: Baseline (Week 8), Week 34
measure: Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Pain Score at Week 34 Endpoint
timeFrame: Baseline (Week 8), Week 34
measure: Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Pain Score at 34 Week Endpoint
timeFrame: Baseline (Week 8), Week 34
measure: Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Pain Right Now Score at Week 34 Endpoint
timeFrame: Baseline (Week 8), Week 34
measure: Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Pain Right Now Score at Week 34 Endpoint
timeFrame: Baseline (Week 8), Week 34
measure: Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: General Activity at Week 34 Endpoint
timeFrame: Baseline (Week 8), Week 34
measure: Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: General Activity at Week 34 Endpoint
timeFrame: Baseline (Week 8), Week 34
measure: Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Mood at Week 34 Endpoint
timeFrame: Baseline (Week 8), Week 34
measure: Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Mood at Week 34 Endpoint
timeFrame: Baseline (Week 8), Week 34
measure: Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Walking Ability at Week 34 Endpoint
timeFrame: Baseline (Week 8), Week 34
measure: Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Walking Ability at 34 Week Endpoint
timeFrame: Baseline (Week 8), Week 34
measure: Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Normal Work at Week 34 Endpoint
timeFrame: Baseline (Week 8), Week 34
measure: Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Normal Work at Week 34 Endpoint
timeFrame: Baseline (Week 8), Week 34
measure: Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Relations With Other People at Week 34 Endpoint
timeFrame: Baseline (Week 8), Week 34
measure: Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Relations With Other People at Week 34 Endpoint
timeFrame: Baseline (Week 8), Week 34
measure: Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Sleep at Week 34 Endpoint
timeFrame: Baseline (Week 8), Week 34
measure: Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Sleep at Week 34 Endpoint
timeFrame: Baseline (Week 8), Week 34
measure: Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Enjoyment of Life at Week 34 Endpoint
timeFrame: Baseline (Week 8), Week 34
measure: Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Enjoyment of Life at Week 34 Endpoint
timeFrame: Baseline (Week 8), Week 34
measure: Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Interference at Week 34 Endpoint
timeFrame: Baseline (Week 8), Week 34
measure: Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Interference at Week 34 Endpoint
timeFrame: Baseline (Week 8), Week 34
measure: Maintenance Arm: Patient's Global Impressions of Improvement (PGI-I) at Week 34 Endpoint
timeFrame: Week 34
measure: Rescue Arm: Patient's Global Impressions of Improvement (PGI-I) at Week 34 Endpoint
timeFrame: Week 34
measure: Maintenance Arm: Change From Baseline (Week 8) in Clinical Global Impressions of Severity (CGI-S) at Week 34 Endpoint
timeFrame: Baseline (Week 8), Week 34
measure: Rescue Arm: Change From Baseline (Week 8) in Clinical Global Impressions of Severity (CGI-S) at Week 34 Endpoint
timeFrame: Baseline (Week 8), Week 34
measure: Maintenance Arm: Change From Baseline (Week 8) in Sensory Portion of the Short-Form McGill Pain Questionnaire at Week 34 Endpoint
timeFrame: Baseline (Week 8), Week 34
measure: Rescue Arm: Change From Baseline (Week 8) in Sensory Portion of the Short-Form McGill Pain Questionnaire at Week 34 Endpoint
timeFrame: Baseline (Week 8), Week 34
measure: Maintenance Arm: Change From Baseline (Week 8) in Beck Depression Inventory-II (BDI-II) Total Score at Week 34 Endpoint
timeFrame: Baseline (Week 8), Week 34
measure: Rescue Arm: Change From Baseline (Week 8) in Beck Depression Inventory-II (BDI-II) Total Score at Week 34 Endpoint
timeFrame: Baseline (Week 8), Week 34
measure: Number of Participants Discontinuing in the Acute Phase
timeFrame: Baseline (Week 0) to Week 8
measure: Number of Participants Discontinuing in Maintenance / Rescue Phase
timeFrame: Baseline (Week 8) to Week 34
measure: Change From Baseline in Vital Signs: Heart Rate at Week 34 Endpoint
timeFrame: Baseline (Week 0), Week 34
measure: Change From Baseline (Week 0) in Vital Signs: Diastolic Blood Pressure at Week 34 Endpoint
timeFrame: Baseline (Week 0), Week 34
measure: Change From Baseline (Week 0) in Vital Signs: Systolic Blood Pressure at Week 34 Endpoint
timeFrame: Baseline (Week 0), Week 34
measure: Change From Baseline (Week 0) in Vital Signs: Weight at Week 34 Endpoint
timeFrame: Baseline (Week 0), Week 34
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: 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.
city: Porto Alegre
country: Brazil
facility: 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.
city: Angers
country: France
facility: 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.
city: Annecy
country: France
facility: 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.
city: Bron
country: France
facility: 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.
city: Dijon
country: France
facility: 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.
city: Narbonne
country: France
facility: 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.
city: Nevers
country: France
facility: 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.
city: Nice
country: France
facility: 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.
city: Chemitz
country: Germany
facility: 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.
city: Dresden
country: Germany
facility: 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.
city: Mainz
country: Germany
facility: 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.
city: Münster
country: Germany
facility: 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.
city: Schkeuditz
country: Germany
facility: 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.
city: Siegen
country: Germany
facility: 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.
city: Wurzburg
country: Germany
facility: 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.
city: Genova
country: Italy
facility: 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.
city: Perugia
country: Italy
facility: 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.
city: Rome
country: Italy
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: Skljarevski V, Desaiah D, Zhang Q, Chappell AS, Detke MJ, Gross JL, Ziegler D. Evaluating the maintenance of effect of duloxetine in patients with diabetic peripheral neuropathic pain. Diabetes Metab Res Rev. 2009 Oct;25(7):623-31. doi: 10.1002/dmrr.1000.
citation: Hall JA, Wang F, Oakes TM, Utterback BG, Crucitti A, Acharya N. Safety and tolerability of duloxetine in the acute management of diabetic peripheral neuropathic pain: analysis of pooled data from three placebo-controlled clinical trials. Expert Opin Drug Saf. 2010 Jul;9(4):525-37. doi: 10.1517/14740338.2010.484418.