Phase 4
N=216
Maintenance of Effect of Duloxetine in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)
Diabetic Neuropathies
Bottom Line
View on ClinicalTrials.gov: NCT00322621 ↗Enrolled (actual)
216
Serious AEs
6.7%
Results posted
Dec 2009
Primary outcome: Primary: Change From Baseline (Week 8) in Brief Pain Inventory (BPI) 24-hour Average Pain Item Score at Week 34 Endpoint — 0.35 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Duloxetine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Oct 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline (Week 8) in Brief Pain Inventory (BPI) 24-hour Average Pain Item Score at Week 34 Endpoint |
0.35 | <0.001 sig |
| SECONDARY Maintenance Arm: Number of Patients With a ≥50% Reduction From Baseline (Week 0) in Brief Pain Inventory 24-hour Average Pain Item |
76 | — |
| SECONDARY Rescue Arm: Number of Patients With a ≥50% Reduction From Baseline (Week 0) in Brief Pain Inventory 24-hour Average Pain Item |
21 | — |
| SECONDARY Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Worst Pain Score at Week 34 Endpoint |
0.29 | 0.269 |
| SECONDARY Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Worst Pain Score at Week 34 Endpoint |
-1.33 | <0.001 sig |
| SECONDARY Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Least Pain Score at Week 34 Endpoint |
0.24 | 0.160 |
| SECONDARY Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Least Pain Score at Week 34 Endpoint |
-0.93 | 0.016 sig |
| SECONDARY Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Pain Score at Week 34 Endpoint |
0.35 | 0.075 |
| SECONDARY Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Pain Score at 34 Week Endpoint |
-1.39 | <0.001 sig |
| SECONDARY Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Pain Right Now Score at Week 34 Endpoint |
0.48 | 0.026 sig |
| SECONDARY Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Pain Right Now Score at Week 34 Endpoint |
-1.12 | 0.011 sig |
| SECONDARY Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: General Activity at Week 34 Endpoint |
0.22 | 0.406 |
| SECONDARY Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: General Activity at Week 34 Endpoint |
-1.01 | 0.021 sig |
| SECONDARY Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Mood at Week 34 Endpoint |
0.39 | 0.124 |
| SECONDARY Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Mood at Week 34 Endpoint |
-0.29 | 0.505 |
| SECONDARY Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Walking Ability at Week 34 Endpoint |
0.59 | 0.058 |
| SECONDARY Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Walking Ability at 34 Week Endpoint |
-1.15 | 0.009 sig |
| SECONDARY Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Normal Work at Week 34 Endpoint |
0.63 | 0.016 sig |
| SECONDARY Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Normal Work at Week 34 Endpoint |
-0.97 | 0.022 sig |
| SECONDARY Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Relations With Other People at Week 34 Endpoint |
0.13 | 0.550 |
| SECONDARY Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Relations With Other People at Week 34 Endpoint |
-0.12 | 0.752 |
| SECONDARY Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Sleep at Week 34 Endpoint |
-0.10 | 0.713 |
| SECONDARY Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Sleep at Week 34 Endpoint |
-0.84 | 0.066 |
| SECONDARY Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Enjoyment of Life at Week 34 Endpoint |
0.11 | 0.711 |
| SECONDARY Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Enjoyment of Life at Week 34 Endpoint |
0.19 | 0.678 |
| SECONDARY Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Interference at Week 34 Endpoint |
0.28 | 0.216 |
| SECONDARY Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Interference at Week 34 Endpoint |
-0.59 | 0.113 |
| SECONDARY Maintenance Arm: Patient's Global Impressions of Improvement (PGI-I) at Week 34 Endpoint |
2.32 | — |
| SECONDARY Rescue Arm: Patient's Global Impressions of Improvement (PGI-I) at Week 34 Endpoint |
3.04 | — |
| SECONDARY Maintenance Arm: Change From Baseline (Week 8) in Clinical Global Impressions of Severity (CGI-S) at Week 34 Endpoint |
-0.11 | 0.368 |
| SECONDARY Rescue Arm: Change From Baseline (Week 8) in Clinical Global Impressions of Severity (CGI-S) at Week 34 Endpoint |
-0.46 | 0.003 sig |
| SECONDARY Maintenance Arm: Change From Baseline (Week 8) in Sensory Portion of the Short-Form McGill Pain Questionnaire at Week 34 Endpoint |
0.31 | 0.666 |
| SECONDARY Rescue Arm: Change From Baseline (Week 8) in Sensory Portion of the Short-Form McGill Pain Questionnaire at Week 34 Endpoint |
-1.38 | 0.138 |
| SECONDARY Maintenance Arm: Change From Baseline (Week 8) in Beck Depression Inventory-II (BDI-II) Total Score at Week 34 Endpoint |
-0.82 | 0.145 |
| SECONDARY Rescue Arm: Change From Baseline (Week 8) in Beck Depression Inventory-II (BDI-II) Total Score at Week 34 Endpoint |
-0.53 | 0.512 |
| SECONDARY Number of Participants Discontinuing in the Acute Phase |
216; 201; 184 | — |
| SECONDARY Number of Participants Discontinuing in Maintenance / Rescue Phase |
184; 103; 12; 69; 171; 96 | — |
| SECONDARY Change From Baseline in Vital Signs: Heart Rate at Week 34 Endpoint |
2.4; 0.4 | — |
| SECONDARY Change From Baseline (Week 0) in Vital Signs: Diastolic Blood Pressure at Week 34 Endpoint |
-0.1; -1.0 | — |
| SECONDARY Change From Baseline (Week 0) in Vital Signs: Systolic Blood Pressure at Week 34 Endpoint |
-4.2; 0.7 | — |
| SECONDARY Change From Baseline (Week 0) in Vital Signs: Weight at Week 34 Endpoint |
-1.3; 0.2 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00322621). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.