Phase 3
Completed N=405
A Study in Participants With Diabetic Peripheral Neuropathic Pain in China
Diabetic Neuropathy, Painful
Source: ClinicalTrials.gov NCT01179672 ↗
Enrolled (actual)
405
Serious AEs
1.4%
Results posted
Jul 2014
Primary outcomePrimary: Mean Change From Baseline at 12-Week Endpoint in the Weekly Mean of Pain Severity Score — -2.40; -1.97 units on a scale — p=0.030
Summary
The purpose of this trial is to assess the efficacy of duloxetine 60 milligrams (mg) once daily (QD) compared with placebo, on the change in pain severity from baseline to 12 weeks as measured by the weekly mean of the daily pain scores recorded in the participant's diary in participants with diabetic peripheral neuropathic pain.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline at 12-Week Endpoint in the Weekly Mean of Pain Severity Score |
-2.40; -1.97 | 0.030 sig |
| SECONDARY Mean Change From Baseline at 12-Week Endpoint in Weekly Mean of Night Pain and Worst Pain |
-2.65; -2.11; -2.80; -2.25 | 0.008 sig |
| SECONDARY Mean Change From Baseline at 12-Week Endpoint in the BPI-Severity Scale |
-2.50; -2.00 | 0.016 sig |
| SECONDARY Mean Change From Baseline at 12-Week Endpoint in the CGI-S Scale |
-1.40; -1.17 | 0.081 |
| SECONDARY Patient Global Impression of Improvement (PGI-I) Scale at 12-Week Endpoint |
2.44; 2.65 | 0.034 sig |
| SECONDARY Mean Change From Baseline at 12-Week Endpoint in the Sensory Subscale of the SF-MPQ |
-6.45; -5.33 | 0.022 sig |
| SECONDARY Percentage of Participants Who Experience Equal to or Greater Than 30%, 50% or 75% Reduction From Baseline at 12-Week Endpoint in Weekly Mean of Average Daily Pain |
61.5; 49.0; 42.0; 28.8; 14.5; 9.6 | 0.014 sig |
| SECONDARY Percentage of Participants Who Experienced Equal to or Greater Than 30%, 50% or 75% Reduction From Baseline at 12-week Endpoint in BPI-Severity Average Pain Score |
63.0; 46.7; 46.0; 29.4; 15.0; 9.6 | 0.003 sig |
| SECONDARY Mean Change From Baseline at 12-week Endpoint in the BPI Interference Score |
-2.42; -1.82 | 0.001 sig |
| SECONDARY Mean Change From Baseline at 12 Week Endpoint in the SDS Total Score |
-6.36; -5.09 | 0.020 sig |
Eligibility Criteria
Inclusion Criteria
- Present with pain due to bilateral peripheral neuropathy
- Participants must have pain caused by Type 1 or Type 2 diabetes mellitus
- Pain must begin in the feet with relatively symmetrical onset
- Daily pain should be present for at least 6 months
- Diagnosis must be confirmed by a score of at least 3 on the Michigan Neuropathy Screening Inventory (MNSI)
- Females must test negative for a serum pregnancy test at Screening. Females of child-bearing potential (who are not surgically sterilized and between menarche and 1 year postmenopause) must agree to use a medically acceptable and reliable means of birth control, during the study and for 1 month following the last study dose.
- Stable glycemic control as assessed by a physician investigator and a glycosylated hemoglobin (HbA1c) 1.5 times ULN, based on central laboratory reference ranges at Screening.
- Historical exposure to drugs known to cause neuropathy, or a history of a medical condition, including pernicious anemia and hypothyroidism, that could have been responsible for neuropathy
- Pain that cannot be clearly differentiated from or conditions that interfere with the assessment of the diabetic neuropathy pain. Examples of painful conditions that could be confused with diabetic neuropathy pain include peripheral vascular disease, neurological disorders unrelated to diabetic neuropathy, skin condition in the area of the neuropathy that could alter sensation, other painful conditions
- Participants who have previously completed or withdrawn from this study or have been previously treated with duloxetine, including participants who participated in study F1J-MC-HMEQ (NCT00408993), even those in the placebo arm
- Participants taking excluded medications that cannot be stopped at Screening
- Treatment with a monoamine oxidase inhibitor (MAOI) or fluoxetine within 30 days of the third Screening
- Participants with a positive Hepatitis B surface antigen and/or Hepatitis C antibody are to be excluded if they have any of the following:
- Hepatic dysfunction as determined by the investigator or
- Clinical manifestations of liver disease within the previous year such as unexplained pruritus, unexplained dark urine, jaundice, unexplained right upper quadrant tenderness, unexplained "flu-like" symptoms or
- Aspartate transaminase (AST), ALT, or bilirubin above the normal reference range.
Data sourced from ClinicalTrials.gov (NCT01179672). 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. Informational only — not medical advice.