Health Condition 1: null- Painful Diabetic Peripheral Neuropathy
Conditions
Interventions
Intervention1: Combination of Diclofenac Sodium 1% with Triclocarban: Group A:
Apply Diclofenac Sodium 1% with Triclocarban, 3 times/day for 1 week +1 week wash out + Apply placebo, 3 times/day for 1
Sponsors
DrPrasad GM
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: •Able to read and understand the patient information sheet and informed consent form and voluntarily consent to participate in this study by signing the EC-approved patient information sheet and informed consent form •Males or females ages 18 â?? 75 years •Able to comply with the requirements of the protocol •Must have sufficient command and understanding of the English/ Tamil language to read and understand the patient information sheet and informed consent form as well as to complete diaries and questionnaires •Can be treated on an outpatient basis •Agree to be compliant with subject diary completion on a daily basis •Have Type I or Type II diabetes with a clinical diagnosis of diabetic distal symmetrical sensorimotor polyneuropathy and bilateral pain in the feet for at least 3 months •Have a stable diabetic treatment regimen, including oral medications for controlling diabetes, insulin, or diet for 3 months before screening, with hemoglobin A1C value of 10% or less •Have a mean score between 6.0 and 9.0, inclusive, on the 24-hour average pain intensity assessment on Days 1-6 and complete at least 15 of the18 pain assessments during the Run-In Phase •Subjects are permitted to take low dose aspirin and selective serotonin re-uptake inhibitors if they were kept on a stable dose for 30 days prior to the Screening Visit (Day 0) and are expected to remain on that dose throughout the study •ALT and AST •PT and PTT <= 1.5 x ULN
Exclusion criteria
Exclusion criteria: Exclusion Criteria •Have a significant neurological disorder or a condition that can cause symptoms that mimic peripheral neuropathy or might confound assessment of PDPN •Have an ulcer or non-intact skin in the area(s) where the study drug will be applied; or peripheral vascular disease (PVD) with absent foot pulses or with a history of amputation, except amputation of toes; or have extensive varicose veins on the lower extremities •Have any other significant pain condition with intensity at or greater than the bilateral pain in the feet/toes that could confound the assessment or self-evaluation of the neuropathic pain •Females who are pregnant or breast-feeding and/or plan to become pregnant or to breast-feed during study participation •Have a history of an unstable medical problem (renal function, heart failure, liver dysfunction, hypertension), clinically significant screening laboratory test or any current medical condition that would contraindicate the administration of the study drug, interfere with the study evaluations or interfere with the subjects ability to comply with the study •Have a prior history of gastric ulceration or gastrointestinal bleeding •Malignancy within the past 2 years •Known history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs •Current use of anticoagulants •Previous invasive intervention (e.g., spinal cord stimulator, intrathecal pump, or peripheral nerve stimulator) for pain relief related to PDPN •History of drug abuse or dependence (drug categories defined by DMS IV) within the past year, excluding nicotine and caffeine •Received any investigational drugs / treatments within 30 days prior to the Screening Visit •Injected anesthetics or steroid use within 30 days prior to the Screening Visit
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 60-minute post-administration pain rating in the morning compared to the pain rating immediately prior to that administrationTimepoint: change from baseline (mean score of the 24-hour average pain intensity assessment on days 1 - 6) to the average of the pain ratings during the 7-day treatment phases (treatment Phase I and treatment Phase II);Average of the last 3 days on treatment compared with baselineTimepoint: change from baseline (mean score of the 24-hour average pain intensity assessment on days 1 - 6) to the average of the pain ratings during the 7-day treatment phases (treatment Phase I and treatment Phase II);Percent of subjects achieving various levels of reduction in 24-hour average pain intensity score (derived from primary endpoint)Timepoint: change from baseline (mean score of the 24-hour average pain intensity assessment on days 1 - 6) to the average of the pain ratings during the 7-day treatment phases (treatment Phase I and treatment Phase II);Rescue medication use (number of days from first intake of double-blind study drug to first intake of rescue medication and the mean amount of rescue medication per study day will be derived)Timepoint: change from baseline (mean score of the 24-hour average pain intensity assessment on days 1 - 6) to the average of the pain ratings during the 7-day treatment phases (treatment Phase I and treatment Phase II);Responder rates (reduction of at least 30% or at least 50% compared with baseline based on the 11-point NRPS average pain score)Timepoint: change from baseline (mean score of the 24-hour average pain intensity assessment on days 1 - 6) to the average of the pain ratings during the 7-day treatment phases (treatment Phase I and treatment Phase II);Time to response (time in days to the first of 2 consecutive days after randomization with average pain score at least 2 points below baseline mean pain, based on the 11-point NRPS average pain score)Timepoint: change from baseline (mean score of the 24-hour averag | — |
Primary
| Measure | Time frame |
|---|---|
| Response to 11-point NRPS related pain intensity Timepoint: change from baseline (mean score of the 24-hour average pain intensity assessment on days 1 - 6) to the average of the pain ratings during the 7-day treatment phases (treatment phase I and treatment phase II) | — |
Countries
India
Contacts
Public ContactDrPrasad GM
Pranav Diabetes Center
Outcome results
None listed