Treatment of nerve pain in patients with diabetes with a capsaicin (chilli pepper) patch (skin plaster).

Phase 1

Conditions: Diabetic painful neuropathy
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2017-004746-17-GB

Lead Sponsor: Joint Research Compliance Office, Imperial College London and Imperial College Healthcare NHS Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 50

Inclusion Criteria

1. Participants aged 18-80 years with painful distal, symmetrical, sensorimotor
polyneuropathy due to type 2 Diabetes of at least 1-year duration.
2. Stable control for at least 3 months of type 2 Diabetes mellitus.
3. Glycosylated haemoglobin (hbA1c) of = 9%.
4. Willing to provide written informed consent to participate in the study.
5. Patients with a history of pain intensity equal or greater than 4 NPRS points (as
determined by the NPRS study diary at baseline) are eligible to participate.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

1. Non-diabetic neuropathies
2.History of alcohol/substance abuse
3.History of severe psychiatric illnesses
4.Pregnancy/breast feeding or planning pregnancy during the course of the study
5.Significant renal impairment (eGFR <30mL/minute/1.73m2)
6.Heart failure New York Heart Association (NYHA) = class II
7.Any other painful medical conditions that may interfere with the assessment
of change in neuropathic pain.

In addition to the exclusion criteria above patients who are participating in another clinical trial or who have done so within 30 days before screening will be considered as not eligible for the study.