A study to assess the effectiveness and safety of PL37 in reducing pain intensity when given in addition to gabapentin or pregabalin in patients suffering from neuropathic pain of diabetic origin, for whom ongoing treatment with gabapentin or pregabalin does not provide complete or sufficient relief of their neuropathic pain.

Phase 1

Conditions: europathic pain in diabetic patients
MedDRA version: 18.1Level: LLTClassification code 10067547Term: Diabetic peripheral neuropathic painSystem Organ Class: 100000004852
Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

Registration Number: EUCTR2013-004876-37-BG

Lead Sponsor: Pharmaleads SA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

Inclusion Criteria:
1. Willing and able to provide written informed consent prior to any study related procedures
2. Male or female, aged =18 years and =75 years
3. Willing to comply with all study procedures and be available for the duration of the study
4. Diagnosed (confirmed by pain specialist or endocrinologist) with peripheral neuropathic pain of diabetic origin
5. Neuropathic pain lasting for at least 3 months
6. Mean 24-hour average pain intensity score of 4 or higher, as calculated from a minimum of 5 NRS ratings recorded by the patient over the 7 days period after the screening and prior to the randomisation visit and also between the randomisation and the dispensing visit (this eligibility criterion will be provided by IVR system/ePRO diary)
7. Stable treatment with pregabalin or gabapentin for at least one month prior to screening visit
8. Adequately controlled diabetes (HbA1c =10% or 86 mmol/mol)
9. Women of reproductive potential must use highly effective contraception from screening to 1 week after end of study treatment. (A highly effective method of birth control is defined as one that results in a low failure rate (i.e., less than 1 percent per year) when used consistently and correctly, such as implants, injectable, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence, or a vasectomised partner)
10. Men of reproductive potential must use condoms from screening to 1 week after end of study treatment
11. HADS-Depression score = 11
12. Stable dose of any allowed central nervous system (CNS) - acting medications for at least one month prior to screening visit
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1. Unstable angina, heart failure and significant pulmonary disease requiring home oxygen
2. Severe renal disease defined as eGFR < 30 mL/min/1,73m2 calculated by using either the CKD-EPI or MDRD equation
3. Liver disease or any liver function test > 2.5 x ULN
4. Other painful medical conditions that could interfere with assessment of study outcomes (rheumatoid arthritis, inflammatory bowel disease, mechanical lower back disorders)
5. Use of disallowed concomitant medications (systemic analgesic, opioids or anti-inflammatory medications [other than paracetamol] or capsaicin cream during two weeks prior to screening visit)
6. Recent (last 2 weeks) febrile illness that precludes or delays participation
7. Inability to swallow study medication
8. Pregnant females as determined by positive urine pregnancy at randomisation visit
9. Breastfeeding females
10. Known hypersensitivity or intolerance to components of the study product(s)
11. Treatment with another investigational drug or other intervention during the last 4 weeks prior to screening visit
12. History of drug/alcohol abuse
13. History of severe psychiatric disorder
14. Anything that, in the opinion of the investigator, would place the subject at increased risk or preclude the subject’s full compliance with or completion of the study