A study of oral GRC 17536 in treatment of painful diabetic peripheral neuropathy to find an effective dose of GRC 17536 to reduce the level of pai
- Conditions
- Health Condition 1: G892- Chronic pain, not elsewhere classified
- Registration Number
- CTRI/2021/08/035410
- Lead Sponsor
- Glenmark Specialty SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Each subject must meet all of the following criteria to be randomized in the study:
1. Subject voluntary willing to provide written informed consent; and willing to comply with all aspects of the protocol.
2. Type 1 or Type 2 diabetes mellitus male and female (post-menopausal/surgically sterile females only) subjects with age between 18 and 75 years (inclusive of both) at the time of informed consent.
3. A history of pain for at least 6 months and no greater than 5 years attributed to DPN.
4. Subjects with cold detection and warm detection present.
5. Douleur Neuropathique en 4 questions (DN4) score �4.
6. Moderate to severe pain due to DPN.
7. Treatment na�¯ve subjects or subjects on treatment with DPN pain medication with pain not adequately controlled with the medication.
8. HbA1c (glycosylated hemoglobin) level �8%.
9. Must be willing to use appropriate contraceptive precautions as defined in the study protocol.
A subject who meets any of the following criteria must not be entered into the run-in phase/randomized in the study:
1. Other chronic pain conditions not associated with DPN that may confound the assessment of pain in DPN.
2. Use of a capsaicin patch within 6 months prior to Screening.
3. Subjects who are currently taking opioids for their painful DPN.
4. Recent hospitalization due to hypo or hyperglycemia within the last 3 months prior to the Screening Visit.
5. Complex regional pain syndrome or trigeminal neuralgia.
6. Active diabetic foot ulcer.
7. Subject has any of the following laboratory abnormalities, medical conditions, or disorders:
a) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or alkaline phosphatase (ALP) �1.5x upper limit of normal (ULN) or total bilirubin �1.2x ULN.
b) Folate or Vitamin B12 levels < lower limit of normal (LLN).
c) Chronic hepatitis B or C with a positive Hepatitis B surface antigen (HBsAg) or Hepatitis C Core Antigen Antibody (Hep C antibody).
d) Blood urea nitrogen �1.5x the ULN.
e) Creatinine clearance (CrCL) �60 mL/min as determined by the central laboratory using the modified Cockcroft-Gault equation.
j) SARS-CoV2 infection within 4 weeks before Screening and any persisting post-infection symptoms at the time of Screening.
11. Current diagnosis of major depression or taking medications for it.
12. Presence or history of cancer within the past 5 years
13. Subjects who have undergone gastrointestinal surgery that could affect the absorption of investigational product (e.g., bariatric surgery).
14. Subjects with a history of human immunodeficiency virus (HIV) infection.
15. Subject is positive for urine opioid/cannabinoid tests.
16. History of alcohol abuse/dependence as assessed by the Investigator.
17. Participants answering Yes to any of the questions about active suicidal ideation/intent/behaviors occurred within the past month.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in mean 24-hour API score as measured by 11-point NRSTimepoint: Week 12
- Secondary Outcome Measures
Name Time Method