CTRI/2021/08/035410RecruitingPhase 2
A Phase 2b, randomized, double-blind, placebo controlled dose-finding study to evaluate efficacy, safety and tolerability of GRC 17536 in patients with painful diabetic peripheral neuropathy.
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Glenmark Specialty SA
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •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 ââ?°Â¥4.
- •6. Moderate to severe pain due to DPN.
- •7. Treatment naÃ?¯ve subjects or subjects on treatment with DPN pain medication with pain not adequately controlled with the medication.
- •8. HbA1c (glycosylated hemoglobin) level ââ?°Â¤8%.
- •9. Must be willing to use appropriate contraceptive precautions as defined in the study protocol.
Exclusion Criteria
- •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) ââ?°Â¥1.5x upper limit of normal (ULN) or total bilirubin ââ?°Â¥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 ââ?°Â¥1.5x the ULN.
- •e) Creatinine clearance (CrCL) ââ?°Â¤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.
Investigators
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