Health Condition 1: G892- Chronic pain, not elsewhere classified
Conditions
Interventions
Intervention1: GRC 17536: GRC 17536 (270 mg BID): 3 capsules of GRC 17536 (90 mg each capsule): in the morning and evening
orally for 12 weeks
Intervention2: GRC 17536: GRC 17536 (90 mg BID): 1 capsule of 90 mg GRC 17536 and 2 capsules of placebo: in the morning and in the evening
orally for 12 weeks
Intervention3: GRC 17536: GRC 17536 (30 mg BID): 1 capsule of 30mg GRC 17536 and 2 capsules of placebo: in the morning and in the evening
orally for 12 weeks
Control Intervention1: Placebo: 3 capsules of placebo in the morning and evening administered orally for 12 weeks.
Sponsors
Glenmark Specialty SA
Eligibility
Inclusion 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 â�¥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 â�¤8%. 9. Must be willing to use appropriate contraceptive precautions as defined in the study protocol.
Exclusion criteria
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) �1.5x upper limit of normal (ULN) or total bilirubin �1.2x ULN. b) Folate or Vitamin B12 levels 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in mean 24-hour API score as measured by 11-point NRSTimepoint: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events by type, severity, causality and seriousnessTimepoint: From Study initiation to end of study;Change from baseline in mean 24-hour API scoreTimepoint: Week 3, 6, 9, and 16;Change in mean night-time API scoreTimepoint: Week 3, 6, 9, 12, and 16;Change in mean night-time WPI scoreTimepoint: Week 3, 6, 9, 12, and 16;Change in mean sleep interference scoreTimepoint: Week 3, 6, 9, 12, and 16;Change in mean worst pain intensity (WPI) in last 24 hours [Time pointsTimepoint: Week 3, 6, 9, 12, and 16;Change in Neuropathic Pain Symptom Inventory (NPSI) scoreTimepoint: Week 6 and 12;Change in quality of life parameters as per SF-12 scoreTimepoint: Week 6 and 12;Cmax, Tmax, AUC, AUC0-tau, and AUC0-24 for GRC 17536.Timepoint: PK sampling time points: Day 3, 4, 7, 9, 15, 18, 25 and Day 29;Columbia-Suicide Severity Rating Scale (C-SSRS)Timepoint: From baseline to Week 12;Proportion of subjects achieving 30% reduction in the mean 24-hour API scoreTimepoint: Week 3, 6, 9, 12, and 16;Proportion of subjects achieving 50% reduction in the mean 24-hour API scoreTimepoint: Week 3, 6, 9, 12, and 16;Proportion of subjects who are responders on the Patient Global Impression of Change questionnaireTimepoint: Week 6, 12, and 16;Time to onset of sustained improvement in the 24-hour API scoreTimepoint: Day of onset of sustained improvement | — |
Countries
India
Contacts
Public ContactAmol Pendse
Glenmark Pharmaceuticals Ltd
Outcome results
None listed