Diabetic Peripheral Pain Coexisting with Vitamin B12 deficiency to treat with FDC of Pregabalin plus Methylcobalamin plus Duloxetine (Delayed Release) Capsules.

Phase 3

Recruiting

• Conditions: Type 2 diabetes mellitus with neurological complications,

• Registration Number: CTRI/2024/01/062147
• Lead Sponsor: Ravenbhel Healthcare Pvt. Ltd.

Brief Summary

Neuropathic Pain (NP) is a common complication of diabetes, affecting 30-50% of patients. Management is challenging due to insufficient therapeutic options. Pregabalin is effective for NP relief, and a combination of Pregabalin or Gabapentin with TCAs or SNRIs is now recommended. Combination therapy using two drugs with different mechanisms of action is beneficial in pain medicine.

Pregabalin binds to calcium channels in the central nervous system, potentially modulating pain transmission by reducing calcium influx and inhibiting excitatory neurotransmitters.

The study involves subjects taking a combination of Pregabalin 75 mg plus Methylcobalamin 1500 mcg plus Nortriptyline 10 mg Tablet and Matching Placebo Capsule, either in the Test or Reference arm. The medication is taken orally every night before sleep. The study will last for 14 weeks, with the duration of the medication being 84 ± 2 days.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-15
• Last Update Posted: 2024-12-04

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• 1.Male or Female subjects between 18 to 75 years of age (both inclusive).
• 2.Subjects with a diagnosis of type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) ≤12% and having pain associated with diabetic peripheral neuropathy≥ 3 months.
• 3.Subjects with pain intensity ≥ 4 on 0-10 points of visual analog scale (VAS).
• 4.Subjects with decreased vitamin B12 levels (< 200 pg/mL) at screening visit.
• 5.Subjects who are willing to sign written informed consent for participation in the study.
• 6.Subjects willing to adhere to all protocol procedures.

Exclusion Criteria

• 1.Subjects with hypersensitivity to either of the study medications or any of the ingredients of the formulation.
• 2.Patients with prior therapy with Pregabalin or Duloxetine or Nortriptyline and having any other neurologic disorders unrelated to diabetic peripheral neuropathic pain were excluded.
• 3.Patients with clinically significant impaired hepatic function.
• [SGOT & SGPT more than 3X the UNL and/or Total bilirubin more than 1.5X the UNL].
• 4.Subject with abnormal eGFR (<60 mL/min/1.73 m2).
• 5.Subjects with Serum creatinine more than 1.5X the ULN.
• 6.Patients with any abnormality on 12 lead ECG readings and the results are deemed clinically significant by the investigator.
• 7.Subjects with a history of HIV, Hepatitis B & C.
• 8.Female patients who are pregnant or lactating or planning to become pregnant during the study period.
• 9.Females who are not ready to use acceptable contraceptive methods during the course of study.
• 10.Subjects who, in the opinion of the investigator, have a history of clinically significant cardiovascular disease (e.g. MI), subjects who are on pacemakers, central nervous system disorders (e.g. seizure, bipolar disorder, generalized anxiety disorder, untreated depression, psychosis or post-traumatic stress disorder), suicidal behavior, glaucoma, angioedema, urinary retention, thyroid disorder, uncontrolled hypertension, bleeding disorders.
• 11.Subjects with history of suicidal thoughts and behavior.
• 13.Subjects with uncontrolled hypertension with sitting SBP ≥ 160 mmHg and/or DBP ≥ 100 mmHg at screening.
• 14.Patient treated with topical or systemic pain medications within past 2 weeks prior to baseline.
• 15.Subjects with known alcohol or other substance abuse.
• 16.Subjects with a medical history of Oncological Conditions.
• 17.Concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent.
• 19.Participant has a clinically significant disorder that, in the opinion of the investigator, would result in the participant’s inability to understand and comply with the requirements of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change in visual analog scale (VAS) from baseline to end of the treatment. (12 weeks)	12 weeks

Secondary Outcome Measures

Name	Time	Method
Change in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale from baseline to end of treatment. (12 weeks).	Change in the Patient global impression of change scores (PGIC) from baseline to end of the treatment. (12 Weeks).

Trial Locations

Locations (10)

Aatman Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Arghya Neurolgy Clinic; 🇮🇳 Pune, MAHARASHTRA, India

Government Medical College and Govt. General Hospital (Old RIMSGGH); 🇮🇳 Srikakulam, ANDHRA PRADESH, India

King George Hospital; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

Lifeline Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Motilal Nehru Medical College; 🇮🇳 Allahabad, UTTAR PRADESH, India

Neurodent Superspeciality Clinic; 🇮🇳 Pune, MAHARASHTRA, India

Nil Ratan Sircar Medical College; 🇮🇳 Kolkata, WEST BENGAL, India

Rising Medicare Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Tulsi Hospital India Ltd.; 🇮🇳 Nagar, UTTAR PRADESH, India

Aatman Hospital

🇮🇳Ahmadabad, GUJARAT, India

Dr Chintan B Patel

Principal investigator

9825182251

drchintan.cr@gmail.com