Efficacy and Safety of Mirogabalin in Diabetic Peripheral Neuropathic Pain
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40+
SponsorBangladesh Medical University
About this trial
The goal of this clinical trial is to learn if drug Mirogabalin works to treat diabetic peripheral neuropathic pain in adults. It will also learn about the safety of the drug Mirogabalin. The main questions it aims to answer are:
Does drug mirogabalin reduce neuropathic pain intensity? Is the drug mirogabalin safe in patients with diabetes suffering from neuropathic pain? Does drug mirogabalin improve patients' quality of life (QoL) ( physical, mental, and social well-being)? Researchers will compare drug mirogabalin to drug pregabalin (a drug conventionally used to treat diabetic neuropathic pain) to see if drug mirogabalin works to treat, safe and improve quality of life (QoL) in diabetic neuropathic pain.
Participants will:
Take drug Mirogabalin or pregabalin every day for 8 weeks Visit the clinic at 1, 2, 4, 6, 8 weeks for checkups
Eligibility criteria
Qualifiers
Adults (≥40 years) with diabetic neuropathy (Toronto score ≥6).
Persistent pain (NPS) despite standard therapy.
Stable diabetes management (HbA1c ≤8.5%).
Disqualifiers
History of drug allergy to gabapentinoids.
Concurrent use of opioids or other neuropathic pain medications.
Pregnancy or lactation.
Cancer pain
Trial design
Treatments tested in this trial
- Mirogabalin
- Pregabalin
Treatment groups
78 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov