Efficacy of Pregabalin Vs Duloxetine in Diabetic Peripheral Neuropathic Pain at Variable Dose
Efficacy of Variable Doses of Pregabalin Vs Duloxetine in Diabetic Peripheral Neuropathic Pain: A Comparative Study
1 other identifier
interventional
126
0 countries
N/A
Brief Summary
Background Diabetic neuropathy is a widespread, debilitating condition and its management needs a significant cost. Around, 50% of diabetes mellitus (DM) patients suffer from Diabetic Peripheral Neuropathic Pain (DPNP). According to the reported data, specific anticonvulsants and antidepressants are effective for coping diabetic peripheral neuropathy. Two drugs, duloxetine and pregabalin, are officially permitted by the Food and Drug Administration (FDA) for the management of DPNP. Methodology A Prospective Randomized Controlled Trial (RCT) trial for 12 weeks will be carried out on 126 volunteer DPNP patients with age between 18- to 70-year-old and participants was selected through consecutive sampling and will be evaluated on the basis of duration of the disease, pain scales and the data provided by particular consultants. The parameters will be measured weekly and final parameters will be measured after 12 weeks. Statistical analysis will be carried out by SPSS, ANOVA, and t-test. Expected outcomes: From this experimental design, investigators are expecting improvement in the management of DPNP and Duloxetine is more effective for treating patients suffering from DPNP.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Oct 2022
Shorter than P25 for early_phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2022
CompletedFirst Posted
Study publicly available on registry
March 23, 2022
CompletedStudy Start
First participant enrolled
October 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedAugust 4, 2022
August 1, 2022
2 months
February 9, 2022
August 3, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
visual analogue scale score.
Evaluation perceived pain intensity by patients
3 months.
Toronto clinical neuropathy score
Final diagnosis and staging of diabetic peripheral neuropathy of patients. Diabetes severity will be graded according to the results of this score. Out of a total score of 19, the grades are defined as follows: 0-5 = no neuropathy; 6-8 = mild neuropathy; 9-11 = moderate neuropathy; ≥ 12 = severe neuropathy.
3 months.
Study Arms (2)
Duloxetine Group
OTHEROral intake Duloxetine tablets, 30mg/day for 12 weeks.
Pregabalin Group
OTHEROral intake of Pregabalin tablets, 75 mg/day for 12 weeks.
Interventions
Duloxetine is an FDA-approved medication used to treat the major depressive disorder, generalized anxiety disorder, fibromyalgia, and neuropathic pain. It is taken by mouth. It is a serotonin-norepinephrine reuptake inhibitor. Pregabalin is an FDA approved, sold under the brand name Lyrica. it is an anticonvulsant and anxiolytic medication used to treat epilepsy, neuropathic pain, fibromyalgia, restless leg syndrome,
Pregabalin is an FDA approved, it is an anticonvulsant and anxiolytic medication used to treat epilepsy, neuropathic pain, fibromyalgia, restless leg syndrome,
Eligibility Criteria
You may qualify if:
- Both male and female patient with age more than 18 years to 70 years.
- Patients diagnosed with peripheral neuropathic pain affected by diabetes from at least 24 weeks and all other causes off peripheral painful neuropathy has been already excluded by their primary physician.
- Patients who may agree with written inform consent.
- HbA1c ≥ 6.5% and ≤ 10%
You may not qualify if:
- Patients with severe hepatic disease, cardiovascular diseases, Epilepsy and respiratory diseases or any other medical or psychiatric disorders.
- Patients with uncontrolled hypertension.
- DM patients with foot ulcers, foot injuries or any other painful lesion.
- Patients who are already using or used duloxetine or pregabalin in last three month.
- Pregnant women or those who may not agree to use medical recommended birth control procedures during the treatment.
- Patient with thyroid known disorders or diagnosed during the screening
- Vitamin B12 deficient patient
- Chronic alcoholics
- DKD, with eGFR \< 30ml/min
- Hypertriglycedmia (TGs more then 250mg/dl)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Fahim Ullah, Assistant professor.
Study Record Dates
First Submitted
February 9, 2022
First Posted
March 23, 2022
Study Start
October 1, 2022
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
August 4, 2022
Record last verified: 2022-08