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Efficacy of Pregabalin Vs Duloxetine in Diabetic Peripheral Neuropathic Pain at Variable Dose

Primary Purpose

Diabetic Peripheral Neuropathic Pain

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Duloxetine Tablets,
Pregabalin Tablets
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetic Peripheral Neuropathic Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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%

Exclusion Criteria:

  • 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Duloxetine Group

    Pregabalin Group

    Arm Description

    Oral intake Duloxetine tablets, 30mg/day for 12 weeks.

    Oral intake of Pregabalin tablets, 75 mg/day for 12 weeks.

    Outcomes

    Primary Outcome Measures

    visual analogue scale score.
    Evaluation perceived pain intensity by patients
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 9, 2022
    Last Updated
    August 3, 2022
    Sponsor
    Aga Khan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05292066
    Brief Title
    Efficacy of Pregabalin Vs Duloxetine in Diabetic Peripheral Neuropathic Pain at Variable Dose
    Official Title
    Efficacy of Variable Doses of Pregabalin Vs Duloxetine in Diabetic Peripheral Neuropathic Pain: A Comparative Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2022 (Anticipated)
    Primary Completion Date
    December 2022 (Anticipated)
    Study Completion Date
    December 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Aga Khan University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    This is prospective clinical research, that will be executed from Feb 2022 to May 2022, including, only those patients who are diagnosed with DPNP of at least six months duration, attending Rehman Medical Institute, General hospital. The diagnosis will be primarily clinical. Randomization of participants will be accomplished by registering the patients into any of two groups (Duloxetine group A, Pregabalin group B) using a statistical computer program. In group A (Duloxetine group) patients will receive duloxetine 30mg/day and group B (Pregabalin group) will receive Pregabalin 75 mg/day for upto 12 weeks. Biothesiometry will be performed for all diagnosed diabetic patients. Relevant clinical tests like HBA1c, Lipid profile, TSH, vitamin B12 levels will be performed in all patients before randomization. The sample size was calculated using an open epi sample size calculator using confidence interval 95%, power 80. Mean ±SD of Duloxetine group was 5.60 ±0.89. Mean ±SD of Pregabalin group was 6.01±0.82. Pregabalin group sample size was calculated to be 63 patients, Duloxetine group sample size was calculated to be 63 patients. Total number of participants was 126. Only, the approved procedures and protocols will be followed and all patients provided informed consent. Demographic profiles of volunteer participants like age, gender, living arrangements and others will be noted down. History of disease like duration and treatment for diabetes will be documented. Biothesiometer score above 15 volts will be considered as DNPN. Relevant investigations like HBA1c, Lipid profile, TSH, vitamin B12 levels will be performed in all patients before randomization. The criteria of classification for DPN will be done on the basis of the proposed TCSS score: zero to five points, without DPN; six to eight points, mild DPN; nine to 11 points, moderate DPN; and 12 to 19 points, severe DPN. The TCSS will be employed in people with type 2 diabetes to assess the prevalence of painful DPNP. A questionnaire (DN-4) will be used to evaluate the pain extent and the adverse effects related to duloxetine and pregabalin will be recorded in all cases. Toronto clinical neuropathy score (TCNS), consists of three parts: symptom scores, reflex scores, and sensory test scores. The maximum score is 19 points. Better pain relief will be the primary outcome of the proposed study which will be evaluated as a decrease in visual analogue scale (VAS) score. Written informed consent will be taken from each participant. Patients will be included in the study after informed consent and the patients have the right to withdraw from the trial at any point they want.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Peripheral Neuropathic Pain

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    126 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Duloxetine Group
    Arm Type
    Other
    Arm Description
    Oral intake Duloxetine tablets, 30mg/day for 12 weeks.
    Arm Title
    Pregabalin Group
    Arm Type
    Other
    Arm Description
    Oral intake of Pregabalin tablets, 75 mg/day for 12 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Duloxetine Tablets,
    Other Intervention Name(s)
    Cymbalta,
    Intervention Description
    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,
    Intervention Type
    Drug
    Intervention Name(s)
    Pregabalin Tablets
    Other Intervention Name(s)
    Lyrica.
    Intervention Description
    Pregabalin is an FDA approved, it is an anticonvulsant and anxiolytic medication used to treat epilepsy, neuropathic pain, fibromyalgia, restless leg syndrome,
    Primary Outcome Measure Information:
    Title
    visual analogue scale score.
    Description
    Evaluation perceived pain intensity by patients
    Time Frame
    3 months.
    Title
    Toronto clinical neuropathy score
    Description
    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.
    Time Frame
    3 months.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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% Exclusion Criteria: 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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dr. Fahim Ullah, MBBS, FCPS
    Phone
    03329142021
    Email
    drfaheemullah@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dr. Naseer Ahmed, MBBS, Phd
    Phone
    0333 3382013
    Email
    dr.naseer99@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Efficacy of Pregabalin Vs Duloxetine in Diabetic Peripheral Neuropathic Pain at Variable Dose

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