A clinical trial to study and compare the effects of two drugs amitriptyline and duloxetine in patients with type 2 diabetes mellitus with neuropathic pain

Phase 4

Completed

Conditions: PAINFUL DIABETIC NEUROPATHY

Registration Number: CTRI/2010/091/001036

Lead Sponsor: PGIMER

Brief Summary: Painful peripheral diabetic neuropathy is a chronic complication of diabetes characterized by intractable pain, which mainly affects the foot. The currently available treatments have their own limitations. A randomized, double blind, active control, cross over clinical trial with optional dose up-titration to compare the efficacy and safety of duloxetine with amitriptyline in controlling peripheral neuropathic pain was conducted. Though 76 patients were included, 65 were randomized and only 58 reported after taking at least one dose of the treatment. The pain relief was observed in 80% and 79% patients on amitriptyline and duloxetine respectively by Visual analogue scale. Patient global assessment, McGill pain questionnaire and Likert pain scale showed significant improvement with both treatments from second week itself. Amitriptyline and duloxetine showed more than 50% relief in pain in 56% and 58% respectively. However, not much improvement in other symptoms like numbness and paraesthesia could be achieved. Adverse events were more observed for amitriptyline. Most patients preferred amitriptyline dose 25mg once daily and duloxetine was preferred as 60 mg once daily at bedtime. Although both drugs showed comparable efficacy, of the two therapies duloxetine was preferred over amitriptyline due to its better tolerable adverse effect profile. There were self reported events of constipation and uneasiness noticed with duloxetine compared to dry mouth, sedation, dizziness and uneasiness while on amitriptyline. Comparing the efficacy and safety of the two drugs, duloxetine emerges as a better alternative due to comparable efficacy and a more tolerable adverse event profile. However, the cost may be the limiting factor and needs to be considered, especially in patients tolerable to amitriptyline.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

Inclusion criteria 1.
Presence of type 2 diabetes mellitus 2.
No change in anti-diabetic medication for the last 1 month 3.
Evidence of diabetic neuropathy by Diabetic Neuropathy Symptom Score >1 point, Diabetic Neuropathy Examination Score >4 point, Vibration perception test and monofilament test.
Neuropathic pain present for at least 1 month 5.
Mean pain intensity of more than 50% by patient assessment by VAS.

Exclusion Criteria

Exclusion criteria1.
Age below 18 or above 75 years2.
Evidence of renal disease (Se. creatinine > 1.5)3.
Evidence of liver disease (deranged LFT with clinical evidence)4.
Pregnant and lactating mothers and women intending pregnancy5.
Evidence of other causes for neuropathy and painful conditions6.
Epilepsy, psychiatric and cardiac diseases, hypertensives not on treatment, peripheral vascular disease and substance abuse.7. Intake of anticonvulsants, antidepressants, membrane stabilizers and opioids8.
Participation in any other clinical trial with in the last 30 days.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients showing improvement by patient assessment of efficacy by visual analogue scale was done. This was compared between the two treatment groups.	Baseline (0), 2,4 6 weeks

Secondary Outcome Measures

Name	Time	Method
Comparison of the following scores between patients for painful diabetic neuropathy-	1. Short form McGill pain questionnaire

Trial Locations

Locations (2): Department of Endocrinology
🇮🇳
Chandigarh, CHANDIGARH, India
Department of Pharmaology
🇮🇳
Chandigarh, CHANDIGARH, India
Department of Endocrinology
🇮🇳Chandigarh, CHANDIGARH, India
Dr Anil Bhansali
Principal investigator
anilbhansali_endocrine@rediffmail.com