| CTRI Number |
CTRI/2010/091/001036 [Registered on: 22/07/2010] |
| Last Modified On: |
21/02/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Crossover Trial |
Public Title of Study
Modification(s)
|
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 |
Scientific Title of Study
Modification(s)
|
A randomized double blind Trial comparing Efficacy and Safety of Duloxetine vs. Amitriptyline in painful Diabetic Neuropathy |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 7778/PG-2Trg/2008/35-50-51 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Debasish Hota |
| Designation |
|
| Affiliation |
|
| Address |
Department of Pharmacology,
PN Chhuttani Block, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
01722755244 |
| Fax |
01722744401 |
| Email |
debhota@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Debasish Hota |
| Designation |
|
| Affiliation |
Assiociate Professor in Pharmacology |
| Address |
Department of Pharmacology,
PN Chhuttani Block, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
01722755244 |
| Fax |
01722744401 |
| Email |
debhota@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Debasish Hota |
| Designation |
|
| Affiliation |
|
| Address |
Department of Pharmacology,
PN Chhuttani Block, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
01722755244 |
| Fax |
01722744401 |
| Email |
debhota@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| 1. M/s. Sun Pharmaceuticals, Ahmedabad,
India
2. M/s. Wockhardt Ltd, Mumbai, India
3. PGIMER, Chandigarh |
|
Primary Sponsor
Modification(s)
|
| Name |
PGIMER |
| Address |
Sector-12
Chandigarh
160012 |
| Type of Sponsor |
Other [Post Graduate Institute Under Government of India] |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anil Bhansali |
Department of Endocrinology |
Nehru Hospital,PGIMER-160012
Chandigarh
CHANDIGARH |
0172-2756583
0172-2744401
anilbhansali_endocrine@rediffmail.com |
| Dr Harjot kaur |
Department of Pharmaology |
Room No. 4040,PGIMER-160012
Chandigarh
CHANDIGARH |
0172-2755244
0172-2744401
harjot_82@yahoo.co.in |
| Professor Amitava Chakrabarti |
Department of Pharmaology |
Room No. 4046,PGIMER-160012
Chandigarh
CHANDIGARH |
0172-2755242
0172-2744401
amitavachakrabarti315@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
PAINFUL DIABETIC NEUROPATHY, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
AMITRIPTYLINE |
10, 25, or 50 mg once daily. depending upon the quantum of pain control. Dose titration was made after weeks if needed |
| Intervention |
DULOXETINE |
To start with, 20mg/ day for two weeks was given. In case off inadequate response, the dose was increased to 40mg/day for another 2 weeks. If pain is still not controlled, the next higher dose 60 mg/day was given. In case, pain is well controlled the same dose of the drug was continued |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
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.
4. Neuropathic pain present for at least 1 month
5. Mean pain intensity of more than 50% by patient assessment by
VAS
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria
1. Age below 18 or above 75 years
2. 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 pregnancy
5. Evidence of other causes for neuropathy and painful conditions
6. Epilepsy, psychiatric and cardiac diseases, hypertensives not on
treatment,
peripheral vascular disease and substance abuse.
7. Intake of anticonvulsants, antidepressants, membrane
stabilizers and opioids
8. Participation in any other clinical trial with in the last 30 days
|
|
Method of Generating Random Sequence
Modification(s)
|
Permuted block randomization, fixed |
Method of Concealment
Modification(s)
|
Pre-numbered or coded identical Containers |
Blinding/Masking
Modification(s)
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| 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
Modification(s)
|
| Outcome |
TimePoints |
Comparison of the following scores between patients for painful diabetic neuropathy-
1. Short form McGill pain questionnaire
2. 11- point Likert scale for pain
3. Hamilton rating scale for depression
4. Adverse events
5. Quality of night time sleep
6. Patient preference of the drug
7. Patient Global Impression of Change (PGIC, 7-point scale).
|
baseline,2 4 6 weeks |
|
Target Sample Size
Modification(s)
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
17/11/2008 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Amitriptyline vs. pregabalin in painful diabetic
neuropathy: a randomized double blind clinical trial.Diabet. Med. 26, 1019–1026 (2009) |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
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. |