| CTRI Number |
CTRI/2010/091/001458 [Registered on: 15/10/2010] |
| Last Modified On: |
12/03/2013 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical trial to study the efficacy and safety of topical gel containing fixed dose combination of Amitriptyline, Lidocaine and Capsaicin in treatment of neurogenic pain associated with localized peripheral neuropathies. |
Scientific Title of Study
Modification(s)
|
A open-label, multicenter, non-randomized, prospective, phase III clinical trial to study the Efficacy and Safety of topical gel containing fixed dose combination of Amitriptyline, Lidocaine and Capsaicin in treatment of neurogenic pain associated with localized peripheral neuropathies. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| LPL/ARCCP/06/10/ALC |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Sanjiv Shah |
| Designation |
|
| Affiliation |
|
| Address |
Diabetes Action Centre
1, Sameer Apartment, Mathuradas Road, Kandivli (West), .
Mumbai
MAHARASHTRA
400 067
India |
| Phone |
9820196066 |
| Fax |
022-28629176 |
| Email |
diabetesmumbai@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Alok Chaturvedi |
| Designation |
|
| Affiliation |
|
| Address |
Laxmi Tower, ‘C’ wing, 4th floor,
Bandra Kurla Complex, Mumbai-400051
Laxmi Tower, ‘C’ wing, 4th floor,
Bandra Kurla Complex, Mumbai-400051
Mumbai
MAHARASHTRA
400051
India |
| Phone |
022-66402200 |
| Fax |
022-66402207 |
| Email |
alokchaturvedi@lupinpharma.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Alok Chaturvedi |
| Designation |
|
| Affiliation |
|
| Address |
Laxmi Tower, ‘C’ wing, 4th floor,
Bandra Kurla Complex, Mumbai-400051
Laxmi Tower, ‘C’ wing, 4th floor,
Bandra Kurla Complex, Mumbai-400051
Mumbai
MAHARASHTRA
400051
India |
| Phone |
022-66402200 |
| Fax |
022-66402207 |
| Email |
alokchaturvedi@lupinpharma.com |
|
Source of Monetary or Material Support
Modification(s)
|
|
Primary Sponsor
Modification(s)
|
| Name |
Lupin Limited India |
| Address |
Laxmi Tower, ‘C’ wing, 4th floor,
Bandra Kurla Complex, Mumbai-400051
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. K.A. Narsikar |
JN-2 /47 /P-2 , |
Sector 9,,Vashi, -400 705
Mumbai
MAHARASHTRA |
9869839770
|
| Dr. A. Moralwar |
Moralwar day care center |
Sector 1-A, ,Sector 1-A, -400 612
Mumbai
MAHARASHTRA |
9819951868
|
| Dr. R.D. Walinkar |
Shop No. 8, Shalom, |
Sector 16 A,,Vashi- 400 705
Mumbai
MAHARASHTRA |
9869251454
|
| Dr. W. R. Patil |
Shree Polyclinic |
114, Nirman Vyapar Kendra, Sector-17,Vashi, -400 705
Mumbai
MAHARASHTRA |
9820447568
|
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee |
Approved |
| Independent Ethics Committee |
Approved |
| Independent Ethics Committee |
Approved |
| Independent Ethics Committee |
Approved |
| Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Localized peripheral neuropathies, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Topical gel containing fixed dose combination of Amitriptyline, Lidocaine and Capsaicin |
Topical gel containing FDC of
Amitriptyline hydrochloride (2.0%),
Lidocaine hydrochloride (2.5%) and
Capsaicin (0.075%)
2-3 times a day for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
1.Male and Female patients with age more than 18 years.
2.Written informed consent signed by patient and willing to comply with the study procedure.
3.Patients with established diagnosis of neurogenic pain associated with localized peripheral neuropathies (e.g. Post herpetic neuralgia, Diabetic neuropathy, Post-surgical/ traumatic neuropathic pain.).
4.Presence of dynamic tactile allodynia or pinprick hyperalgesia in the area of pain.
5.Except neurogenic pain and diseases associated with it patient is judged to be in general good health based on medical history and physical examination.
6.In case of woman of childbearing potential willing to use effective contraception during the study and willing to undergo pregnancy test.
7.Patients having pain rating of at least 4 on a VAS of 0?10.
8.Concurrent stable doses of orally non-opioid, opioid, and analgesics are allowed (including antidepressants or anticonvulsants).
|
|
| ExclusionCriteria |
| Details |
1.Patients with age less than 18 years.
2.Pregnant and lactating women patients.
3.Women of childbearing potential who are not willing to use effective contraception during the study and not willing to undergo pregnancy test.
4.Patients not willing to comply with the study protocol and provide written informed consent to participate.
5.Participation in a clinical trial with an investigational product within 90 days preceding day one of this study.
6.Patients with known history of cardiac failure, orthostatic hypotension, narrow angle glaucoma, renal and liver impairment or any other condition that in the judgment of the investigator not suitable to be enrolled in the study.
7.Patients having history of any other type of pain as severe as the pain under study.
8.Patients having history of any other type of neurogenic pain not included in the study.
9.Patients having skin disease, breakdown, infection, or extreme thinning at the site of pain.
10.Patients with known hypersensitivity to Amitriptyline / Lidocaine / Capsaicin.
11.Patients with history of using topically applied Amitriptyline / Lidocaine / Capsaicin and corticosteroids on the painful area.
12.Concurrent class I antiarrhythmic drugs (eg, tocainide or mexiletine). |
|
Method of Generating Random Sequence
Modification(s)
|
Not Applicable |
Method of Concealment
Modification(s)
|
Not Applicable |
Blinding/Masking
Modification(s)
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Mean change in Pain Intensity as assessed by VAS
Mean change in Allodynia (pain due to a stimulus that does not normally cause pain, e.g., stroking) as assessed by VAS
Mean change in Hyperalgesia (severe pain due to a stimulus that normally causes slight pain, e.g., a pin-prick) as assessed by VAS
Pain disability index score
Investigator?s and Patient?s Global assessment of the treatment on 14th Day
|
0,2nd,3rd and 4th Weeks |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
By the type, number, frequency and proportion of patients with Adverse Event(s)
Concomitant medication (to be taken to overcome any adverse events) if any
|
2nd,3rd and 4th Weeks |
|
Target Sample Size
Modification(s)
|
Total Sample Size="220"
Sample Size from India="220"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
15/10/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
15/10/2010 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
trial not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This will be phase III, multicenter, open-label, non-randomized, prospective study involving 220 patients having neurogenic pain associated with localized peripheral neuropathies receiving topical gel containing fixed dose combination of Amitriptyline, Lidocaine and Capsaicin (Investigational Product) 2-3 times a day for 4 weeks.The treatment period will be for 4 weeks and patients may be monitored on 2nd, 3rd and 4th weeks of the trial. Patient will undergo physical examination, systemic examination, vital examination; Pregnancy test (If required) and Base line assessment including Visual Analog Scale (VAS) for pain intensity, allodynia, hyperalgesia and pain disability index score will be assessed. A record of adverse events and use of concomitant medication (to be taken to overcome any adverse events) if any will be assessed. Efficacy of investigational product will be assessed. |