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.

Phase 3

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

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).

Exclusion Criteria

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).

Primary Outcome Measures

Name	Time	Method
Mean change in Pain Intensity as assessed by VAS	0,2nd,3rd and 4th Weeks
Mean change in Allodynia (pain due to a stimulus that does not normally cause pain, e.g., stroking) as assessed by VAS	0,2nd,3rd and 4th Weeks
Mean change in Hyperalgesia (severe pain due to a stimulus that normally causes slight pain, e.g., a pin-prick) as assessed by VAS	0,2nd,3rd and 4th Weeks
Pain disability index score	0,2nd,3rd and 4th Weeks
Investigator?s and Patient?s Global assessment of the treatment on 14th Day	0,2nd,3rd and 4th Weeks

Secondary Outcome Measures

Name	Time	Method
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

Locations (4): JN-2 /47 /P-2 ,
🇮🇳
Mumbai, MAHARASHTRA, India
Moralwar day care center
🇮🇳
Mumbai, MAHARASHTRA, India
Shop No. 8, Shalom,
🇮🇳
Mumbai, MAHARASHTRA, India
Shree Polyclinic
🇮🇳
Mumbai, MAHARASHTRA, India
JN-2 /47 /P-2 ,
🇮🇳Mumbai, MAHARASHTRA, India
Dr. K.A. Narsikar
Principal investigator
9869839770