Health Condition 1: G938- Other specified disorders of brain
Conditions
Interventions
Intervention1: Fixed Dose Combination of Gabapentin + Duloxetine Capsule: Test Product (T1) Fixed Dose Combination of Gabapentin 200 mg + Duloxetine 20mg capsule
frequency: Combination of gabapentin
Sponsors
Mr Surender Arora
Synokem Pharmaceuticals Ltd
Eligibility
Inclusion criteria
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 newly diagnosis of Neuropathic pain (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 Neuropathic 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.
Exclusion criteria
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 Neuropathic 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) 13. Patient with known alcohol or other substance abuse as per treating physician discretion within last one year from screening or patient who consume alcohol during the surveillance, which in the opinion of the investigator will impact patient’s treatment evaluation and safety during surveillance. 14. History of HIV, HBV, HCV 15. History of any acute/chronic stokes, heart failures and relevant cardiac diseases. 16. Hypercreativity of the study drug. 17. Patients already using any other medication for pain relief like PCM/ NSAIDS /opioids etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in Pain Intensity as assessed by VASTimepoint: Baseline, Treatment Visit Week 4 and EOT or EOS Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| By the type, number, frequency & proportion of patients with Adverse Event(s).Timepoint: Baseline Treatment Visit Week 4 & EOT or EOS Week 8;Mean change in Allodynia (pain due to a stimulus that does not normally cause pain, e.g., stroking) as assessed by VAS.Timepoint: Baseline Treatment Visit Week 4 & EOT or EOS Week 8;Mean change in Hyperalgesia (severe pain due to a stimulus that normally causes slight pain, e.g., a pinprick) as assessed by VAS. Timepoint: Baseline Treatment Visit Week 4 & EOT or EOS Week 8;Pain disability index scoreTimepoint: Baseline Treatment Visit Week 4 & EOT or EOS Week 8 | — |
Countries
India
Contacts
Public ContactUmakant Ghodke
Synergen Bio Private Limited
Outcome results
None listed