Health Condition 1: M792- Neuralgia and neuritis, unspecified
Conditions
Interventions
Intervention1: Test product-Fixed dose combination (FDC) capsule of Pregabalin
and Duloxetine, Dummy of Test Product: Test product-Fixed dose combination (FDC) capsule of Pregabalin
and Duloxetine
T1
Sponsors
Torrent Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients willing to give written informed consent to participate in the study 2. Male and female subjects aged 18-65 years (both inclusive) 3. Treatment naïve patients with moderate to severe neuropathic pain (e.g., post herpetic neuralgia, diabetic neuropathy, small fiber neuropathy or idiopathic distal sensory polyneuropathy) 4. Patient having at least moderate to severe pain intensity greater than or equal to 4 on Numeric Pain Rating Scale (NPRS) at screening and enrollment 5. WOCBP must have negative serum pregnancy test at screening and negative urine pregnancy test at baseline. All female subjects will be considered to be of childbearing potential unless they are postmenopausal. Female subjects of childbearing potential (WOCBP) are defined as sexually mature women without prior hysterectomy, or who have had any evidence of menses in the past 12 months. However, women who have been amenorrheic for the past 12 or more months are still considered to be of childbearing potential, if the amenorrhea is possibly due to other causes, including prior chemotherapy, antiestrogens, or ovarian suppression. Postmenopausal women (defined as women who have been amenorrheic for at least 12 consecutive months, in the appropriate age group, without other known or suspected primary cause) or women who have been sterilized surgically or who are otherwise proven sterile (i.e., total hysterectomy, or bilateral oophorectomy with surgery at least 4 weeks prior to randomization) are not considered WOCBP. Subjects who have undergone tubal ligation are NOT considered as surgically sterile.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of hypersensitivity to pregabalin or duloxetine or any of its excipients 2. Patient having history of suicidal thoughts and behavior 3. Patient having history of clinically significant medical illness in past 3 months, such as cardiovascular disease (e.g., MI, uncontrolled hypertension, orthostatic hypotension), falls and syncope, central nervous system diseases (e.g., seizure, bipolar disorder, depression, generalized anxiety disorder), liver disease, angioedema, peripheral edema, angle-closure glaucoma, urinary retention, bleeding disorder or any other disorder which may compromise safety of patient as per investigator discretion 4. Patient having history of type I or II diabetes with glycosylated hemoglobin A1c of greater than or eual to 10% at screening 5. Patients with clinically significant ECG abnormalities or QTc graeter than or equal to 450 msec at screening. 6. Patient having creatinine clearance less than or equal to 60 ml/min or known case of renal impairment 7. Patients with liver enzymes, ALT or AST > 3X, ALP > 2.5X of ULN (upper limit of normal) or total bilirubin >1.5X of ULN at screening. 8. Patient having serum sodium level 9. Patients treated with drugs that impair metabolism of serotonin (mono-amine oxidase inhibitors, linezolide, methylene blue) or serotonergic agents other than study drugs (SSRIs, SNRIs, triptans, antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines) or corticosteroids within past 4 weeks prior to screening. 10. Patient treated with topical or systemic pain medications (e.g., NSAIDs, local anesthetics, methyl salicylate, capsaicin, tramadol, tapentadol etc.) within past 2 weeks prior to basel11. History of drug abuse or known active alcohol abuse within past 6 months. Note: Use of benzodiazepines for medical reason will be allowed if the patient is taking stable dose of the same for at least 4 weeks prior to screening. 12. Pregnant or lactating women 13. Female subjects who are of childbearing potential and who are neither surgically sterilized nor willing to use medically acceptable contraceptive methods (sexual abstinence, hormonal, barrier methods or intrauterine device) during the study 14. Patients participated in any other investigational drug trial within the past four weeks prior to screeningine. 15. In the opinion of the investigator, patient is either unable to cooperate or unlikely to adhere with any study procedures or not considered suitable candidate for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in Numeric Pain Rating Scale (NPRS) scoreTimepoint: from baseline to end of the treatment (week 7) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Mean change in Numeric Pain Rating Scale (NPRS)Timepoint: Mean change in Numeric Pain Rating Scale (NPRS) from baseline to week 2, 3 and 5.;Clinical global impression of improvement (CGI-I) at end of the treatmentTimepoint: Clinical global impression of improvement (CGI-I) at end of the treatment (week 7).;Incidence of treatment emergent adverse events [dizziness, somnolence &/or peripheral edema] in test arm against reference arm.Timepoint: NA;Mean change in Neuropathic Pain Symptom Inventory (NPSI) total score from baseline to end of the treatmentTimepoint: Mean change in Neuropathic Pain Symptom Inventory (NPSI) total score from baseline to end of the treatment (week 7).;Patient global impression of improvement (PGI-I) at end of the treatment.Timepoint: Patient global impression of improvement (PGI-I) at end of the treatment (week 7).;Percentage of patients who required rescue medication for inadequate pain reliefTimepoint: NA;Proportion of patients with grater than or equal to 50% improvement in NPRS from baseline to end of the treatmentTimepoint: Proportion of patients with grater than or equal to 50% improvement in NPRS from baseline to end of the treatment (week 7).;Proportion of responders (greater rthan or equal to 30% improvement in pain (NPRS) from baseline to end of the treatmentTimepoint: Proportion of responders (greater rthan or equal to 30% improvement in pain (NPRS) from baseline) at end of the treatment (week 7). | — |
Countries
India
Contacts
Public ContactDr sanjay Sharma
Torrent Pharmaceuticals Ltd, Research Centre
Outcome results
None listed