CTRI/2020/09/027555已完成3 期
A Phase III Randomized, Multi-centric, Double-blind, Doubledummy,Parallel-group Non-inferiority Study to Evaluate Efficacyand Safety of Fixed Dose Combination of Pregabalin and DuloxetineCapsule compared to Monotherapy of Pregabalin Capsule in Patientswith Moderate to Severe Neuropathic Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 328
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
排除标准
- •1. Patients with a history of hypersensitivity to pregabalin or duloxetine or any of its
- •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 < 130 mmol/L at screening.
- •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.
研究者
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