CTRI/2022/05/042521尚未招募4 期
A Phase IV, Multi-Centric Study to Evaluate Safety and Efficacy of Fixed Dose Combination of Pregabalin Prolonged Release and Etoricoxib Tablets in Patients Having Chronic Low Back Pain Associated with Neuropathic Component - NA
Sun Pharma Laboratory Limited SP0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
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 of either gender, aged 18 to 65 years (both inclusive) and ready to give written informed consent to participate in the study at the time of screening
- •2. Patients with chronic low back pain (symptoms duration: ââ?°Â¥ 3 months) and at least one of the following features on the side corresponding to leg pain:
- •a. Sharp and shooting pain below the knee;
- •b. Pain evoked by straight leg raising to 60 degrees or less;
- •c. Decreased or absent ankle reflex;
- •d. Weakness of muscles below the knee.
- •e. Sensory loss in L5/S1 distribution
- •3. Patients who have pain score of at least 4 on a Numeric Rating Scale (11- point)
- •4. Patients who agree not to use any other approved or experimental pharmacological treatments for low back pain, other than mentioned in the protocol, at any time during the study.
- •5. Women of childbearing potential must have a negative urine pregnancy test prior to study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till at least 7 days after the last dose of the study medication (such contraception may include hormonal birth control e.g., combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or total sexual abstinence)
- •[Note: Women with childbearing potential are defined as: those who are not (1) surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) or (2) post-menopausal. Post-menopausal woman will be defined as: Woman not using hormonal replacement therapy and have had at least 12 continuous months of natural (spontaneous) amenorrhea and be greater than 45 years of age.]
- •6. Patients willing to follow the study protocol
- •7. A male patient must agree to use adequate contraception from study entry till at least 7 days after the last dose of the study medication.
排除标准
- •1 Pregnant or lactating woman
- •2 Patients with history of HIV and/or HBV and/ or HCV
- •3 Anticonvulsants, antidepressants (e.g. tricyclic, tetracyclic, atypical), aspirin at doses >81 mg/day, benzodiazepines, opioids, herbal medications, mexiletine HCl, epidural injection and procedure (e.g. acupuncture) performed within 6 weeks prior to screening or planning to use during the study or taken more than recommended doses of any dosage form of NSAIDs analgesics in last 15 days prior to screening and any treatment for low back pain within 2 days prior to enrolment.
- •4 Patients who, in the opinion of the investigator, have history of/ or currently suffering with clinically significant conditions listed as below and not limited to:
- •Ã¢â?¬Â¢cardiovascular disease (e.g. MI, uncontrolled hypertension (ââ?°Â¥140 / 90 mmHg), New York Heart Association (NYHA) class II - IV); cerebrovascular disease (e.g. stroke)
- •Ã¢â?¬Â¢psychiatric disorders as per DSM-5 (Bipolar disorder, generalized anxiety disorder, depression, psychosis or post-traumatic stress disorder); epilepsy or seizure disorder requiring treatment with anti-epileptic drugs; suicidal behavior
- •Ã¢â?¬Â¢renal impairment (defined as either creatinine clearance < 60 mL/min or renal dysfunction requiring haemodialysis); hepatic impairment (Child-Pugh score > 6)
- •Ã¢â?¬Â¢respiratory depression; active peptic ulceration or active GI bleeding; inflammatory bowel diseases; peripheral arterial disease; neoplastic disease; lactose intolerance; angioedema, hypersensitivity reaction, thyroid disorder; and diabetes (HbA1c > 8% at screening)
- •Ã¢â?¬Â¢myopathy; blurred vision
- •5 Patients with any clinically significant lab abnormalities/ condition which in the opinion of investigator would compromise the well-being of the patient or the conduct of the study, or prevent the patient from meeting or performing study requirements.
- •6 Patients with tumorigenic potential as per investigatorââ?¬•s discretion
- •7 Patients with known alcohol or any substance abuse within last one year as per DSM-5 criteria
- •8 Pre-planned surgery or medical procedure that would interfere with the conduct of the study
- •9 Patients with history of hypersensitivity to any of the study drug or to drugs of similar chemical classes or to any of its excipients
- •10 Patients who has participated in another investigational study within 30 days prior to screening in this study or planning to participate during the study
- •11 Employee of the sponsor, investigator, or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees of sponsor or the investigator.
- •12 Patients operating heavy complex machinery or who intend to drive
研究者
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