CTRI/2020/12/029792已完成3 期
â??A Multicentric, Randomized, Double Blind, Parallel Group, Comparative, Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of FDC of Pregabalin SR 75 mg plus Mecobalamin 1500 mcg plus Nortriptyline 10 mg Tablets Versus FDC of Pregabalin SR 75 mg plus Methylcobalamin 1500 mcg Tablets in patients with diabetic peripheral neuropathic pain with coexistent Vitamin B12 deficiency.â??
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 210
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. Male or female patients aged between 18 and 65 years (both inclusive).
- •2. Patients with diagnosis of type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) <=11% and having pain associated with diabetic neuropathy for >= 6 months.
- •3. Patients total pain having intensity rating of at least 4 on a 0-10 points of numeric rating scale (NRS).
- •4. Patients with decreased Vitamin B12 levels ( < 200 pg per mL).
- •5. Patients with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
- •6. Patients willing to comply with the protocol requirements.
排除标准
- •1. Patients with hypersensitivity to either of the study medications or any of its components.
- •2. Patients with prior therapy with Pregabalin or Nortriptyline, and having any other neurologic disorders unrelated to diabetic neuropathy were excluded.
- •3. Patients with abnormal eGFR ( <60 mL/min/1.73 m2).
- •4. Patients with clinically significant impaired hepatic function. [SGOT & SGPT more than 2.5X the UNL and/or Total bilirubin more than 1.5X the UNL].
- •5. Patients with known case of HIV, Hepatitis B & C within previous 3 months.
- •6. Patients with clinical laboratory evaluations (including biochemistry and hematology) and 12 lead ECG readings are not within the reference range for the testing laboratory and the results are deemed clinically significant by the investigator.
- •7. Female patients who are pregnant or lactating or planning to become pregnant during the study period.
- •8. Females who are not ready to use acceptable contraceptive methods during the course of study.
- •9. Patients who, in the opinion of the investigator, have history of clinically significant cardiovascular disease (e.g. MI), central nervous system disorders (e.g. seizure, bipolar disorder, generalized anxiety disorder, untreated depression, psychosis or post-traumatic stress disorder), suicidal behavior, angle closure glaucoma, angioedema, urinary retention, thyroid disorder, uncontrolled hypertension.
- •10. Patients with known alcohol or other substance abuse within last one year.
- •11. Patients with medical history of Oncological Conditions since last 5 years.
- •12. Concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent.
- •13. Currently taking prohibited medications(s) listed and inability/unwillingness to discontinue them for the entire study period.
- •14. Participant has a clinically significant disorder that, in the opinion of the investigator, would result in the participantâ??s inability to understand and comply with the requirements of the study.
研究者
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