A Prospective, Multi-Center, Double blind, Comparative, Active-Controlled, Parallel Group, Randomized Study to Evaluate the Efficacy and Safety of Fixed Dose Combination (FDC) of Pregabalin ER 82.5mg and Polmacoxib 2mg compared to Pregabalin 75 mg and Etoricoxib 60mg in Indian Adult Patients with Chronic Lower Back Pain.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 228
- 试验地点
- 9
- 主要终点
- Change in Mean Numeric Pain Rating Scale (NPRS) levels
研究概览
简要总结
This is a Prospective, Multi-Center, Double blind, Comparative, Active-Controlled, Parallel Group, Randomized Study to Evaluate the Efficacy and Safety of Fixed Dose Combination (FDC) of Pregabalin ER 82.5mg and Polmacoxib 2mg compared to Pregabalin 75 mg and Etoricoxib 60mg in Indian Adult participants with Chronic Lower Back Pain. Adult male or female participants aged of 18-65 years with chronic low back pain (symptoms duration greater than or equal to 3 months) will be enrolled into the study. The study will consist of up to14-days screening period, 8 weeks treatment period. Approximately 228 patients will be randomized into either Test arm or Comparator arm. Participants will receive either Hetero Fixed Dose Combination (FDC) of Pregabalin ER 82.5mg and Polmacoxib 2mg or Reference Pregabalin 75 mg and Etoricoxib 60mg dose will be administer orally One Tablet once a day with or without food for 08 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult male or female patients aged of 18-65 years
- •Patients willing to give written, signed, and dated informed consent to participate in the study.
- •Patients with chronic low back pain (symptoms duration: greater than or equal to 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
- •Patients who have pain score of at least 4 on the Numeric Pain Rating Scale (11-point).
排除标准
- •Patients with any contraindication, hypersensitivity or intolerance to either pregabalin or polmacoxib therapies or with history of hypersensitivity reactions to drugs of similar chemical classes or to any of its excipients.
- •History of Hepatitis B, Hepatitis C or HIV infection.
- •Use of any medications for ongoing chronic symptoms, or psychiatric disorders that could significantly diminish the cognitive ability or cause behavioral changes that would prevent the subject from complying with study procedures.
- •Patients on anticonvulsants, antidepressants (e.g., tricyclic, tetracyclic, atypical), aspirin at doses more than 81 mg/day, benzodiazepines, opioids, herbal medications, mexiletine HCl.
- •Patients with HbAlc greater than 8% at screening.
- •Patient received treatment with an investigational device or compound.
- •within 6 months prior of the screening.
- •Patients with known alcohol or other substance abuse within last one year as per DSM-5 criteria.
结局指标
主要结局
Change in Mean Numeric Pain Rating Scale (NPRS) levels
时间窗: Baseline to end of week 8
次要结局
- Percentage Change in Mean Numeric Pain Rating Scale (NPRS) levels(Baseline to end of week 4 and week 8)
- Change in Mean Numeric Pain Rating Scale (NPRS) levels(Baseline to week 4)
- Change in Mean Visual Analog Scale (VAS)(Baseline to week 4 and week 8)
- Change in Mean Roland-Morris Disability Questionnaire (RMDQ)(Baseline to week 4 and week 8)
- Consumption of rescue medication (total dose of paracetamol tablets consumed)(Baseline to week 4 and week 8)
- Patient Global Impression of Improvement (PGI-I)(At week 4 and week 8)
- Clinical Global Impression of Improvement (CGI-I)(At week 4 and week 8)
- Treatment emergent clinical & laboratory adverse events (TEAEs)(End of week 4 and week 8)
研究者
Dr Shubhadeep Sinha MD
Hetero Labs Limited