CTRI/2024/11/077285尚未招募4 期
A prospective, randomized, investigator initiated, assessor blinded, active controlled, single centre, phase IV clinical trial to compare the efficacy and safety of two different formulations of drotaverine in patients with spasmodic pain.
Dr. Chintan Patel1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年12月2日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Sum of Pain Intensity Difference over 6 hours (SPID-6) in the two arms using the VAS.
研究概览
简要总结
In this study, patients with established diagnosis of acute spasmodic pain including renal colic, gastrointestinal spasms, or acute primary dysmenorrhea requiring treatment with drotaverine will be screened and enrolled if found eligible. All the eligible patients will be followed up for at least 6 hours after the administration of the study medication for continuous monitoring. Initial evaluations will occur at Assessment 1 (Screening & Dosing) to establish baseline parameters. Subsequent assessments, Assessment 2 to 9, will be conducted at 15, 30, 45, and 60 minutes, then at 1.5, 2, 3, 4, and 5 hours post-dosing, with the final Assessment 10 (End of Study) concluding the study period. This will be a two-arm study and all the enrolled patients will be instructed to take the study medication as directed.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either gender between 18-65 years of age (both inclusive)
- •Patients with a confirmed clinical diagnosis of acute spasmodic pain (e.g., renal colic, gastrointestinal spasms, or acute primary dysmenorrhea)
- •Patients with baseline pain intensity rated as moderate to severe (≥40 mm) on the VAS
- •Patients willing to remain in the clinical setup for at least 6 hours after the administration of the study medication for continuous monitoring and follow-up.
- •Patients willing to provide written informed consent and comply with the protocol requirements.
排除标准
- •Patients who have received any of the following analgesics, opioids, or pain-relieving supplements (including topical, herbal, or other supplementary therapies) within the stipulated time frames: a.
- •Acetaminophen/Paracetamol (PCM): Within 8 hours before screening.
- •Drotaverine: Within 48 hours before screening.
- •Opioid Analgesics: Within 7 days before screening.
- •Aspirin: Within 5 half-lives or 5 days (whichever is longer) before screening.
- •Topical NSAIDs (e.g., Diclofenac gel): Within 48 hours before screening.
- •Other NSAIDs (e.g., ibuprofen, naproxen): Within 5 half-lives or 5 days before screening.
- •Local Anesthetics: (e.g., lidocaine patches, topical lidocaine creams) within 48 hours before screening.
- •Herbal or Supplementary Pain-Relief: i.
- •Herbal remedies (e.g., turmeric, ginger, willow bark) taken orally or topically within 7 days before screening.
- •Topical pain-relief products (e.g., capsaicin, menthol-based creams) applied within 7 days before screening.
- •Other Medications: i.
- •Muscle relaxants (e.g., baclofen, cyclobenzaprine): Within 72 hours before screening.
- •Corticosteroids (e.g., oral or injected corticosteroids): Within 14 days before screening.
- •Patients with known hypersensitivity or allergy to drotaverine or any component of the study drug.
- •Patients with a known history of significant hepatic, renal, or cardiovascular conditions, uncontrolled diabetes, or other major medical conditions that could interfere with the study.
- •Patients with non-spasmodic chronic pain, such as neuropathic pain.
- •Patients with a history of drug or alcohol abuse that may interfere with the interpretation of study results.
- •Pregnant or lactating females.
- •Patients unwilling to comply with study requirements.
- •Any other reason for which the investigator feels that the patient should not participate.
结局指标
主要结局
Sum of Pain Intensity Difference over 6 hours (SPID-6) in the two arms using the VAS.
时间窗: from baseline(0 hour) to 6 hours
次要结局
- Mean Pain Intensity Difference (mPID) measured in the two arms using the VAS.(at 15, 30, 45, 60 minutes, and at 1.5, 2, 3, 4, 5, and 6 hours post-dose from baseline(0 hour))
- Percentage of patients achieving ≥50% pain relief or Total Pain Relief (TOTPAR) in the two arms based on VAS.(at 6 hours post-dose from baseline(0 hour))
- Percentage of patients perceived onset of pain relief in the(two arms.)
- Proportion of patients withdrawn and given rescue medication in lack of response to the treatment.(during 6 hours post-dose)
- Number of Adverse events reported into the study(Baseline to end of study)
- Number of Serious Adverse events reported into the study(Baseline to end of study)
研究者
Dr Jayesh Sanmukhani
Clinexcel Research
研究点 (1)
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