Health Condition 1: R52- Pain, unspecified
Conditions
Interventions
Intervention1: New formulation of Drotaverine 40mg: single oral dose of 40mg tablets (once only
single dose study)
Control Intervention1: Conventional formulation of Drotaverine 40mg: single oral dose of 40mg tablets (once only
single dose study)
Sponsors
Dr. Chintan Patel
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either gender between 18-65 years of age (both inclusive) 2. Patients with a confirmed clinical diagnosis of acute spasmodic pain (e.g., renal colic, gastrointestinal spasms, or acute primary dysmenorrhea) 3. Patients with baseline pain intensity rated as moderate to severe (=40 mm) on the VAS 4. 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. 5. Patients willing to provide written informed consent and comply with the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. 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. b. Drotaverine: Within 48 hours before screening. c. Opioid Analgesics: Within 7 days before screening. d. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): i. Aspirin: Within 5 half-lives or 5 days (whichever is longer) before screening. ii. Topical NSAIDs (e.g., Diclofenac gel): Within 48 hours before screening. iii. Other NSAIDs (e.g., ibuprofen, naproxen): Within 5 half-lives or 5 days before screening. e. Local Anesthetics: (e.g., lidocaine patches, topical lidocaine creams) within 48 hours before screening. f. Herbal or Supplementary Pain-Relief: i. Herbal remedies (e.g., turmeric, ginger, willow bark) taken orally or topically within 7 days before screening. ii. Topical pain-relief products (e.g., capsaicin, menthol-based creams) applied within 7 days before screening. g. Other Medications: i. Muscle relaxants (e.g., baclofen, cyclobenzaprine): Within 72 hours before screening. ii. Corticosteroids (e.g., oral or injected corticosteroids): Within 14 days before screening. 2. Patients with known hypersensitivity or allergy to drotaverine or any component of the study drug. 3. 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. 4. Patients with non-spasmodic chronic pain, such as neuropathic pain. 5. Patients with a history of drug or alcohol abuse that may interfere with the interpretation of study results. 6. Pregnant or lactating females. 7. Patients unwilling to comply with study requirements. 8. Any other reason for which the investigator feels that the patient should not participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sum of Pain Intensity Difference over 6 hours (SPID-6) in the two arms using the VAS.Timepoint: from baseline(0 hour) to 6 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of Adverse events reported into the studyTimepoint: Baseline to end of study;Number of Serious Adverse events reported into the studyTimepoint: Baseline to end of study;Mean Pain Intensity Difference (mPID) measured in the two arms using the VAS.Timepoint: 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.Timepoint: at 6 hours post-dose from baseline(0 hour);Percentage of patients perceived onset of pain relief in the two arms.Timepoint: at less than 15 minutes, between 16-30 minutes, 31 to 60 minutes, more than 60 minutes post-dose from baseline(0 hour);Proportion of patients withdrawn and given rescue medication in lack of response to the treatment.Timepoint: during 6 hours post-dose | — |
Countries
India
Contacts
Public ContactDr Jayesh Sanmukhani
Clinexcel Research
Outcome results
None listed