Health Condition 1: M00-M99- Diseases of the musculoskeletal system and connective tissue
Conditions
Interventions
Intervention1: Nefopam hydrochloride: The test product is Nefopam hydrochloride 30 mg. Patient will take 1 tablet of Nefopam hydrochloride30 mg thrice daily for 5 days. The tablets must be swallowed o
Sponsors
Department of PharmacologyPGIMERChandigarh
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients above 18 years up to 60 years 2. Both male and female (of childbearing potential) patients willing to use appropriate method of contraception as per investigatorâ??s discretion throughout the study. Female of childbearing potential must have a negative pregnancy test and be non-lactating at baseline 3. The patient has read the ICF, has understood the relevant aspects of the clinical study, and grants his/her authorization to participate by signing the ICF before the inclusion in the clinical study and the performance of any procedure 4. Moderate or severe pain (score of at least 50 mm on 100 mm VAS within 4 hours post-surgery or at the time of visit to the investigator) at baseline undergoing dental procedures requiring either of the two study medications or patients with back pain, neck pain or degenerative pain. 5. Patients with acute/acute-on-chronic pain, including post-operative, joint, or acute traumatic pain. 6. Patient is in good health, i.e., the medical record, vital signs, physical examination, and laboratory parameter assessments do not show any abnormal deviations impeding the participation in the clinical study at screening and baseline visit 7. Patient must be able to swallow the study drug 8. Patientwilling to fill patient diaries and comply with the study procedure and requirements. A patient/caregiver who is able to read, understand, and willing to sign and date written ICF 9. Patient who has shown suboptimal response to NSAIDs and other systemic therapies.
Exclusion criteria
Exclusion criteria: Patient received any analgesic medication other than short-acting pre-operative or intra-operative anesthetic agents within 12 hours before taking the study drug Received a long-acting NSAIDs within 3 days prior to dosing History of any significant medical condition (e.g., significant psychiatric disorders [suicidal tendencies, emotional disturbance, depression etc] or neurological disorders[convulsive disorders, epilepsy, seizures],anaphylactoid reactions to codeine and other opioids, asthma, severe liver, hepatic, and renal dysfunction, peptic ulcer disease, acute abdominal conditions, ischemic heart disease, seizures, glaucoma, etc.), or any medical condition that is unstable/poorly controlled or other factor (e.g., planned relocation) that the investigator felt would interfere with study evaluations and study participation BMI >= 35 kg/m2 Participation in any other clinical study in past 30 days Patientwho isonmonoamine oxidase inhibitors, tricyclic antidepressants, neuroleptics, or other drugs that reduce the seizure threshold within 4 weeks of enrollment Patient with central nervous system, respiratory depression, increased intracranial pressure or head injury and more in detailed protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in pain intensity from baseline to 3 hours and 6 hours post-dose on 100 mm VAS ranging from â??score 0 (no pain)â?? to â??score 100 (worst pain imaginable)â??between Test and Reference groupsTimepoint: Change in pain intensity from baseline to 3 hours and 6 hours post-dose on 100 mm VAS ranging from â??score 0 (no pain)â?? to â??score 100 (worst pain imaginable)â??between Test and Reference groups | — |
Secondary
| Measure | Time frame |
|---|---|
| Average dose of Paracetamol taken by patients from baseline (prior to dosing) to Day 5 between Test and Reference groupsTimepoint: Average dose of Paracetamol taken by patients from baseline (prior to dosing) to Day 5 between Test and Reference groups;Change in physical examination from baseline (prior to dosing) to Day 5Timepoint: Change in physical examination from baseline (prior to dosing) to Day 5;Change in SPID from baseline (prior to dosing) to 3 and 6hourspost-dose on Day 1within and between Test and Reference groups on 100 mm VAS(ranging from â??score 0 [no pain]â?? to â??score 100 [worst pain imaginable]â??)Timepoint: Change in SPID from baseline (prior to dosing) to 3 and 6hourspost-dose on Day 1within and between Test and Reference groups on 100 mm VAS(ranging from â??score 0 [no pain]â?? to â??score 100 [worst pain imaginable]â??);Change in vital signs (pulse rate, SBP and DBP, respiratory rate, and body temperature after 5 minutes of rest in supine position) from baseline (prior to dosing) to Day 5Timepoint: Change in vital signs (pulse rate, SBP and DBP, respiratory rate, and body temperature after 5 minutes of rest in supine position) from baseline (prior to dosing) to Day 5;Global tolerability assessment by patients and investigators onDay 5 graded on a 3-point scale ranging from â??score 0 (good tolerability [side effects may be mild or not observed])â?? to â??score 2 (poor tolerability [side effects severe or discontinuation])â??Timepoint: Global tolerability assessment by patients and investigators onDay 5 graded on a 3-point scale ranging from â??score 0 (good tolerability [side effects may be mild or not observed])â?? to â??score 2 (poor tolerability [side effects severe or discontinuation])â??;Number and proportion of patients with AEs/SAEsTimepoint: Number and proportion of patients with AEs/SAEs;Percentage of mean change in VAS score from baseline (prior to dosing) to Day 3 and Day 5 within and between Test and Reference groups on 100 mm VAS | — |
Countries
India
Contacts
Public ContactSamir Malhotra
PGIMER Chandigarh
Outcome results
None listed