Health Condition 1: null- patients with mild to moderate pain.
Conditions
Interventions
Intervention1: Combination of Propoxyphene Napsylate and Acetaminophen: Combination of Propoxyphene Napsylate 100mg and Acetaminophen 400mg is to be thrice a day orally till pain completely disappears
Sponsors
Wockhardt Limited
Eligibility
Inclusion criteria
Inclusion criteria: • Patient of either sex aged between 18 to 65 years (inclusive) • Patients clinically diagnosed with mild to moderate pain (pain score greater than or equal to 7) not responding to Acetaminophen or NSAID monotherapy. • Patients having the willingness and ability to understand and provide informed consent to participate in the study and are able to communicate with the investigator and follow all directions. • Patients willing to undertake the contraceptive measures to prevent pregnancy during the study period.
Exclusion criteria
Exclusion criteria: • Patients with known hypersensitivity to Propoxyphene napsylate or Acetaminophen • Patients suffering from any disorder of kidney, liver or any unstable, clinically significant, or life-threatening medical disorders or any other underlying serious medical condition. • Patients with history of glaucoma, urinary retention, alcohol or drug abuse or SOAPP score > 7. (Refer section 10.0) • Patients currently taking tranquilizers or anti depressant drugs, sedatives, hypnotics or alcohol in excess. • Patients with h/o psychiatric / psychological disorders or suicidal ideation. • Patients with renal or hepatic failure. • Pregnant or lactating women. • Patients with any serious clinical conditions that according to the investigator may interfere with the evaluation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to evaluate the misuse potential of Proxyvon in management of mild to moderate pain. The objective is to demonstrate the safety and efficacy of Proxyvon in management of mild to moderate pain.Timepoint: Current Opioid Misuse Measure (COMM)score at end of 14 days Pain score (VAS) at the end of 5 days Percentage of pain relieved at the 5 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety OutcomesTimepoint: Adverse events 2. Percentage of pain relieved at the end of study treatment 3. Time required for complete pain relief 4. Duration of Therapy required 5. Review of study medication to offer pain relief by subject and investigator 6. Number of capsules required to relieve pain completely | — |
Countries
India
Contacts
Public ContactMs Seema Bawangade
Outcome results
None listed