None listed
Conditions
Interventions
Intervention1: Tapentadol: 50mg
Control Intervention1: Tramadol: 50mg
Sponsors
M/s. MSN Laboratories Ltd., Hyderabad
Eligibility
Inclusion criteria
Inclusion criteria: &#9632; All patients with duly filled and signed in ICFs [Informed Consent Forms] &#9632; Ages: > 18 years and < 80 years &#9632; Genders Eligible for Study: both &#9632; Patients who are candidates for orthopedic surgery. &#9632; Patients requiring daily doses of analgesics, consistent with treatment at step II or higher of the World Health Organization pain relief ladder. &#9632; In addition, eligible patients has to report a mean pain intensity score > 5 on an II-point numerical rating scale (NRS) over 3 days of pain measurements completed before randomized assignment to treatment groups. &#9632; Women of childbearing age using accepted mode of birth control.
Exclusion criteria
Exclusion criteria: &#9632; The exclusion criteria are based on precautions related to centrally acting analgesics and the standard conduct of clinical trials. &#9632; Patients unwilling to sign on ICF &#9632; Patients with a history of chronic hepatitis B or C infection, HIV infection, &#9632; Patients with presence or history of malignancy (within the last 2 years), or alcohol or drug abuse. &#9632; Patients with suspected or apparent seizure disorders, concomitant autoimmune inflammatory conditions involving the target joint, acute crystal-induced arthropathy (within 6 months before screening), moderate to severe renal insufficiency, or hepatic impairment. &#9632; Patients will also be excluded if they have received systemic steroid therapy within 4 weeks before screening, IR opioids for >4 days per week within 28 days of the screening period, or extended-release opioids within 28 days of the screening period. &#9632; Patients who have received an experimental drug or used an experimental device within 28 days of study entry will be excluded from participation, as will be patients with a history of sensitivity to Tapentadol, hydromorphone, morphine, fentanyl, or their excipients. &#9632; Patients who had previously participated in studies of Tapentadol will also be excluded. &#9632; Pregnant or lactating patients &#9632; Patients having abnormal liver parameters such high values of AST, ALT and ALP, &#9632; Patients having received other investigational medication within the last 3 months, or having participated in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy outcome for this study is the evaluation of pain done on twice daily basis by the patient himself using 11-point NRS scale, where 0 is no pain and 10 is worst possible pain experienced. The investigator will perform this test on day 0 i.e. day of randomization, day 5 i.e. day of interim analysis and day 10, which is the end of the study period. 2] Pain intensity difference (PID) This will be used to examine the change in pain intensity from baseline and will be calculated as baseline pain intensity - current pain intensity, with the mean pain intensity from the 3 days of pain intensity measurements before randomization used as the baseline value. Sum of PID over the first 5 days (5-day SPID), the primary efficacy end point, will be calculated as &#931;PID (time elapsed since the previous observation), with the sum including all observations of PID collected from the evening of day 1 to the evening of day 5. Two-day SPID and 10-day SPID will be calculated in a similar manner. Timepoint: 10 day;The primary efficacy outcome for this study is the evaluation of pain done on twice daily basis by the patient himself using 11-point NRS scale, where 0 is no pain and 10 is worst possible pain experienced. The investigator will perform this test on day 0 i.e. day of randomization, day 5 i.e. day of interim analysis and day 10, which is the end of the study period. 2] Pain intensity difference (PID) This will be used to examine the change in pain intensity from baseline and will be calculated as baseline pain intensity - current pain intensity, with the mean pain intensity from the 3 days of pain intensity measurements before randomization used as the baseline value. Sum of PID over the first 5 days (5-day SPID), the primary efficacy end point, will be calculated as &#931;PID (time elapsed since the previous observation), with the sum including all observations of PID collected from the evening of day 1 to the evening of day 5. Two-day SPID and | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include the effect of Tapentadol IR on the basis of Patient Global Impression of Change (PGIC) at the baseline, day 5 and day 10, which is the end point of the trial. PGIC will be assessed, wherein patients will indicate their response to the statement "Since I began study medication, my overall status is ..." using a scale from 1 =very much improved to 7 =very much worse.Timepoint: 10 day;Secondary outcomes include the effect of Tapentadol IR on the basis of Patient Global Impression of Change (PGIC) at the baseline, day 5 and day 10, which is the end point of the trial. PGIC will be assessed, wherein patients will indicate their response to the statement "Since I began study medication, my overall status is ..." using a scale from 1 =very much improved to 7 =very much worse.Timepoint: 10 day | — |
Countries
India
Contacts
Public ContactDr.Vinayak Samant
Outcome results
None listed