A MULTICENTRIC, OPEN-LABEL, ANALYST-BLIND, RANDOMIZED, PARALLEL-GROUP, TRAMADOL-CONTROLLED, PHASE-III CLINICAL TRIAL TO ASSESS THE EFFICACY, TOLERABILITY, AND SAFETY OF TAPENTADOL TABLETS IN PATIENTS OF OSTEOARTHRITIS & POST-OPERATIVE PAIN AFTER ORTHOPEDIC SURGERY?

M/s. MSN Laboratories Ltd., Hyderabad4 sites in 1 country200 target enrollmentStarted: TBD

Overview

Phase: Phase 3
Sponsor: M/s. MSN Laboratories Ltd., Hyderabad
Enrollment: 200
Locations: 4
Primary Endpoint: 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 ΣPID (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.

Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Overview

Brief Summary

This study is a randomized, open label, parallel group, multi centre trail comparing the safety and efficacy of Tapentadol in patients with Osteoarthritis & Post-Operative Pain after Orthopedic Surgery for 5 months in 200 patients will be conducted in four centres in India

Study Design

Allocation: Computer generated randomization
Masking: Open Label

Eligibility Criteria

Inclusion Criteria

•■All patients with duly filled and signed in ICFs [Informed Consent Forms] ■Ages: > 18 years and < 80 years ■Genders Eligible for Study: both ■Patients who are candidates for orthopedic surgery.
•■Patients requiring daily doses of analgesics, consistent with treatment at step II or higher of the World Health Organization pain relief ladder.
•■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.■Women of childbearing age using accepted mode of birth control.

Exclusion Criteria

•■The exclusion criteria are based on precautions related to centrally acting analgesics and the standard conduct of clinical trials.
•■Patients unwilling to sign on ICF■Patients with a history of chronic hepatitis B or C infection, HIV infection, ■Patients with presence or history of malignancy (within the last 2 years), or alcohol or drug abuse.
•■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.
•■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.
•■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.
•■Patients who had previously participated in studies of Tapentadol will also be excluded.■Pregnant or lactating patients■Patients having abnormal liver parameters such high values of AST, ALT and ALP, ■Patients having received other investigational medication within the last 3 months, or having participated in the trial.

Outcomes

Primary Outcomes

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 ΣPID (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.

Time Frame: 10 day

Secondary Outcomes

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.(10 day)

Investigators

Sponsor

M/s. MSN Laboratories Ltd., Hyderabad

Study Sites (4)

Loading locations...

Similar Trials

Unknown

Phase 3

A clinical trial to study the effects of two drugs, fexofenadine and montelukast in the treatment of persistent allergic rhinitis

CTRI/2010/091/000517M/S. Theon Pharmaceuticals Ltd.200

Completed

Phase 3

A clinical trial to study effectiveness and safety of Fixed dose combination tablets of Hyoscine butylbromide & Mefenamic acid in patients suffering from paroxysmal spastic abdominal pain

CTRI/2011/091/000141Cadila Healthcare Ltd200

Completed

Phase 4

A Study to Compare the Efficacy, Safety and Tolerability of Selomax With Its Individual ComponentsPrimary Hypertension

NCT00819104AstraZeneca402

Completed

Phase 3

Safety and Tolerability of Glatiramer AcetateRelapsing-Remitting Multiple Sclerosis

NCT01874145Teva Branded Pharmaceutical Products R&D, Inc.209

Recruiting

Phase 4

A Study to evaluate the Safety and Efficacy of FDC of Trypsin 48 mg plus Bromelain 90 mg plus Rutoside Trihydrate 100 mg plus Diclofenac Sodium 50 mg enteric coated tablet versus Diclofenac Sodium 50 mg enteric coated tablet in patients with surgical wounds after minor surgery.

CTRI/2017/11/010384Macleods Pharmaceuticals Ltd383