An Open, Comparative, Randomized, Prospective, Multi Centric Clinical Trial To Compare The Efficacy And Safety Of Tapentadol HCl-IR Versus Tramadol HCl In Case of Post-operative Dental Patients
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 200
- Locations
- 5
- Primary Endpoint
- Global Clinical assessment for functional signs of post-operative dental pain:-Peak Pain relief (PPR)-Peak Pain intensity difference (PPID)-Total Pain relief over 8 hrs (TOTPAR-8)-Total Pain relief over 4 hrs (TOTPAR-4)-Sum of Pain intensity difference at 8 hrs (SPID-8)-Sum of Pain intensity difference at 4 hrs (SPID-4)-Percentage of patients experiencing 50% pain relief
Study Overview
Brief Summary
Tapentadol is an opioid analgesic indicated for the relief of moderate to severe acute pain in patients 18 years of age or older. Tapentadol is a centrally-acting synthetic analgesic that activates opioid receptors in the brain, spinal cord and gastrointestinal tract, and also inhibits reuptake of norepinephrine. It is a open, Comparative, Randomized and Prospective, Phase-III, Multicentric Clinical Trial caomparing the efficacy and safety of Tapentadol 100mg and Tramadol 100mg for 3 days in 200 patients of post operative dental pain.Study Duration:3 DaysPrimary diagnosis:Patients suffering from moderate to severe dental pain associated with Post-operative surgery, Molar surgery.For this study a total of 200 patients will be enrolled from different centers. These 200 patients will be randomized for Group-A (i.e. Tapentadol HCl-IR) or Group-B (i.e. Tramadol HCl), 100 patients in each group.All these patients will be recruited from different centres.Efficacy will be evaluated based on the acute dental pain as highly standardized and sensitive for therapeutic efficacy of treatment medicine and the efficacy measures used are considered valid, reliable, sensitive and specific method to assess post-operative dental pain.Depending on inclusion and exclusion criteria patient will be enrolled for the study.After recording the history of patients disease condition and treatment received patient will undergo laboratory investigations for assessment of baseline safety and efficacy parameters. Patient will also undergo a physical examination. Patient will either receive Tapentadol HCl-IR tablet 100mg one tablet every 4-6 hrs in a day or Tramadol HCl tablet 100mg one tablet every 4-6 hrs in a day depending on group assigned, for a period of 3 days.patient will be required to come for follow up on Day-1, Day-2 & at the end of therapy i.e. on Day-3. patient will be subjected to physical and clinical examination during all these follow up visits. While patient will undergo for second round of laboratory investigation at the end of treatment. Adverse events experienced by patients, if any, will be recorded during these visits.Efficacy will be graded as follows: a] Cured: Significant Improvement in the severity of symptoms and parameters of evaluation of Post-operative dental pain.b] Failure: Either no improvement or worsening of severity of symptoms and parameters of evaluation of Post-operative dental pain at the end of therapy.
Study Design
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
Inclusion Criteria
- •1.Patient of either sex with an age of
- •75 years2.Patients ready to give informed consent to participate in the trial 3.Surgical procedure involving removal of >= 2 impacted third molars with bone removal required for at least 2 of the 3 impacted third molars4.At least moderate pain within 5 hours after oral surgery procedure5.Sufficiently alert to follow directions, communicate with study personnel and perform study procedures6.If female, using an acceptable method of birth control and has a negative urine pregnancy test.
Exclusion Criteria
- •1.Patients will be excluded from the study if they have a history of seizure disorder or epilepsy2.Previously treated patients who have discontinued treatment due to an adverse event3.History of malignancy within the past 2 years before starting the study4.History of alcohol or drug abuse5.Evidence of active infections that may spread to other areas of the body6.Clinical laboratory values reflecting severe renal insufficiency7.Moderately or severely impaired hepatic function8.Patients with an uncontrolled medical condition9.Patients who have used pain medication (other than anesthesia) within 24 hours of receiving study medication, any long-acting over-the-counter pain medications within 3 days, or any pain medication after finishing oral surgery10.Currently treated with anticonvulsants, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), neuroleptics, or serotonin norepinephrine reuptake inhibitor (SNRI).
Outcomes
Primary Outcomes
Global Clinical assessment for functional signs of post-operative dental pain:-Peak Pain relief (PPR)-Peak Pain intensity difference (PPID)-Total Pain relief over 8 hrs (TOTPAR-8)-Total Pain relief over 4 hrs (TOTPAR-4)-Sum of Pain intensity difference at 8 hrs (SPID-8)-Sum of Pain intensity difference at 4 hrs (SPID-4)-Percentage of patients experiencing 50% pain relief
Time Frame: Visit 1: Day 01 Admission to the studyVisit 2: Day 02 During therapy visitVisit 3: Day 03 End of therapy visit
Secondary Outcomes
- Efficacy will be graded as follows: a] Cured: Significant Improvement in the severity of symptoms and parameters of evaluation of Post-operative dental pain.b] Failure: Either no improvement or worsening of severity of symptoms and parameters of evaluation of Post-operative dental pain at the end of therapy.(At end of treatment)