A clinical trial to study the effect of Tapentadol HCl compared to Tramadol in post operative dental patients.

Phase 3

Completed

Registration Number: CTRI/2010/091/001028

Lead Sponsor: Macleods Pharmaceuticals LtdG-2, Mahakali Caves Road, Shanti Nagar,Andheri-East, Mumbai-400059

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

1.Patient of either sex with an age of 18 - 75 years
2.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 molars
4.At least moderate pain within 5 hours after oral surgery procedure
5.Sufficiently alert to follow directions, communicate with study personnel and perform study procedures
6.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 epilepsy
2.Previously treated patients who have discontinued treatment due to an adverse event
3.History of malignancy within the past 2 years before starting the study
4.History of alcohol or drug abuse
5.Evidence of active infections that may spread to other areas of the body
6.Clinical laboratory values reflecting severe renal insufficiency
7.Moderately or severely impaired hepatic function
8.Patients with an uncontrolled medical condition
9.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 surgery
10.Currently treated with anticonvulsants, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), neuroleptics, or serotonin norepinephrine reuptake inhibitor (SNRI)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Global Clinical assessment for functional signs of post-operative dental pain:<br>-Peak Pain relief (PPR)<br>-Peak Pain intensity difference (PPID)<br>-Total Pain relief over 8 hrs (TOTPAR-8)<br>-Total Pain relief over 4 hrs (TOTPAR-4)<br>-Sum of Pain intensity difference at 8 hrs (SPID-8)<br>-Sum of Pain intensity difference at 4 hrs (SPID-4)<br>-Percentage of patients experiencing 50% pain relief<br>Timepoint: Visit 1: Day 01 Admission to the study<br>Visit 2: Day 02 During therapy visit<br>Visit 3: Day 03 End of therapy visit<br>

Secondary Outcome Measures

Name	Time	Method
Efficacy will be graded as follows: <br>a] Cured: Significant Improvement in the severity of symptoms and parameters of evaluation of Post-operative dental pain.<br>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.<br>Timepoint: At end of treatment