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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001028

Enrollment

200

Registered

2010-07-19

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Tapentadol HCl-IR Tablet 100mg: Dose: One tablet every 4-6 hrs in a day Duration-3 days Control Intervention1: Tramadol HCl Tablet 100mg: Dose: One tablet every 4-6 hrs in a day. Durati

Eligibility

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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 Timepoint: Visit 1: Day 01 Admission to the study Visit 2: Day 02 During therapy visit Visit 3: Day 03 End of therapy visit	—

Measure

Time frame

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 Timepoint: Visit 1: Day 01 Admission to the study Visit 2: Day 02 During therapy visit Visit 3: Day 03 End of therapy visit

—

Secondary

Measure	Time frame
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. Timepoint: At end of treatment	—

Countries

India

Contacts

Public ContactMr.Amol Choulwar

achoulwar@macleodspharma.com02228306435

Outcome results