Tramadol/Diclofenac Fixed-dose Combination Phase III Trial in Acute Pain After Third Molar Extraction

Launched by GRÜNENTHAL GMBH · Oct 19, 2018

Keywords

ClinConnect Summary

The purpose of this study was to demonstrate that the FDC of Tramadol and Diclofenac 50/50 has superior analgesic effect than the monotherapies and that the FDC of Tramadol and Diclofenac 25/25 has non-inferior analgesic effect than the monotherapies. There was an Enrollment Period, a blinded Treatment Period, and a Follow-up Period. Previously used analgesic medication was washed out for at least 24 hours before surgery. The Treatment Period starts on Day 1 with dental surgery and treatment allocation. Treatment was started within 4 hours after the end of surgery if the participant's pain ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. The participant has read the informed consent form, has understood the relevant aspects of the clinical study, and grants his/her authorization to participate by signing the informed consent form prior to the inclusion in the clinical study and the performance of any procedure.
• • 2. Male and female participants above 18 years up to 60 years.
• • 3. Female participants of childbearing potential must be practicing an acceptable method of birth control and must have a negative urine pregnancy test at enrollment with confirmation at the Allocation Visit.
• • 4. Participants are in good health, i.e., the medical record, vital signs, physical examination, and laboratory parameter assessments do not show any abnormal deviations impeding the participation in the clinical study.
• • 5. Participants requiring extraction of 3 or more third molars with 2 mandibular impacted third molars.
• • 6. Clinical and radiological diagnosis of impacted lower third molars.
• • 7. Class I and Class II molars according to Pell and Gregory's classification (Gay Escoda et al. 2004).
• • 8. Participants must be able to swallow the IMPs.
• Exclusion Criteria at Enrollment:
• • 1. Findings in the medical record, vital signs, and/or physical examination demonstrating abnormal conditions of participant's general state of health preventing his/her participation in the clinical study according to the investigator's opinion.
• • 2. Participant unable to speak, read, or write in Spanish language.
• • 3. Clinical laboratory parameters exceed the pre-defined alert ranges (i.e., 1 standard deviation above or below the upper/lower limit of the normal ranges).
• • 4. Known hypersensitivity to the IMPs, the anesthetic to be used during surgery, or to the rescue medication (ibuprofen, ketorolac).
• • 5. Known alcohol or drug abuse in the last 6 months or any history of seizures. Alcohol abuse is defined as the consumption of more than 3 ounces (about 90 milliliters) of liquor or spirits or 18 ounces (about 530 milliliters) of beer per day, for 5 consecutive days during the 6-month period. Drug abuse is defined as the use of any recreational drug for 5 consecutive days during the 6 month period.
• • 6. Participants who take analgesic medication for chronic pain, monoamine oxidase inhibitors, tricyclic antidepressants, neuroleptics, or other drugs that reduce the seizure threshold within 4 weeks of enrollment.
• • 7. Pregnant or lactating women.
• • 8. Participants who received systemic corticosteroids or opioid analgesics less than 2 weeks before surgery.
• • 9. Participants with molars linked to the mandibular canal.
• • 10. Participants requiring immediate dental procedures other than third and fourth molars extraction,
• Exclusion Criteria at the Allocation Visit:
• • 11. Participant received a long-acting non-steroidal anti-inflammatory drug within 24 hours or 5 times the elimination half-life of that drug prior to surgery, whatever the longer.
• • 12. Participant received any analgesic medication other than short-acting pre-operative or intra-operative anesthetic agents within 24 hours before taking IMPs.
• • 13. Participant received more than 300 mg of lidocaine in total.
• • 14. Participant received any analgesic medication other than the IMPs immediately after the oral surgical procedure was completed.
• • 15. Baseline pain intensity of the participant after oral surgical procedure remains below 5 points on the 11-point NRS.