Tramadol/Diclofenac Fixed-dose Combination Phase III Trial in Acute Pain After Third Molar Extraction
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluated a new drug fixed-dose combination tablet (FDC) called
      tramadol/diclofenac at two different strengths (fixed doses of 25 milligrams [mg] of tramadol
      and of diclofenac or of 50 mg each). Tramadol and diclofenac each relieve pain, but they do
      so by different mechanisms. They were used alone as comparator drug in this study. Both are
      marketed drugs and are standard treatment for acute pain, including wisdom tooth removal.
    

Detailed description: 
      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 intensity had reached at
      least 5 points on the 11-point numerical rating scale (NRS). Each participant received 3
      doses of one of the four treatments within 24 hours. One fourth of the participants received
      the fixed-dose combination tablet at a low dose, one fourth at the higher dose, one fourth
      received 50 mg of the comparator tramadol alone, and one fourth 50 mg of the comparator
      diclofenac alone.

      The first 2 doses of the investigational medicinal product (IMP) were taken at the site, the
      last dose in an out-patient setting. Participants returned to the site at 24 hours after the
      first dose. A Follow-up Period included a final visit at the site or a phone call on Day 14
      to assess the participant's safety.
    

Intervention name(s): Tramadol/Diclofenac 50/50; Tramadol/Diclofenac 25/25; Tramadol 50; Diclofenac 50
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Each dose comprised 1 fixed-dose combination tablet and 3 placebo tablets or capsules matching the other active treatment groups. Doses were taken 8 hours apart.; Each dose comprised 1 fixed-dose combination tablet and 3 placebo tablets or capsules matching the other active treatment groups. Doses were taken 8 hours apart.; Each dose comprised 1 capsule containing 50 mg tramadol hydrochloride and 3 placebo tablets matching the other active treatment groups. Doses were taken 8 hours apart.; Each dose comprised 1 tablet containing 50 mg diclofenac sodium and 3 placebo tablets or capsules matching the other active treatment groups. Doses were taken 8 hours apart.
Other intervention name(s): Adorlan Forte (Registered Trademark); Adorlan (Registered Trademark); Tramadol immediate-release capsule; Tradol (Registered Trademark); Voltaren (Registered Trademark) (diclofenac enteric-coated tablet)
Intervention MeSH terms: Diclofenac; Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Wisdom tooth removal; Dental pain