title: Onset of action of diclofenac potassium liquid-filled capsules in dental surgery patients.
abstract: OBJECTIVE
  Diclofenac potassium soft gelatin capsules (DPSGC) are a low-dose, liquid-filled formulation that uses patented dispersion technology to facilitate rapid and consistent gastrointestinal absorption. Onset of pain relief experienced by patients receiving DPSGC was evaluated in two dental pain studies. Confirmed perceptible pain relief was evaluated in a post hoc analysis from these randomized controlled trials.
  
  
  METHODS
  Adult patients (n = 514) were enrolled in two multicenter, parallel group, double-blind, placebo-controlled studies. Patients undergoing third molar extraction and experiencing a requisite level of pain (≥50 mm on a 100-mm visual analog scale within 4 hours post-surgery) were randomized to receive single doses of DPSGC 25 mg, 50 mg, 100 mg, or placebo. Pain was assessed at baseline and during 6 hours after dosing. Times to onset of perceptible and meaningful pain relief were recorded using the two-stopwatch method. Confirmed perceptible pain relief was determined in the DPSGC and placebo groups by calculating the median time to onset of perceptible pain relief (first stopwatch) in only those individuals who reported meaningful pain relief (second stopwatch).
  
  
  RESULTS
  More than 80% of patients achieved confirmed perceptible pain relief in the DPSGC groups compared with less than 30% of patients in the placebo group (Study 1 and Study 2, p < 0.0001). The median time to onset of confirmed perceptible pain relief in the two studies was less than 30 minutes for patients receiving any dose of DPSGC and more than 360 minutes in the placebo group (Study 1 and Study 2, p < 0.0001). DPSGC was well tolerated and no serious adverse events were reported. Study design limitations include the short duration of the trial and evaluation of a relatively limited patient population.
  
  
  CONCLUSIONS
  These results indicate that DPSGC was efficacious in providing a rapid onset of confirmed perceptible pain relief within 30 minutes of administration in these single dose postoperative dental pain studies.
authors.affiliation: University of Texas Southwestern Medical Center, Dallas, TX 75390, USA. john.zuniga@UTsouthwestern.edu
authors.forename: John R
authors.initials: JR
authors.lastname: Zuniga
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Noveck
authors.forename: William K
authors.initials: WK
authors.lastname: Schmidt
authors.forename: Stephen E
authors.initials: SE
authors.lastname: Boesing
authors.forename: Elliot V
authors.initials: EV
authors.lastname: Hersh
mesh_terms: D000042:Absorption; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000465:Algorithms; D000700:Analgesics / Q000008:administration & dosage / Q000493:pharmacokinetics; D002214:Capsules; D003814:Dentistry, Operative / Q000379:methods; D004008:Diclofenac / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010149:Postoperative Pain / Q000188:drug therapy* / Q000378:metabolism; D010919:Placebos; D012996:Solutions / Q000008:administration & dosage / Q000493:pharmacokinetics; D013997:Time Factors; D055815:Young Adult
chemical_list: D000700:Analgesics; D002214:Capsules; D010919:Placebos; D012996:Solutions; D004008:Diclofenac