PMID- 24300220
OWN - NLM
STAT- MEDLINE
DCOM- 20150512
LR  - 20140906
IS  - 1536-5409 (Electronic)
IS  - 0749-8047 (Linking)
VI  - 30
IP  - 10
DP  - 2014 Oct
TI  - A phase 2 study of lower-dose, indomethacin submicron particle capsules 
      demonstrates early onset of acute pain relief.
PG  - 846-51
LID - 10.1097/AJP.0000000000000053 [doi]
AB  - OBJECTIVES: Nonsteroidal anti-inflammatory drugs are efficacious for the 
      treatment of acute and chronic pain; however, they have the potential for serious 
      adverse events (AEs). The objective of this study was to evaluate the efficacy 
      and safety of investigational, lower-dose, indomethacin submicron particle 
      capsules compared with placebo in a study of patients with postsurgical pain. 
      MATERIALS AND METHODS: This phase 2, multicenter, randomized, double-blind, 
      single-dose, and placebo-controlled study enrolled 203 patients (18 to 50 y old) 
      following extraction of >/= 2 third molars who experienced moderate-to-severe pain 
      intensity </= 6 hours after surgery. Patients received indomethacin submicron 
      particle capsules (20 or 40 mg), celecoxib 400 mg, or placebo. The primary 
      efficacy endpoint was the sum of total pain relief over 0 to 8 hours (TOTPAR-8) 
      determined from the area under the curve for pain relief over 0 to 8 hours 
      following administration of the study drug, where pain relief was measured on a 0 
      to 4 scale. Safety and tolerability were also assessed. RESULTS: Mean +/- SE 
      TOTPAR-8 scores were 10.8 +/- 1.4 (indomethacin submicron particle capsules 20 mg), 
      12.6 +/- 1.3 (indomethacin submicron particle capsules 40 mg), 14.8 +/- 1.3 
      (celecoxib), and 3.0 +/- 1.3 (placebo; P<0.001 for active treatments vs. placebo). 
      Indomethacin submicron particle capsules treatment groups demonstrated better 
      mean TOTPAR over 4 hours than placebo (P<0.001). Similar rates and profiles of 
      treatment-emergent AEs were reported by patients across treatment groups. 
      DISCUSSION: Lower-dose, indomethacin submicron particle capsules provide good 
      overall pain relief in patients with postsurgical pain and are generally well 
      tolerated. Indomethacin submicron particle capsules are a potentially promising 
      option for treatment of acute pain and warrant further study.
FAU - Manvelian, Garen
AU  - Manvelian G
AD  - *MIG Clinical Research Consulting, San Diego daggerDivision of Rheumatology & Clinical 
      Immunology, University of Maryland School of Medicine, Baltimore, MD double daggerPremier 
      Research Group International, LLC, Austin, TX  section signUCLA Medical Center RHU, Los 
      Angeles, CA  parallelIroko Pharmaceuticals LLC, Philadelphia, PA.
FAU - Hochberg, Marc C
AU  - Hochberg MC
FAU - Daniels, Stephen E
AU  - Daniels SE
FAU - Altman, Roy D
AU  - Altman RD
FAU - Young, Clarence L
AU  - Young CL
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Clin J Pain
JT  - The Clinical journal of pain
JID - 8507389
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 0 (Capsules)
RN  - XXE1CET956 (Indomethacin)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Anti-Inflammatory Agents, Non-Steroidal/*therapeutic use
MH  - Capsules/administration & dosage
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Indomethacin/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Pain Measurement
MH  - Pain, Postoperative/*drug therapy
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2013/12/05 06:00
MHDA- 2015/05/13 06:00
CRDT- 2013/12/05 06:00
PHST- 2013/12/05 06:00 [entrez]
PHST- 2013/12/05 06:00 [pubmed]
PHST- 2015/05/13 06:00 [medline]
AID - 10.1097/AJP.0000000000000053 [doi]
PST - ppublish
SO  - Clin J Pain. 2014 Oct;30(10):846-51. doi: 10.1097/AJP.0000000000000053.