PMID- 23043637
OWN - NLM
STAT- MEDLINE
DCOM- 20130503
LR  - 20151119
IS  - 1526-4637 (Electronic)
IS  - 1526-2375 (Linking)
VI  - 13
IP  - 11
DP  - 2012 Nov
TI  - A phase 2 study evaluating the efficacy and safety of a novel, proprietary, 
      nano-formulated, lower dose oral diclofenac.
PG  - 1491-8
LID - 10.1111/j.1526-4637.2012.01479.x [doi]
AB  - BACKGROUND:  Safety concerns associated with nonsteroidal anti-inflammatory drugs 
      (NSAIDs) have prompted the development of new formulations that minimize adverse 
      events (AEs) and maintain efficacy. OBJECTIVES: To determine the analgesic 
      efficacy and safety of an investigational, proprietary, nano-formulated, oral 
      diclofenac (nano-formulated diclofenac) compared with placebo in subjects with 
      acute dental pain. METHODS:  A Phase 2, multisite, randomized, double-blind, 
      single-dose, parallel-group, active- and placebo-controlled study was carried out 
      in 202 subjects (18-50 years old) who had extraction of >/=2 third molars (>/=1 had 
      to be a fully or partially impacted mandibular third molar) and experienced 
      moderate to severe pain intensity </=6 hours postsurgery (NCT00985439). Subjects 
      received nano-formulated diclofenac 35 mg or 18 mg, celecoxib 400 mg, or placebo. 
      The primary efficacy variable was the sum of total pain relief (TOTPAR) over 0-12 
      hours (TOTPAR-12) after Time 0. Secondary end points included TOTPAR over 0-4 
      hours (TOTPAR-4), TOTPAR over 0-8 hours (TOTPAR-8), and time to onset of 
      analgesia. RESULTS: Mean +/- standard deviation TOTPAR-12 for nano-formulated 
      diclofenac 35 mg and 18 mg, celecoxib, and placebo were 16.81 +/- 12.76, 
      17.76 +/- 13.76, 14.61 +/- 15.05, and 5.65 +/- 11.53, respectively (P < 0.001, 
      nano-formulated diclofenac compared with placebo). Similar improvements were 
      observed for TOTPAR-4, TOTPAR-8, mean time to first perceptible pain relief 
      (P < 0.001), and peak relief (P < 0.05). Celecoxib treatment was not 
      statistically different than placebo for these latter two parameters. 
      Treatment-emergent AEs were similar across all treatment groups. CONCLUSIONS: 
      Lower dose, nano-formulated diclofenac demonstrated good overall efficacy, prompt 
      pain relief, and was well tolerated. These data suggest lower dose 
      nano-formulated NSAIDs could be effective for acute pain and may potentially 
      improve safety and tolerability as a result of using a lower overall dose.
CI  - Wiley Periodicals, Inc.
FAU - Manvelian, Garen
AU  - Manvelian G
AD  - Iroko Pharmaceuticals, LLC, Navy Yard Corporate Center, Philadelphia, USA.
FAU - Daniels, Stephen
AU  - Daniels S
FAU - Gibofsky, Allan
AU  - Gibofsky A
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20121008
PL  - England
TA  - Pain Med
JT  - Pain medicine (Malden, Mass.)
JID - 100894201
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 0 (Pyrazoles)
RN  - 0 (Sulfonamides)
RN  - 144O8QL0L1 (Diclofenac)
RN  - JCX84Q7J1L (Celecoxib)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Anti-Inflammatory Agents, Non-Steroidal/*administration & dosage
MH  - Celecoxib
MH  - Diclofenac/*administration & dosage
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Molar, Third/surgery
MH  - Nanotechnology
MH  - Pain, Postoperative/*drug therapy/etiology
MH  - Pyrazoles/therapeutic use
MH  - Sulfonamides/therapeutic use
MH  - Tooth Extraction/adverse effects
MH  - Young Adult
EDAT- 2012/10/10 06:00
MHDA- 2013/05/04 06:00
CRDT- 2012/10/10 06:00
PHST- 2012/10/10 06:00 [entrez]
PHST- 2012/10/10 06:00 [pubmed]
PHST- 2013/05/04 06:00 [medline]
AID - 10.1111/j.1526-4637.2012.01479.x [doi]
PST - ppublish
SO  - Pain Med. 2012 Nov;13(11):1491-8. doi: 10.1111/j.1526-4637.2012.01479.x. Epub 
      2012 Oct 8.