PMID- 25050589
OWN - NLM
STAT- MEDLINE
DCOM- 20150529
LR  - 20181202
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 30
IP  - 9
DP  - 2014 Sep
TI  - Efficacy and safety of low-dose submicron diclofenac for the treatment of 
      osteoarthritis pain: a 12 week, phase 3 study.
PG  - 1883-93
LID - 10.1185/03007995.2014.946123 [doi]
AB  - OBJECTIVE: NSAIDs, such as diclofenac, are the most commonly used medications to 
      treat osteoarthritis (OA), but they are associated with dose-related adverse 
      events (AEs). Low-dose submicron diclofenac was developed using a new, 
      proprietary dry milling process that creates submicron drug particles (SoluMatrix 
      Fine Particle Technology * ), enabling effective treatment at lower doses than 
      other commercially available diclofenac drug products. This phase 3 study 
      evaluated the efficacy and safety of low-dose submicron diclofenac 35 mg three 
      times daily (tid) and twice daily (bid) in patients with OA pain. RESEARCH DESIGN 
      AND METHODS: This double-blind study enrolled patients >/=40 years of age with 
      clinically and radiographically confirmed (Kellgren-Lawrence grade II-III) hip or 
      knee OA. Eligible patients were chronic NSAID and/or acetaminophen (APAP) users 
      with baseline Western Ontario and McMasters Universities Osteoarthritis Index 
      (WOMAC) pain subscale scores >/=40 mm by visual analog scale and an OA flare 
      (>/=15 mm increase in WOMAC pain subscale score following discontinuation of 
      NSAIDs/APAP at screening). Patients were randomized to submicron diclofenac 35 mg 
      tid, submicron diclofenac 35 mg bid, or placebo for 12 weeks. ClinicalTrials.gov 
      identifier: NCT01461369. MAIN OUTCOME MEASURES: Efficacy parameters included mean 
      change from baseline in WOMAC pain subscale score at week 12 (primary efficacy 
      parameter) and in average total WOMAC score over 12 weeks. RESULTS: Submicron 
      diclofenac 35 mg tid significantly improved WOMAC pain subscale scores from 
      baseline at 12 weeks (-44.1; p = 0.0024) compared with placebo (-32.5). Submicron 
      diclofenac 35 mg bid provided numerical improvement in pain at week 12 that did 
      not reach statistical significance (-39.0; p = 0.0795) compared with placebo. 
      Submicron diclofenac 35 mg tid (-35.9; p = 0.0002) and 35 mg bid (-30.3; 
      p = 0.0363) improved the average total WOMAC score in treated patients over 12 
      weeks compared with placebo (-23.2). The most frequent AEs in the submicron 
      diclofenac-treated groups were diarrhea, headache, nausea, and constipation. The 
      inclusion of patients with a documented requirement for analgesic therapy (OA 
      'flare') at baseline and the high rates of rescue medication usage in the placebo 
      group may have impacted the study outcome for the submicron diclofenac treatment 
      groups. CONCLUSIONS: Low-dose submicron diclofenac is an effective therapeutic 
      option for the treatment of OA pain.
FAU - Gibofsky, Allan
AU  - Gibofsky A
AD  - Weill Medical College of Cornell University and Hospital for Special Surgery , 
      New York, NY , USA.
FAU - Hochberg, Marc C
AU  - Hochberg MC
FAU - Jaros, Mark J
AU  - Jaros MJ
FAU - Young, Clarence L
AU  - Young CL
LA  - eng
SI  - ClinicalTrials.gov/NCT01461369
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20140806
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 144O8QL0L1 (Diclofenac)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anti-Inflammatory Agents, Non-Steroidal/*administration & dosage/therapeutic use
MH  - Chemistry, Pharmaceutical
MH  - Diclofenac/*administration & dosage/therapeutic use
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Osteoarthritis, Hip/*drug therapy
MH  - Osteoarthritis, Knee/*drug therapy
MH  - Pain Measurement
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Chronic pain
OT  - Diclofenac capsules
OT  - NSAID
OT  - Osteoarthritis
OT  - Submicron
EDAT- 2014/07/23 06:00
MHDA- 2015/05/30 06:00
CRDT- 2014/07/23 06:00
PHST- 2014/07/23 06:00 [entrez]
PHST- 2014/07/23 06:00 [pubmed]
PHST- 2015/05/30 06:00 [medline]
AID - 10.1185/03007995.2014.946123 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2014 Sep;30(9):1883-93. doi: 10.1185/03007995.2014.946123. 
      Epub 2014 Aug 6.