PMID- 26503347
OWN - NLM
STAT- MEDLINE
DCOM- 20160711
LR  - 20181202
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 31
IP  - 12
DP  - 2015 Dec
TI  - Efficacy and safety of low-dose SoluMatrix meloxicam in the treatment of 
      osteoarthritis pain: a 12-week, phase 3 study.
PG  - 2331-43
LID - 10.1185/03007995.2015.1112772 [doi]
AB  - OBJECTIVE: Nonsteroidal anti-inflammatory drugs (NSAIDs) such as meloxicam are 
      commonly used to treat osteoarthritis (OA) but are associated with potentially 
      serious dose-related adverse events (AEs). SoluMatrix meloxicam has been 
      developed with the goal of enabling effective treatment at low doses. This phase 
      3 study evaluated the efficacy and safety of low-dose SoluMatrix meloxicam 
      capsules 5 mg and 10 mg administered once daily for 12 weeks in patients with 
      OA-related pain. RESEARCH DESIGN AND METHODS: This randomized, double-blind study 
      enrolled patients >/=40 years of age with confirmed hip or knee OA 
      (Kellgren-Lawrence grade II-III) who were chronic users of NSAIDs and/or 
      acetaminophen for OA pain and had Western Ontario and McMaster Universities 
      Osteoarthritis Index (WOMAC) pain subscale mean scores >/=40 mm. Eligible patients 
      experienced an OA pain flare (defined as a >/=15 mm increase in the WOMAC pain 
      subscale score) following discontinuation of NSAIDs/acetaminophen. Patients were 
      randomized to receive once-daily SoluMatrix meloxicam 5 mg or 10 mg, or placebo 
      for 12 weeks. ClinicalTrials.gov identifier: NCT01787188. MAIN OUTCOME MEASURES: 
      The primary outcome measure was the mean change from baseline in WOMAC pain 
      subscale score at week 12. RESULTS: Low-dose SoluMatrix meloxicam 5 mg (-36.52 
      [2.49]; P = 0.0005) and 10 mg (-34.41 [2.68]; P = 0.0059) once-daily treatment 
      significantly reduced the mean (standard error) WOMAC pain subscale score from 
      baseline at week 12 compared with placebo (-25.68 [2.64]). Patients treated with 
      SoluMatrix meloxicam 5 mg or 10 mg reported significantly greater improvements in 
      total WOMAC score and in WOMAC stiffness and function subscale scores at 12 weeks 
      compared with placebo. The most common AEs in the combined low-dose SoluMatrix 
      meloxicam group were headache, diarrhea, nausea, osteoarthritis, and urinary 
      tract infection. CONCLUSIONS: Low-dose SoluMatrix meloxicam may have a potential 
      role as a new therapeutic option for the management of OA-related pain.
FAU - Altman, Roy
AU  - Altman R
AD  - a a University of California, David Geffen School of Medicine , Los Angeles , CA 
      , USA.
FAU - Hochberg, Marc
AU  - Hochberg M
AD  - b b University of Maryland School of Medicine , Baltimore , MD , USA.
FAU - Gibofsky, Allan
AU  - Gibofsky A
AD  - c c Hospital for Special Surgery , New York , NY , USA.
FAU - Jaros, Mark
AU  - Jaros M
AD  - d d Summit Analytical LLC , Denver , CO , USA.
FAU - Young, Clarence
AU  - Young C
AD  - e e Iroko Pharmaceuticals, LLC , Philadelphia , PA , USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01787188
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 0 (Thiazines)
RN  - 0 (Thiazoles)
RN  - 362O9ITL9D (Acetaminophen)
RN  - VG2QF83CGL (Meloxicam)
SB  - IM
MH  - Acetaminophen/therapeutic use
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anti-Inflammatory Agents, Non-Steroidal/administration & dosage/adverse effects
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Meloxicam
MH  - Middle Aged
MH  - Osteoarthritis, Hip/*drug therapy
MH  - Osteoarthritis, Knee/*drug therapy
MH  - Pain/*drug therapy
MH  - Pain Measurement
MH  - Thiazines/*administration & dosage/adverse effects
MH  - Thiazoles/*administration & dosage/adverse effects
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Chronic pain
OT  - Low-dose SoluMatrix meloxicam
OT  - NSAIDs
OT  - Osteoarthritis
EDAT- 2015/10/28 06:00
MHDA- 2016/07/12 06:00
CRDT- 2015/10/28 06:00
PHST- 2015/10/28 06:00 [entrez]
PHST- 2015/10/28 06:00 [pubmed]
PHST- 2016/07/12 06:00 [medline]
AID - 10.1185/03007995.2015.1112772 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2015 Dec;31(12):2331-43. doi: 10.1185/03007995.2015.1112772.