Value through Innovation27 July 2016

Clinical Study Results

  • MOBIC ® - Osteoarthritis
    Clinical Study Number 107.264
    Study Indication Osteoarthritis
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase IV
    Study Title

    Clinical therapeutic evaluation program in patients with osteomuscular diseases.

    Study Document Trial synopsis 107.264_CO english
  • MOBIC ® - Arthritis, Rheumatoid
    Clinical Study Number 107.258
    Study Indication Arthritis, Rheumatoid
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase III
    Study Title

    A Multi-Center, Double-Blind, Randomized, Parallel-Group Trial to Compare the Efficacy and Safety of Three Doses of Meloxicam (7.5, 15, and 22.5 mg) and Placebo in Patients with Rheumatoid Arthritis

    Study Document Trial synopsis 107.258_CO english
  • MOBIC ® - Osteoarthritis
    Clinical Study Number 107.265
    Study Indication Osteoarthritis
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, open-labelled study to compare the efficacy and safety of meloxicam 7.5 mg IM ampoules once daily and meloxicam 7.5 mg tablets administered orally once daily over a period of 7 days in patients with osteoarthritis (OA).

    Study Document Trial synopsis 107.265_CO english
  • MOBIC ® - Arthritis, Rheumatoid
    Clinical Study Number 107.266
    Study Indication Arthritis, Rheumatoid
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase III
    Study Title

    A randomized, open-labelled study to compare the efficacy and safety of meloxicam 15 mg IM ampoules once daily and meloxicam 15 mg tablets administered orally once daily over a period of 7 days in patients with RA.

    Study Document Trial synopsis 107.266_CO english
  • MOBIC ® - Arthritis, Rheumatoid
    Clinical Study Number 107.267
    Study Indication Arthritis, Rheumatoid
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase IV
    Study Title

    Meloxicam (MOBIC®) ampoule post marketing surveillance study

    Study Document Trial synopsis 107.267_CO english
  • MOBIC ® - Osteoarthritis
    Clinical Study Number 107.273
    Study Indication Osteoarthritis
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase IV
    Study Title

    Assessing the impact of MOVALIS® on Health Related Quality of Life

    Study Document Trial synopsis 107.273 english
  • MOBIC ® - Arthritis, Juvenile
    Clinical Study Number 107.208
    Study Indication Arthritis, Juvenile
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase III
    Study Title

    A one year double-blind trial to investigate the efficacy and safety of meloxicam oral suspension 0.25 mg/kg and 0.125 mg/kg administered once daily in comparison to naproxen oral suspension 5 mg/kg administered twice daily in children with Juvenile Rheumatoid Arthritis

    Study Document Trial synopsis 107.208_CO english
  • MOBIC ® - Arthritis, Juvenile
    Clinical Study Number 107.235
    Study Indication Arthritis, Juvenile
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase III
    Study Title

    A 12 week double-blind randomized trial, with a 12 week open-label extension, to investigate the efficacy and safety of meloxicam oral suspension administered once daily and naproxen oral suspension administered twice daily in children with Juvenile Rheumatoid Arthritis

    Study Document Trial synopsis 107.235_CO english
  • MOBIC ® - Arthritis, Rheumatoid
    Clinical Study Number 107.245
    Study Indication Arthritis, Rheumatoid
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase IV
    Study Title

    COX-2 postmarketing surveillance study with MOBEC® 15 mg tablets

    Study Document Trial synopsis 107.245_CO english
  • MOBIC ® - Healthy
    Clinical Study Number 107.274
    Study Indication Healthy
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase I
    Study Title

    A randomized, single-dose, two-way crossover study to assess the bioequivalence of Meloxicam capsules 15 mg (Mobic Capsules 15 mg) versus Meloxicam tablets 15 mg (Mobic Tablets 15 mg) administered to healthy adult volunteers

    Study Document Trial synopsis 107.274_CO english
  • MOBIC ® - Rheumatic Diseases
    Clinical Study Number 107.272
    Study Indication Rheumatic Diseases
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase IV
    Study Title

    Clinical and therapeutic evaluation of Meloxicam in Mexican patients with rheumatic diseases

    Study Document Trial synopsis 107.272 english
  • MOBIC ® - Healthy
    Clinical Study Number 107.260
    Study Indication Healthy
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence study of UH-AC 62 XX tablets 10 mg (TF4) compared with the 10 mg capsule formulations following single peroral administration in healthy volunteers

    Study Document Trial synopsis 107.260_CO english
  • MOBIC ® - Healthy
    Clinical Study Number 107.259
    Study Indication Healthy
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence study of UHAC 62 XX 10 mg tablets compared with 10 mg capsules following multiple peroral administration in healthy volunteers (An open-label, randomised, two-way crossover study)

    Study Document Trial synopsis 107.259_CO english
  • MOBIC ® - Healthy
    Clinical Study Number 107.255
    Study Indication Healthy
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase I
    Study Title

    Effect of steady state meloxicam 15 mg/day on low dose aspirin (100 mg/day) induced inhibition of platelet aggregation and thromboxane synthesis in healthy males and females. An open, randomised, two-way crossover study.

    Study Document Trial synopsis 107.255 english
  • MOBIC ® - Healthy
    Clinical Study Number 107.254
    Study Indication Healthy
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase I
    Study Title

    An open, randomised, four-way crossover study in healthy volunteers to evaluate the effect of food on the pharmacokinetics of meloxicam after a single p.o. administration of 22.5 mg meloxicam oral suspension and dose-proportionality over a dosage range of 7.5 mg to 22.5 mg.

    Study Document Trial synopsis 107.254 english
  • MOBIC ® - Healthy
    Clinical Study Number 107.252
    Study Indication Healthy
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence study of UHAC 62 XX 10 mg tablets compared with 10mg capsules following single peroral administration in healthy volunteers (An open-label, randomised, two-way crossover study)

    Study Document Trial synopsis 107.252_CO english
  • MOBIC ® - Healthy
    Clinical Study Number 107.251
    Study Indication Healthy
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase I
    Study Title

    Preliminary bioequivalence study of UHAC 62 XX tablets compared with a capsule formulation

    Study Document Trial synopsis 107.251_CO english
  • MOBIC ® - Respiratory Tract Infections
    Clinical Study Number 107.250
    Study Indication Respiratory Tract Infections
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase IV
    Study Title

    Randomized, open-label, controlled trial to assess the clinical efficacy and safety of meloxicam suspension 0.25 mg/kg/day once a day, versus diclofenac 1 mg/kg/day twice a day or nimesulide 4 mg/kg/day twice a day, for five days in the treatment of patients with acute, non-bacterial pharyngitis, pharyngotonsillitis or laryngitis

    Study Document Trial synopsis 107.250 english
  • MOBIC ® - Arthritis, Rheumatoid
    Clinical Study Number 107.246
    Study Indication Arthritis, Rheumatoid
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase IV
    Study Title

    Safety and efficacy of meloxicam (MOBIC) compared to other NSAIDs in approved therapeutic dosages and routes of administration in an observational cohort study of patients with Rheumatoid arthritis, Osteoarthritis, Lumbago, Scapulohumerla periarthritis, Neck, shoulder and arm syndrome

    Study Document Trial synopsis 107.246 english
  • MOBIC ® - Healthy
    Clinical Study Number 107.243
    Study Indication Healthy
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase I
    Study Title

    An open, randomised, four-way crossover study in healthy volunteers to evaluate the effect of food on the pharmacokinetics of meloxicam after a single p.o. administration of 22.5 mg meloxicam oral suspension and dose-proportionality over a dosage range of 7.5 mg to 22.5 mg.

    Study Document Trial synopsis 107.243 english
  • MOBIC ® - Healthy
    Clinical Study Number 107.236
    Study Indication Healthy
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase IIIb/IV
    Study Title

    A double-blind, randomized, parallel group trial to compare the effect of three doses of meloxicam (7.5, 15, and 30 mg) with placebo on bleeding time in healthy male volunteers; and with indomethacin 75 mg (open-label) as an active control to assess trial sensitivity

    Study Document Trial synopsis 107.236_CO english
  • MOBIC ® - Healthy
    Clinical Study Number 107.234
    Study Indication Healthy
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of 7.5 mg Mobic tablet manufactured in China in comparison with 7.5 mg tablet manufactured in Germany after a single oral dose in Chinese healthy volunteers. Open, randomised, two-way cross-over trial.

    Study Document Trial synopsis 107.234 english
  • MOBIC ® - Osteoarthritis
    Clinical Study Number 107.229
    Study Indication Osteoarthritis
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase IV
    Study Title

    Open label study to assess the efficacy and safety of meloxicam 7.5mg vs. diclofenac 100 mg SR in patients with osteoarthritis of the knee

    Study Document Trial synopsis 107.229_CO english
  • MOBIC ® - Osteoarthritis
    Clinical Study Number 107.228
    Study Indication Osteoarthritis
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase IV
    Study Title

    Open study to assess the efficacy and safety of meloxicam 7.5mg in patients with osteoarthritis of the knee

    Study Document Trial synopsis 107.228_CO english
  • MOBIC ® - Healthy
    Clinical Study Number 107.226
    Study Indication Healthy
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase I
    Study Title

    An open, randomized, three-way cross-over study in healthy volunteers to evaluate the relative bioavailability of meloxicam after single p.o. administration of 2x7.5 mg meloxicam tablets compared to 15 mg meloxicam tablet, and dose-proportionality over a dosage range of 7.5 mg and 15 mg.

    Study Document Trial synopsis 107.226 english
  • MOBIC ® - Healthy
    Clinical Study Number 107.224
    Study Indication Healthy
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase I
    Study Title

    Influence of a high fat breakfast on the pharmacokinetics of UH-AC 62 MU (rapid release tablet) given as an oral single dose of 7.5 mg in healthy subjects (two-way cross-over, randomized, open).

    Study Document Trial synopsis 107.224 english
  • MOBIC ® - Healthy
    Clinical Study Number 107.217
    Study Indication Healthy
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics and tolerability of a single 15 mg meloxicam dose injected intramuscularly compared to a single oral 15 mg meloxicam tablet in healthy subjects. A two-way cross-over, randomized, open study.

    Study Document Trial synopsis 107.217 english
  • MOBIC ® - Healthy
    Clinical Study Number 107.214
    Study Indication Healthy
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics and tolerability of 2 x 15 mg meloxicam (2x0.3g topical gel) over 7 days compared to 7.5 mg meloxicam tablet (single oral dose) in healthy subjects. A two-way cross-over, randomized, open study.

    Study Document Trial synopsis 107.214 english
  • MOBIC ® - Osteoarthritis
    Clinical Study Number 107.210
    Study Indication Osteoarthritis
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase IIIb
    Study Title

    A Multi-Center, Randomized, Parallel-Group, Open-Label Study to Compare Prescription Non-Steroidal Anti-Inflammatory Drug (NSAID) Changes, Health Care Utilization, Efficacy and Safety of Meloxicam 7.5 mg versus Usual Care Administration of Prescription NSAIDs in a Managed Healthcare Setting in Patients with Osteoarthritis of the Hip, Knee, Hand or Spine

    Study Document Trial synopsis 107.210 english
  • MOBIC ® - Pain
    Clinical Study Number 107.197
    Study Indication Pain
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase II
    Study Title

    A short term double-blind trial to compare the analgesic efficacy and tolerability of Meloxicam 15 mg, 7.5 mg, 3.75 mg and 1.875 mg oral (rapid release tablet) versus Placebo and Ibuprofen 400 mg and 200 mg oral in the treatment of pain after surgery of the third molar.

    Study Document Trial synopsis 107.197 english
  • MOBIC ® - Pharyngitis
    Clinical Study Number 107.193
    Study Indication Pharyngitis
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase IIb
    Study Title

    Double-blind study to compare efficacy and safety of meloxicam 7.5 mg and 15 mg vs. Naproxen sodium 1100 mg in the symptomatic treatment of acute non bacterial pharyngitis or pharyngo-tonsillitis over a period of 5 days

    Study Document Trial synopsis 107.193 english
  • MOBIC ® - Dysmenorrhea
    Clinical Study Number 107.191
    Study Indication Dysmenorrhea
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase IIb
    Study Title

    Double-blind study to evaluate efficacy and safety of meloxicam 7.5 mg and 15 mg versus mefenamic acid 1500 mg in the treatment of dysmenorrhea.

    Study Document Trial synopsis 107.191 english
  • MOBIC ® - Spondylitis, Ankylosing
    Clinical Study Number 107.237
    Study Indication Spondylitis, Ankylosing
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase IIIb
    Study Title

    A randomized, open label, 3-arm evaluation of efficacy and safety of Meloxicam suppository(15 mg daily) and tablet (15 mg daily) compared to Indomethacin suppository (50 mg daily) in patients with ankylosing spondylitis

    Study Document Trial synopsis 107.237 english
  • MOBIC ® - Arthritis, Rheumatoid
    Clinical Study Number 107.249
    Study Indication Arthritis, Rheumatoid
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase IV
    Study Title

    Personalized Therpeutic Experience Program (Programa de Experiencia Terapeutica Personalizada)

    Study Document Trial synopsis 107.249 english
  • MOBIC ® - Osteoarthritis
    Clinical Study Number 107.270
    Study Indication Osteoarthritis
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase IV
    Study Title

    Post Marketing Surveillance to assess the safety and efficacy of Mobic® (meloxicam) intramuscular injection (7.5mg ~ 15mg, q.d.) up to 3 days (in case of need for prolonged treatment, switch to Mobic® capsule therapy was possible) in Korean patients with osteoarthritis and rheumatoid arthritis (KFDA regulatory requirement PMS)

    Study Document Trial synopsis 107.270 english

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