Value through Innovation27 July 2016

Clinical Study Results

  • THOMAPROFEN ® Plus - Pain, Postoperative
    Clinical Study Number 1335.1
    Study Indication Pain, Postoperative
    Product THOMAPROFEN ® Plus
    Generic Name Ibuprofen + Caffeine
    Lab Code
    Clinical Phase III
    Study Title

    A single-centre, double-blind, randomised, two-stage, parallel group study to assess the efficacy and safety of the fixed dose combination of ibuprofen 400 mg and caffeine 100 mg versus ibuprofen 400 mg, caffeine 100 mg and placebo in patients with postoperative dental pain

    Study Document Trial synopsis 1335.1 english
  • THOMAPROFEN ® Plus - Healthy
    Clinical Study Number 1335.2
    Study Indication Healthy
    Product THOMAPROFEN ® Plus
    Generic Name Ibuprofen + Caffeine
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of ibuprofen from fixed dose combination (FDC) tablet of ibuprofen 400 mg and caffeine 100 mg compared to a tablet of ibuprofen 400 mg and a tablet of ibuprofen lysinate 400 mg following oral administrationin healthy male and female subjects (an open-label, randomised, single-dose,three-period crossover study)

    Study Document Trial synopsis 1335.2_DS english
  • THOMAPROFEN ® Plus - Healthy
    Clinical Study Number 1335.3
    Study Indication Healthy
    Product THOMAPROFEN ® Plus
    Generic Name Ibuprofen + Caffeine
    Lab Code
    Clinical Phase I
    Study Title

    A single center, single dose, open label, randomized, two period, two sequence Crossover Study to evaluate the relative Bioavailability of Ibuprofen from a Fixed Dose Combination Tablet containing Ibuprofen 400 mg and Caffeine 100 mg, and a tablet of Ibuprofen 400 mg in at least 30 healthy males and females under fed conditions

    Study Document Trial synopsis 1335.3 english
  • THOMAPROFEN ® Plus - Pain
    Clinical Study Number 1335.5
    Study Indication Pain
    Product THOMAPROFEN ® Plus
    Generic Name Ibuprofen + Caffeine
    Lab Code
    Clinical Phase III
    Study Title

    A randomized, placebo- and active-controlled multi-country, multi-centre parallel group study to evaluate the efficacy and safety of a fixed dose combination of 400 mg ibuprofen and 100 mg caffeine compared to ibuprofen 400 mg and placebo in patients with acute lower back or neck pain

    Study Document Trial synopsis 1335.5 english

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