Value through Innovation27 July 2016

Clinical Study Results

  • BI 660848 - Pain
    Clinical Study Number 1284.1
    Study Indication Pain
    Product BI 660848
    Generic Name BI 660848
    Lab Code
    Clinical Phase I
    Study Title

    A randomised, double-blind, placebo-controlled (within dose groups) Phase I study to a) assess safety, tolerability and pharmacokinetics of single rising oral doses 2 mg to 600 mg of BI 660848 administered as oral drinking solution (powder in bottle) in healthy male volunteers, b) to explore the relative oral bioavailability of an immediate release tablet formulation, c) to assess the impact of a high fat meal on the oral bioavailability of the oral drinking solution (powder in bottle) and d) assess safety, tolerability and pharmacokinetics of single rising oral doses of 800 mg and 1000 mg of BI 660848 administered as 100 mg tablets (800 mg = 8 tablets and 1000 mg = 10 tablets) once daily

    Study Document Statement 1284.1_DR english Trial synopsis 1284.1 english
  • Eschscholzia californica - Pain
    Clinical Study Number 1120.3
    Study Indication Pain
    Product Eschscholzia californica
    Generic Name Eschscholzia californica
    Lab Code
    Clinical Phase II
    Study Title

    Short term double blind randomised controlled study to assess the kinetic of the analgesic effect and the tolerability of Eschscholtzia Califomica 500 mg and 1000 mg versus ibuprofen 200 mg and placebo in the treatment of pain after surgery of the third molar.

    Study Document Trial synopsis 1120.3_CO english
  • LISAGIL ® - Pain
    Clinical Study Number 1093.18
    Study Indication Pain
    Product LISAGIL ®
    Generic Name Metamizole
    Lab Code
    Clinical Phase IV
    Study Title

    Randomized, double blind, comparative trial of the efficacy and tolerability of Nolotil  i.v. vs. Placebo i.v. in the prevention of postoperative pain in children of 6 and 11 years old undergoing minor surgery

    Study Document Trial synopsis 1093.18 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
  • YENTREVE ® - Pain
    Clinical Study Number 1208.31
    Study Indication Pain
    Product YENTREVE ®
    Generic Name Duloxetine
    Lab Code
    Clinical Phase IV
    Study Title

    Post-Marketing Surveillance Study on the Safety and Efficacy of Cymbalta (Duloxetine) on Diabetic Peripheral Neuropathic Pain Among Filipino Patients

    Study Document Trial synopsis 1208.31 english
  • Diclofenac + Capsaicin - Pain
    Clinical Study Number 1358.1
    Study Indication Pain
    Product Diclofenac + Capsaicin
    Generic Name Diclofenac + Capsaicin
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, controlled multi-centre parallel group study to assess the efficacy and safety of multiple doses of a topically applied combination containing diclofenac 2% + capsaicin 0.075% (2 g formulation per application; 2-times daily for 5 days) compared to placebo, as well as to diclofenac 2% and capsaicin 0.075% in patients with acute back or neck pain

    Study Document Trial synopsis 1358.1 english
  • Diclofenac + Capsaicin - Pain
    Clinical Study Number 1358.2
    Study Indication Pain
    Product Diclofenac + Capsaicin
    Generic Name Diclofenac + Capsaicin
    Lab Code
    Clinical Phase I
    Study Title

    A Single Center, Multiple-Dose, Open-Label, Randomized, Three-Period Crossover Study To Determine The Relative Bioavailability Of Diclofenac In The Topical Gel Combination Product (Diclofenac 2% + Capsaicin 0.075%) Compared To Diclofenac Mono Gel 2% And Voltarol® 12 Hour Emulgel 2.32% Gel In At Least 42 Healthy Males And Females

    Study Document Trial synopsis 1358.2 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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