Value through Innovation27 July 2016

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Clinical Study Results

  • BI 1026706 - Abdominal Pain
    Clinical Study Number 1320.22
    Study Indication Abdominal Pain
    Product BI 1026706
    Generic Name BI 1026706
    Lab Code BI 1026706
    Clinical Phase IIa
    Study Title

    A randomised, double-masked, placebo-controlled exploratory study to evaluate pharmacodynamics, safety, and tolerability of orally administered BI 1026706 for 12 weeks in patients with mild visual impairment due to centre-involved diabetic macular oedema (DME)

    Study Document
    Trial synopsis 1320.22 english
    Lay summary 1320.22 english
    Lay summary 1320.22 dutch
    Lay summary 1320.22 finnish
    Lay summary 1320.22 french
    Lay summary 1320.22 german
    Lay summary 1320.22 greek
    Lay summary 1320.22 hungarian
    Lay summary 1320.22 portuguese
    Lay summary 1320.22 spanish
    Lay summary 1320.22 swedish
  • BI 1026706 - Healthy
    Clinical Study Number 1320.1
    Study Indication Healthy
    Product BI 1026706
    Generic Name BI 1026706
    Lab Code BI 1026706
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of single rising oral doses of BI 1026706 in healthy male volunteers in a partially randomised, single-blind, placebo-controlled trial, and investigation of relative bioavailability of BI 1026706 (open-label, randomised, 4-way cross-over)

    Study Document
    Trial synopsis 1320.1 english
  • BI 1026706 - Healthy , Osteoarthritis
    Clinical Study Number 1320.2
    Study Indication Healthy ; Osteoarthritis
    Product BI 1026706
    Generic Name BI 1026706
    Lab Code BI 1026706
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics of multiple rising oral doses of BI 1026706 in male and female healthy subjects and patients with osteoarthritis of the knee (randomised, double-blind, placebo-controlled within the dose groups, clinical phase I)

    Study Document
    Trial synopsis 1320.2 english
  • BI 1026706 - Healthy
    Clinical Study Number 1320.3
    Study Indication Healthy
    Product BI 1026706
    Generic Name BI 1026706
    Lab Code BI 1026706
    Clinical Phase I
    Study Title

    Effectiveness of two different doses of BI 1026706 on the overall Peak-to-Peak (PtP) N2/P2-component amplitude of Laser (somatosensory, radiant-heat) evoked potentials (LEP) in UVB (ultraviolet)-irradiated skin in healthy male volunteers (a single-blinded, randomised, placebo-controlled, single-dose, five-way crossover study)

    Study Document
    Trial synopsis 1320.3 english
  • BI 1026706 - Pain, Postoperative
    Clinical Study Number 1320.13
    Study Indication Pain, Postoperative
    Product BI 1026706
    Generic Name BI 1026706
    Lab Code BI 1026706
    Clinical Phase I/IIa
    Study Title

    Effectiveness and safety of different doses of BI 1026706 in patients with postoperative dental pain (a single-centre, partially double-blinded, randomised, placebo- and active comparator-controlled, single-dose, parallelgroup study)

    Study Document
    Trial synopsis 1320.13 english
  • BI 1026706 - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1320.16
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BI 1026706
    Generic Name BI 1026706
    Lab Code BI 1026706
    Clinical Phase Ic
    Study Title

    A Phase I randomized, double-blind, placebo-controlled, parallel-group trial of BI 1026706 administered orally as tablets twice daily for 4 weeks to patients with COPD in order to evaluate safety, tolerability, pharmacokinetics and effect on inflammation

    Study Document
    Trial synopsis 1320.16 english
  • BI 1026706 - Healthy
    Clinical Study Number 1320.17
    Study Indication Healthy
    Product BI 1026706
    Generic Name BI 1026706
    Lab Code BI 1026706
    Clinical Phase I
    Study Title

    A randomized, double-blind, placebo-controlled, parallel group, Phase I trial in healthy current smoker subjects to assess pharmacodynamic effects on segmental endotoxin induced inflammatory response and safety of 4 weeks oral administration of BI 1026706

    Study Document
    Trial synopsis 1320.17 english
  • BI 1026706 - Healthy
    Clinical Study Number 1320.20
    Study Indication Healthy
    Product BI 1026706
    Generic Name BI 1026706
    Lab Code BI 1026706
    Clinical Phase I
    Study Title

    Effect of multiple doses of itraconazole on the pharmacokinetics of a single oral dose of BI 1026706 in healthy male subjects (an open-label, randomised, twoperiod, two-sequence crossover study)

    Study Document
    Trial synopsis 1320.20 english
  • BI 1026706 - Healthy
    Clinical Study Number 1320.23
    Study Indication Healthy
    Product BI 1026706
    Generic Name BI 1026706
    Lab Code BI 1026706
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of single rising oral doses and multiple oral doses of BI 1026706 in healthy Chinese and Japanese male volunteers (randomised, double-blind, placebo-controlled trial)

    Study Document
    Trial synopsis 1320.23 english