Value through Innovation27 July 2016

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
  • 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

Clinical Trial Registry and structured study results. Find here protocol information for all clinical study types.

European Trial Register of EU studies.