Value through Innovation27 July 2016

Clinical Study Results

  • BUSCOPAN ® - Abdominal Pain
    Clinical Study Number 202.838
    Study Indication Abdominal Pain
    Product BUSCOPAN ®
    Generic Name Hyoscine butylbromide
    Lab Code
    Clinical Phase IIIb
    Study Title

    A randomized, double-blind, double-dummy, active-controlled, parallel-group, multicentertrial, in contrast with Hyoscine Butylbromide Capsule 10mg , to evaluate the efficacy and safety of Hyoscine Butylbromide tablets 10 mg (20mg, 3 times daily, orally) over a period of 3 days for the treatment of occasional or recurrent episodes of selfreported gastric or intestinal spasm-like pain

    Study Document Trial synopsis 202.838_CO english
  • BUSCOPAN ® - Abdominal Pain
    Clinical Study Number 202.839
    Study Indication Abdominal Pain
    Product BUSCOPAN ®
    Generic Name Hyoscine butylbromide
    Lab Code
    Clinical Phase II
    Study Title

    A double-blind, placebo controlled, randomized, parallel group study of the efficacy and tolerability of oral doses of 20 mg hyoscine butylbromide when used on demand for the treatment of self reported functional abdominal pain or discomfort associated with cramping

    Study Document Trial synopsis 202.839_CO english
  • BUSCOPAN ® - Colic
    Clinical Study Number 202.832
    Study Indication Colic
    Product BUSCOPAN ®
    Generic Name Hyoscine butylbromide
    Lab Code
    Clinical Phase II
    Study Title

    A double-blind, placebo-controlled, randomized, parallel group study of the efficacy and safety of oral doses of 20 mg hyoscine butylbromide when used on-demand up to 7 episodes over a period of 6 weeks for the treatment of occasional episodes of self reported abdominal pain, cramping, and discomfort associated with cramping in an OTC like study population

    Study Document Trial synopsis 202.832_CO english
  • BUSCOPAN ® - Healthy
    Clinical Study Number 202.846
    Study Indication Healthy
    Product BUSCOPAN ®
    Generic Name Hyoscine butylbromide
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability study to investigate and to compare two different formulations of hyoscine butylbromide, following oral administration in healthy male and female volunteers (an open-label, randomised, single dose, two-way crossover, phase I study)

    Study Document Trial synopsis 202.846_DR english
  • BUSCOPAN ® - Healthy
    Clinical Study Number 202.833
    Study Indication Healthy
    Product BUSCOPAN ®
    Generic Name Hyoscine butylbromide
    Lab Code
    Clinical Phase I
    Study Title

    A randomised, double-blind, placebo-controlled study to assess pharmacokinetics, safety and tolerability of single rising oral doses (20 mg,60 mg, 100 mg, 200 mg and 400 mg) and multiple rising oral doses (3 x 20 mg,3 x 60 mg and 3 x 100 mg per day) of Buscopan® in healthy male volunteers

    Study Document Trial synopsis 202.833_CO english
  • BUSCOPAN ® - Intestinal Diseases
    Clinical Study Number 202.848
    Study Indication Intestinal Diseases
    Product BUSCOPAN ®
    Generic Name Hyoscine butylbromide
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind, independent 3rd party unblind, active-controlled, parallel-group, multi-centre trial, in contrast with anisodamine (654-II), 10 mg, to evaluate the efficacy and safety of Buscopan® solution for injection, 20 mg (intramuscularly) for the treatment of acute gastric or intestinal spasm-like pain

    Study Document Trial synopsis 202.848 english
  • BUSCOPAN ® - Healthy
    Clinical Study Number 202.850
    Study Indication Healthy
    Product BUSCOPAN ®
    Generic Name Hyoscine butylbromide
    Lab Code
    Clinical Phase I
    Study Title

    A single center, single-dose, double-blind, randomized, two period crossover, two stage design to determine bioequivalence of two formulations containing hyoscine butylbromide 10mg sugar coated tablets, under fasting conditions

    Study Document Trial synopsis 202.850 english

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