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Statistische Auswertung

Statistische Auswertung

Ob klinische Studien der Phasen I bis IV, Datenerhebungen in der Arzneimittelanwendungsforschung oder Arzneimittelepidemiologie oder Analysen aus bestehenden Datenbeständen - wir finden die Antworten auf Ihre Fragen im Bereich Statistik.

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In einer komplexen Welt aus regulatorischen Anforderungen und studienindividuellen Lösungsansätzen streben wir an, auch für besondere Situationen funktionierende Lösungen zu bieten. Die Szenarien reichen hier von einem adaptiven Studiendesigns bis hin zu komplexen Auswertungsansätzen. Zu diesem Service gehört nach unserem Selbstverständnis auch die offene und umfassend betreute Einbindung externer Expertise, insbesondere durch Kooperationen mit unseren langjährigen Partnern.

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Our study with Staatl. Fachingen STILL has been published!

We are very pleased! Our study with Staatl. Fachingen STILL has been published!

It was a matter close to our hearts to prove the effectiveness of Staatl. Fachingen STILL for heartburn in a very exciting and logistically challenging study project. Many of us still know this healing water from the days when it was sold through pharmacies and often ridiculed. With great enthusiasm, The study teams of SocraTec R&D and SocraMetrics realized this unusual study: in a double-blind, randomized, placebo-controlled study, we were able to show, together with our client, that this bicarbonate-rich mineral water really does help with heartburn. The IMP logistics was a real challenge!

In an efficacy trial with adaptive design - a multicentre, double-blind, randomised, placebo-controlled trial STOMACH STILL with interim analysis - adult patients with frequent heartburn episodes since ≥6 months and without moderate/severe reflux oesophagitis drank 1.5 L/day verum or placebo over the course of the day for 6 weeks. Primary endpoint was the percentage of patients with reduction of ≥5 points in the Reflux Disease Questionnaire (RDQ) score for ‘heartburn’. Secondary endpoints included symptom reduction (RDQ), health-related quality of life (HRQOL, Quality of Life in Reflux and Dyspepsia (QOLRAD)), intake of rescue medication and safety/tolerability.

Out of 148 randomised patients (verum: n=73, placebo: n=75), 143 completed the trial. Responder rates were 84.72% in the verum and 63.51% in the placebo group – a common magnitude of a placebo-effect in this indication. Symptoms improved under verum compared with placebo for the dimension ‘heartburn’ (p=0.0003) and the RDQ total score (p=0.0050). HRQOL improvements under verum compared with placebo were reported for 3 of 5 QOLRAD domains, that is, ‘food/drink problems’ (p=0.0125), ‘emotional distress’ (p=0.0147) and ‘vitality’ (p=0.0393). Mean intake of rescue medication decreased from 0.73 tablets/day at baseline to 0.47 tablets/day in week 6 in the verum group, whereas in the placebo group it remained constant during the trial. Only three patients had treatment-related adverse events (verum: n=1, placebo: n=2). The study could be stopped after interim analysis as efficacy was clearly demonstrated already with 143 subjects.

Great success of the team and the product of course!