Search results for "Study drug"
showing 4 items of 4 documents
FRI0265 Selexipag in Raynaud's Phenomenon Secondary To Systemic Sclerosis: A Randomised, Placebo-Controlled, Phase II Study
2016
Background Raynaud9s phenomenon (RP) occurs in >95% of patients (pts) with systemic sclerosis (SSc) and contributes to digital ischaemia that may lead to digital ulcers (DUs) and gangrene.1,2 Empirical treatment of SSc-associated RP includes oral vasodilators, particularly calcium channel blockers and intermittent intravenous prostacyclin analogues.3,4 However, there is a need to identify oral therapies that are more efficacious than those currently available. Objectives To determine the activity of selexipag, an oral, selective, prostacyclin receptor agonist, on RP attack frequency in pts with SSc. Methods The study comprised a placebo single-blind run-in phase of 2–4-weeks followed by an …
Drugs and the Colon
1983
It is not our intention to review drug effects in the colon, which was done extensively and profoundly by Forth and Rummel1 and Powell.2 Our contribution will present studies of drug effects on physiological absorption and secretion processes obtained in the intact human colon and based on results of intestinal perfusion studies of the whole colon and measurements of transepithelial electrical potential difference (PD) in the rectosigmoid colon. These are at present the practiced and—regarding perfusion studies—most accurate techniques in the hands of clinicians to directly study drug effects on a local dose-response scale in the intact human colon. Since these methods are relatively new an…
Emergency Clinical Trials
2010
Emergency clinical trials involve the administration of the study drug to healthy human volunteers or to patients under the supervision of a qualified investigator, usually a physician, pursuant to a reviewed protocol. Research in this field continues to grow because this department is often considered as a desirable place to conduct clinical research due to the broad and undifferentiated spectrum of acute conditions encountered. There are some specific aspects when studying emergency medicine that have to be taken into account. One of them is the emphasis on ultrarapid diagnosis and treatment to save the critically ill emergency patient. Keywords: emergency medicine; clinical trials; diagn…
Narratives of Patients with Fatal Outcomes During the Phase 2 TITAN and Phase 3 HERCULES Studies
2019
Background: Acquired thrombotic thrombocytopenic purpura (aTTP) is a rare but life-threatening thrombotic microangiopathy, with an untreated mortality rate of >90%. Prompt treatment with therapeutic plasma exchange (TPE) and immunosuppression improves outcomes in patients with aTTP, but 10-20% of patients still die acutely from this disease. The aim of this analysis was to describe in more detail the characteristics and disease courses of the patients who died during the caplacizumab clinical development program. Methods: Patient narratives on all deaths occurring during the phase 2 TITAN and phase 3 HERCULES studies were extracted. Results: In the overall study periods, a total of 6 pat…