placebo + moxifloxacin

The combination of placebo and moxifloxacin refers to a specific intervention arm used as a pharmacological positive control in clinical trials, such as the Phase 1 Thorough QT (TQT) study conducted by Ferring Pharmaceuticals for carbetocin. In these regulatory safety studies, moxifloxacin is utilized because it is known to cause a predictable, mild prolongation of the cardiac QT interval, thereby validating the sensitivity of the trial's electrocardiogram (ECG) measurements. Moxifloxacin itself is a synthetic broad-spectrum fluoroquinolone antibiotic. The placebo component is typically administered as an intravenous infusion to match the delivery method of the active test drug (maintaining the study's blinding), while moxifloxacin is usually administered as a single oral dose. This combination is not a therapeutic treatment for postpartum hemorrhage but is a standard requirement for the cardiac safety assessment of drugs being developed for that and other indications.

Other names

moxifloxacin positive control