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Synonym: phase-2-trial
German: Phase-II-Studie

1 Definition

The phase-II-trial is a clinical trial where the active substance candidate is used in patients that suffer from the target disease for the first time.

2 Background

In the course of phase-II-trials, producers cooperate with hospitals and other medial institutions. Typically, around 100 to 500 patients volunteer as subjects for the investigations. In phase-II-trials, you verify

  • if the desired therapeutic effect shows (efficacy)
  • which side effects occur (tolerance)
  • which dosage is best (dose finding)

3 Classification

Phase-II-trials can be further divided into:

  • Phase-IIa-trials: The serve the verification of the therapeutic concept ("proof of concept")
  • Phase-IIb-trials: They serve the finding of the appropriate therapeutic dose ("dose finding")

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