drugset / Trial / NCT01022242

Study of PXL01 Versus Placebo to Inhibit Adhesion Formation After Flexor Tendon Surgery

NCT01022242 ↗

Phase 2 Completed 138 enrolled Pergamum AB
RandomizedParallel-groupDouble-blindPrevention

Summary

The objectives of the study are to assess efficacy, safety, and handling of PXL01 in patients with flexor tendon injury in zone I or II.

Timeline

Start
2009-12
Primary completion
2012-05
Completion
2013-02

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Placebo vs PXL01; p = 0.8861; ANCOVA NCT01022242 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject ENSEREPTIDE Peptide 0.5 ml Other

Indications

No indication recorded.