NCT01022242

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

A Prospective Double-blind, Randomised Concept Study of PXL01 Versus Placebo in Flexor Tendon Surgery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: Pergamum AB · Industry
• Sex: All
• Age: 15 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multi-centre, randomized, double blind, parallel study design in patient admitted for flexor tendon repair in zone II. The patients will undergo 9 visits within the time frame of the study. Patients will be randomized to receive treatment with PXL01 or standard care. Primary objective is to assess total active motion based on PIP and DIP joints (TAM2) at 12-week visit. Secondary objectives are to assess TAM2 at all time points except for 12 weeks, TAM based on MCP, PIP, and DIP joints (TAM3) at all time points, Total Active Motion in DIP joint (DIPAM), tip-to-crease, grip strength and Total Passive Motion (TPM2 and TPM3). Before any study-related assessment takes place, patients are given verbal and written information about the study and informed consent is achieved from the patient and/or legal guardian. The study should be carried out in accordance with the Clinical Study Protocol (CSP), ICH guidelines for Good Clinical Practise (GCP), and applicable regulatory requirements.

Conditions

• Surgical Adhesions

Interventions

Type	Name	Description
DRUG	PXL01	PXL01 is a synthetic peptide sequentially derived from human lactoferrin. PXL01 is formulated in a viscous solution of sodium hyaluronate. The drug product is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.
DRUG	Placebo	Placebo is a physiological sodium chloride solution, which is clear and colourless.

Timeline

• Start date: 2009-12-01
• Primary completion: 2012-05-01
• Completion: 2013-02-01
• First posted: 2009-12-01
• Last updated: 2014-05-29
• Results posted: 2014-05-29

Locations

15 sites across 3 countries: Denmark, Germany, Sweden