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

NCT01022242 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2014-05-29

Study results available
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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.

Conditions

  • Surgical Adhesions

Interventions

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.

Sponsors & Collaborators

  • Pergamum AB

    lead INDUSTRY

Principal Investigators

  • Monica Wiig, MD, PhD · Dept. of Hand Surgery Uppsala University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2012-05-31
Completion
2013-02-28

Countries

  • Denmark
  • Germany
  • Sweden

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01022242 on ClinicalTrials.gov