CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 138 enrolled
Drug / intervention
PXL01 +1 moredrug
Likely dose
PXL01 0.5 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01022242
NCT01022242Phase 2Completed
CompareCT.gov

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

Pergamum AB·interventional·Posted Dec 1, 2009·Updated May 29, 2014

In Brief

A Phase 2 clinical trial evaluating PXL01 and Placebo for Surgical Adhesions. Completed, enrolled 138 participants across 15 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSurgical Adhesions
CountriesDenmark, Germany, Sweden
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 1, 2009
Enrollment StartDec 1, 2009
Primary CompletionMay 1, 2012
Study CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 16.6 years ago

Interventions

PXL01drug

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.

Placebodrug

Placebo is a physiological sodium chloride solution, which is clear and colourless.