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

2014-07-23 21:11:40 | BioPortfolio

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.

Description

This is a multi-centre, randomized, single-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), 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.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Surgical Adhesions

Intervention

PXL01, Placebo

Location

Dept. of Hand Surgery, Aalborg Hospital
Aalborg
Denmark
9000

Status

Recruiting

Source

PharmaSurgics AB

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:11:40-0400

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