Study of PXL01 Versus Placebo to Inhibit Adhesion Formation After Flexor Tendon Surgery (PHSU02)
This study is ongoing, but not recruiting participants.
Sponsor:
Pergamum AB
Information provided by (Responsible Party):
Pergamum AB
ClinicalTrials.gov Identifier:
NCT01022242
First received: November 25, 2009
Last updated: December 4, 2012
Last verified: December 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Surgical Adhesions |
Drug: PXL01 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | A Prospective Double-blind, Randomised Concept Study of PXL01 Versus Placebo in Flexor Tendon Surgery |
Resource links provided by NLM:
Further study details as provided by Pergamum AB:
Primary Outcome Measures:
- The primary variable is Total Active Motion (TAM) at the proximal interphalangeal (PIP), and distal interphalangeal (DIP) joints (i.e. TAM2) of the affected digit at actively made fist at 12 weeks after surgery. [ Time Frame: from administration until 12 months after. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The secondary objectives are to evaluate additional efficacy variables and safety, including rupture rate, of a single local administration of PXL01 in sodium hyaluronate in patients with a flexor tendon injury in zone I or II. [ Time Frame: from administration until 12 months after. ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 138 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | February 2013 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Placebo 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.
|
|
Experimental: PXL01
PXL01 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: 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.
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 15 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Complete division of flexor digitorium profundus tendon (FDP) in zone I or II, with or without division of flexor digitorium superficialis (FDS) and possible to rejoin with tendon suture
- Open flexor tendon injury sutured within 14 days after trauma
- 12-75 years of age
- Signed informed consent prior to any study related procedures
Exclusion criteria
- Treatment with any investigational product within 4 weeks of study entry
- Patients previously included in the study
- Thumbs with complete or partial division of flexor pollicis longus (FPL)
- Concomitant fracture(s) requiring immobilisation
- Injuries with associated soft tissue loss
- Severe crush injury
- Palmar plate injury requiring immobilisation
- Devascularisation/requirement of vascular repair
- Joint injuries
- Bilateral injuries
- Previous flexor tendon surgery in the digit, which is to be treated with IMP
- Reduced motion in the digit, which is to be treated with IMP, or the corresponding digit prior to the injury
- Compliance with mobilisation protocol not expected
- Alcohol or drug abuse
- Severe intercurrent illness, which in the opinion of the Investigator, may put the patient at risk when participating in the study, or affect the patient's ability to take part in the study
- Pregnant or lactating females
- Fertile women who do not accept the consistent and correct use of highly effective methods of birth control defined as implants, injectables, combined oral contraceptives, intra-uterine device (IUD)s, sexual abstinence or vasectomised partner during the first two weeks post-surgery. A condom alone is not considered an acceptable method for birth control, not even together with spermicide.
- Known allergy to any component of the study product or placebo
Patients suffering from:
- Diabetes Mellitus patients where significant diabetic complications may delay healing according to the investigator's judgement
- Rheumatoid arthritis
Or patients treated with:
- Systemic steroids within one month
- Immunosuppressive drugs within three months
- Daily use of NSAIDs within one week or occasional use within 8 hours
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01022242
Locations
| Denmark | |
| Dept. of Hand Surgery, Aalborg Hospital | |
| Aalborg, Denmark, 9000 | |
| Dept. of Hand Surgery, Odense University Hospital | |
| Odense, Denmark, 5000 | |
| Germany | |
| Klinik für Handchirurgie der Herz- und Gefäß-Klinik GmbH | |
| Bad Neustadt, Germany, 97616 | |
| Katholisches Klinikum Duisburg, St. Barbara Hospital, Klinik für Plastische Chirurgie und Handchirurgie | |
| Duisburg, Germany, 47166 | |
| St.Josef Hospital Essen- Kupferdreh, Abteilung für Handchirurgie | |
| Essen, Germany, 45257 | |
| Klinik für Plastische, Hand- und Wiederherstellungschirurgie, Medizinische Hochschule Hannover | |
| Hannover, Germany, 30625 | |
| Universitätsklinikum des Saarlandes, Klinik für Unfall-, Hand - und Wiederherstellungschirugie | |
| Homburg, Germany, 66421 | |
| Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Sektion für Plastische Chirurgie, Handchirurgie und Intensiveinheit für Schwerbrandverletzte | |
| Lübeck, Germany, 23538 | |
| Ludwig-Maximilians Universität München, Klinik und Poliklinik für Plastische Chirurgie und Handchirurgie, Campus Innenstadt | |
| Munich, Germany, 80336 | |
| Ludwig-Maximilians Universität München, Klinik und Poliklinik für Plastische Chirurgie und Handchirurgie, Campus Großhadern | |
| Munich, Germany, 81377 | |
| Klinik für Handchirurgie, Mikrochirurgie und Rekonstruktive Brustchirurgie Vinzenz von Paul Kliniken GmbH | |
| Stuttgart, Germany, 70199 | |
| Sweden | |
| Dept. of Hand Surgery Sahlgrenska University Hospital | |
| Gothenburg, Sweden, SE-413 45 | |
| Dept. of Hand Surgery Malmö University Hospital | |
| Malmö, Sweden, SE-20502 | |
| Dept. of Hand Surgery, Stockholm South General Hospital | |
| Stockholm, Sweden, 118 83 | |
| Dept. of Hand Surgery Uppsala University Hospital, entrance 70 | |
| Uppsala, Sweden, SE-75185 | |
Sponsors and Collaborators
Pergamum AB
Investigators
| Principal Investigator: | Monica Wiig, MD, PhD | Dept. of Hand Surgery Uppsala University Hospital |
More Information
No publications provided
| Responsible Party: | Pergamum AB |
| ClinicalTrials.gov Identifier: | NCT01022242 History of Changes |
| Other Study ID Numbers: | PHSU02 |
| Study First Received: | November 25, 2009 |
| Last Updated: | December 4, 2012 |
| Health Authority: | Sweden: Medical Products Agency Denmark: Danish Madicines Agency Germany: BfArm |
Keywords provided by Pergamum AB:
|
Surgical Adhesions Post-surgical adhesions Flexor tendon |
Additional relevant MeSH terms:
|
Tissue Adhesions Cicatrix Fibrosis Pathologic Processes |
ClinicalTrials.gov processed this record on June 17, 2013