Phase 2
N=135
Study of PXL01 Versus Placebo to Inhibit Adhesion Formation After Flexor Tendon Surgery
Surgical Adhesions
Bottom Line
View on ClinicalTrials.gov: NCT01022242 ↗Enrolled (actual)
135
Serious AEs
14.1%
Results posted
May 2014
Primary outcome: Primary: TAM2 — 108; 121 Degrees — p=0.8861
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PXL01 (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- Pergamum AB
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY TAM2 |
108; 121 | 0.8861 |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01022242). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.