Trial Outcomes & Findings for Study of PXL01 Versus Placebo to Inhibit Adhesion Formation After Flexor Tendon Surgery (NCT NCT01022242)
NCT ID: NCT01022242
Last Updated: 2014-05-29
Results Overview
The primary variable is TAM2: The sum of Total Active Motion at the proximal interphalangeal (PIP) and distal interphalangeal (DIP) joints of the affected digit at actively made fist minus the extensor lag at these joints.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
138 participants
Primary outcome timeframe
At 12 weeks after surgery
Results posted on
2014-05-29
Participant Flow
Participant milestones
| Measure |
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.
Placebo: Placebo is a physiological sodium chloride solution, which is clear and colourless.
|
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
65
|
|
Overall Study
COMPLETED
|
49
|
46
|
|
Overall Study
NOT COMPLETED
|
21
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of PXL01 Versus Placebo to Inhibit Adhesion Formation After Flexor Tendon Surgery
Baseline characteristics by cohort
| Measure |
Placebo
n=70 Participants
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.
Placebo is a physiological sodium chloride solution, which is clear and colourless.
|
PXL01
n=65 Participants
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.
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.
|
Total
n=135 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
66 Participants
n=93 Participants
|
60 Participants
n=4 Participants
|
126 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=93 Participants
|
48 Participants
n=4 Participants
|
99 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=93 Participants
|
62 Participants
n=4 Participants
|
126 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: At 12 weeks after surgeryPopulation: FAS population
The primary variable is TAM2: The sum of Total Active Motion at the proximal interphalangeal (PIP) and distal interphalangeal (DIP) joints of the affected digit at actively made fist minus the extensor lag at these joints.
Outcome measures
| Measure |
Placebo
n=51 Participants
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.
Placebo is a physiological sodium chloride solution, which is clear and colourless.
|
PXL01
n=50 Participants
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.
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.
|
|---|---|---|
|
TAM2
|
108 Degrees
Interval 36.0 to 175.0
|
121 Degrees
Interval 29.0 to 182.0
|
Adverse Events
Placebo
Serious events: 9 serious events
Other events: 22 other events
Deaths: 0 deaths
PXL01
Serious events: 10 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=70 participants at risk
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.
Placebo is a physiological sodium chloride solution, which is clear and colourless.
|
PXL01
n=65 participants at risk
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.
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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Tendon rupture
|
8.6%
6/70 • Number of events 6
|
7.7%
5/65 • Number of events 5
|
|
Injury, poisoning and procedural complications
procedural pain
|
0.00%
0/70
|
1.5%
1/65 • Number of events 1
|
|
Injury, poisoning and procedural complications
allergic urticaria
|
0.00%
0/70
|
1.5%
1/65 • Number of events 1
|
|
Nervous system disorders
syncope
|
1.4%
1/70 • Number of events 1
|
0.00%
0/65
|
|
Musculoskeletal and connective tissue disorders
adhesion (resulting in tenolysis)
|
2.9%
2/70 • Number of events 2
|
1.5%
1/65 • Number of events 1
|
|
Injury, poisoning and procedural complications
accidental death
|
0.00%
0/70
|
1.5%
1/65 • Number of events 1
|
|
Immune system disorders
myeloproliferative disorder
|
0.00%
0/70
|
1.5%
1/65 • Number of events 1
|
|
Cardiac disorders
stroke
|
0.00%
0/70
|
1.5%
1/65 • Number of events 1
|
Other adverse events
| Measure |
Placebo
n=70 participants at risk
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.
Placebo is a physiological sodium chloride solution, which is clear and colourless.
|
PXL01
n=65 participants at risk
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.
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.
|
|---|---|---|
|
General disorders
Oedema peripheral
|
5.7%
4/70 • Number of events 5
|
7.7%
5/65 • Number of events 5
|
|
Infections and infestations
Nasopharyngitis
|
11.4%
8/70 • Number of events 8
|
10.8%
7/65 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.6%
6/70 • Number of events 6
|
3.1%
2/65 • Number of events 2
|
|
Nervous system disorders
Headache
|
2.9%
2/70 • Number of events 2
|
6.2%
4/65 • Number of events 4
|
|
Infections and infestations
Localised Infections
|
2.9%
2/70 • Number of events 2
|
6.2%
4/65 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60