Abstract
Objective: To investigate the TrkA inhibitor, ASP7962, for treatment of painful knee osteoarthritis. Design: Phase 2a, double-blind, placebo- and naproxen-controlled, double-dummy, parallel-group study. Adults with knee osteoarthritis were randomized (2:2:1) to ASP7962 (100 mg), placebo, or naproxen (500 mg) twice daily (BID) for 4 weeks. Primary endpoint: change from baseline to Week 4 in Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale score. Secondary endpoints: change from baseline to Weeks 1, 2, and End of Treatment (EoT) in WOMAC pain subscale score; change from baseline to Weeks 1, 2, 4, and EoT in WOMAC physical function and stiffness subscales, walking pain and WOMAC total scores; and change from baseline in daily average pain score. Results: 215 participants were randomized (ASP7962 100 mg BID, n = 85; placebo, n = 87; naproxen 500 mg BID, n = 43). No significant difference was observed between ASP7962 and placebo in change from baseline to Week 4 in WOMAC pain subscale score (−0.14; 90% 2-sided CI: −0.62, 0.34; P = 0.316); a significant difference was observed between naproxen and placebo (−0.67; 80% 2-sided CI: −1.12, −0.23; P = 0.027). No differences were observed between ASP7962 and placebo in change from baseline in any WOMAC subscale score; statistically significant changes were observed between naproxen and placebo (P ≤ 0.01, all time points for all WOMAC endpoints). ASP7962 was safe and well-tolerated. Conclusions: Four-week treatment with ASP7962 (100 mg BID) did not improve pain or physical function in individuals with painful knee osteoarthritis. ClinicalTrials.gov, NCT02611466; EudraCT Number, 2014-004996-22.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 1590-1598 |
| Number of pages | 9 |
| Journal | Osteoarthritis and Cartilage |
| Volume | 27 |
| Issue number | 11 |
| DOIs | |
| State | Published - Nov 2019 |
Fingerprint
Keywords
- ASP7962
- Knee
- Osteoarthritis
- Pain
- Physical function
- TrkA inhibitor
ASJC Scopus subject areas
- Rheumatology
- Biomedical Engineering
- Orthopedics and Sports Medicine
Cite this
Tropomyosin-related kinase A (TrkA) inhibition for the treatment of painful knee osteoarthritis : results from a randomized controlled phase 2a trial. / Watt, F. E.; Blauwet, M. B.; Fakhoury, A.; Jacobs, H.; Smulders, R.; Lane, N. E.
In: Osteoarthritis and Cartilage, Vol. 27, No. 11, 11.2019, p. 1590-1598.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Tropomyosin-related kinase A (TrkA) inhibition for the treatment of painful knee osteoarthritis
T2 - results from a randomized controlled phase 2a trial
AU - Watt, F. E.
AU - Blauwet, M. B.
AU - Fakhoury, A.
AU - Jacobs, H.
AU - Smulders, R.
AU - Lane, N. E.
PY - 2019/11
Y1 - 2019/11
N2 - Objective: To investigate the TrkA inhibitor, ASP7962, for treatment of painful knee osteoarthritis. Design: Phase 2a, double-blind, placebo- and naproxen-controlled, double-dummy, parallel-group study. Adults with knee osteoarthritis were randomized (2:2:1) to ASP7962 (100 mg), placebo, or naproxen (500 mg) twice daily (BID) for 4 weeks. Primary endpoint: change from baseline to Week 4 in Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale score. Secondary endpoints: change from baseline to Weeks 1, 2, and End of Treatment (EoT) in WOMAC pain subscale score; change from baseline to Weeks 1, 2, 4, and EoT in WOMAC physical function and stiffness subscales, walking pain and WOMAC total scores; and change from baseline in daily average pain score. Results: 215 participants were randomized (ASP7962 100 mg BID, n = 85; placebo, n = 87; naproxen 500 mg BID, n = 43). No significant difference was observed between ASP7962 and placebo in change from baseline to Week 4 in WOMAC pain subscale score (−0.14; 90% 2-sided CI: −0.62, 0.34; P = 0.316); a significant difference was observed between naproxen and placebo (−0.67; 80% 2-sided CI: −1.12, −0.23; P = 0.027). No differences were observed between ASP7962 and placebo in change from baseline in any WOMAC subscale score; statistically significant changes were observed between naproxen and placebo (P ≤ 0.01, all time points for all WOMAC endpoints). ASP7962 was safe and well-tolerated. Conclusions: Four-week treatment with ASP7962 (100 mg BID) did not improve pain or physical function in individuals with painful knee osteoarthritis. ClinicalTrials.gov, NCT02611466; EudraCT Number, 2014-004996-22.
AB - Objective: To investigate the TrkA inhibitor, ASP7962, for treatment of painful knee osteoarthritis. Design: Phase 2a, double-blind, placebo- and naproxen-controlled, double-dummy, parallel-group study. Adults with knee osteoarthritis were randomized (2:2:1) to ASP7962 (100 mg), placebo, or naproxen (500 mg) twice daily (BID) for 4 weeks. Primary endpoint: change from baseline to Week 4 in Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale score. Secondary endpoints: change from baseline to Weeks 1, 2, and End of Treatment (EoT) in WOMAC pain subscale score; change from baseline to Weeks 1, 2, 4, and EoT in WOMAC physical function and stiffness subscales, walking pain and WOMAC total scores; and change from baseline in daily average pain score. Results: 215 participants were randomized (ASP7962 100 mg BID, n = 85; placebo, n = 87; naproxen 500 mg BID, n = 43). No significant difference was observed between ASP7962 and placebo in change from baseline to Week 4 in WOMAC pain subscale score (−0.14; 90% 2-sided CI: −0.62, 0.34; P = 0.316); a significant difference was observed between naproxen and placebo (−0.67; 80% 2-sided CI: −1.12, −0.23; P = 0.027). No differences were observed between ASP7962 and placebo in change from baseline in any WOMAC subscale score; statistically significant changes were observed between naproxen and placebo (P ≤ 0.01, all time points for all WOMAC endpoints). ASP7962 was safe and well-tolerated. Conclusions: Four-week treatment with ASP7962 (100 mg BID) did not improve pain or physical function in individuals with painful knee osteoarthritis. ClinicalTrials.gov, NCT02611466; EudraCT Number, 2014-004996-22.
KW - ASP7962
KW - Knee
KW - Osteoarthritis
KW - Pain
KW - Physical function
KW - TrkA inhibitor
UR - http://www.scopus.com/inward/record.url?scp=85070906833&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85070906833&partnerID=8YFLogxK
U2 - 10.1016/j.joca.2019.05.029
DO - 10.1016/j.joca.2019.05.029
M3 - Article
C2 - 31356878
AN - SCOPUS:85070906833
VL - 27
SP - 1590
EP - 1598
JO - Osteoarthritis and Cartilage
JF - Osteoarthritis and Cartilage
SN - 1063-4584
IS - 11
ER -