A randomized clinical trial to evaluate two doses of an intra-articular injection of LMWF-5A in adults with pain due to osteoarthritis of the knee.
<h4>Objective</h4>The Low Molecular Weight Fraction of 5% human serum Albumin (LMWF-5A) is being investigated as a treatment for knee pain from osteoarthritis.<h4>Methods</h4>This was a multicenter randomized, vehicle-controlled, double-blind, parallel study designed to evalu...
Saved in:
| Main Authors: | , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Public Library of Science (PLoS)
2014-01-01
|
| Series: | PLoS ONE |
| Online Access: | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0087910&type=printable |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849468613339119616 |
|---|---|
| author | David Bar-Or Kristin M Salottolo Holli Loose Matthew J Phillips Brian McGrath Nathan Wei James L Borders John E Ervin Alan Kivitz Mark Hermann Tammi Shlotzhauer Melvin Churchill Donald Slappey Vaughan Clift |
| author_facet | David Bar-Or Kristin M Salottolo Holli Loose Matthew J Phillips Brian McGrath Nathan Wei James L Borders John E Ervin Alan Kivitz Mark Hermann Tammi Shlotzhauer Melvin Churchill Donald Slappey Vaughan Clift |
| author_sort | David Bar-Or |
| collection | DOAJ |
| description | <h4>Objective</h4>The Low Molecular Weight Fraction of 5% human serum Albumin (LMWF-5A) is being investigated as a treatment for knee pain from osteoarthritis.<h4>Methods</h4>This was a multicenter randomized, vehicle-controlled, double-blind, parallel study designed to evaluate the safety and efficacy of two doses of an intra-articular injection of LMWF-5A. Patients with symptomatic knee osteoarthritis were randomized 1∶1∶1∶1 to receive a single 4 mL or 10 mL intra-articular knee injection of either LMWF-5A or vehicle control (saline). The primary efficacy endpoint was the difference between treatment groups in the Western Ontario and McMaster Universities (WOMAC) pain change from baseline over 12 weeks. Safety was examined as the incidence and severity of adverse events (AEs).<h4>Results</h4>A total of 329 patients were randomized and received treatment. LMWF-5A resulted in a significant decrease in pain at 12 weeks compared to vehicle control (-0.93 vs -0.72; estimated difference from control: -0.25, p = 0.004); an injection volume effect was not observed (p = 0.64). The effect of LMWF-5A on pain was even more pronounced in patients with severe knee OA (Kellgren Lawrence Grade IV): the estimated difference from control was -0.42 (p = 0.02). Adverse events were generally mild and were similar in patients who received vehicle control (47%) and LMWF-5A (41%).<h4>Conclusions</h4>This clinical trial demonstrated that LMWF-5A is safe and effective at providing relief for the pain of moderate to severe OA of the knee over 12 weeks when administered by intra-articular injection into the knee.<h4>Trial registration</h4>ClinicalTrials.gov NCT01839331. |
| format | Article |
| id | doaj-art-e1bfdd55b30146dd8a4e9e777b17fbcc |
| institution | Kabale University |
| issn | 1932-6203 |
| language | English |
| publishDate | 2014-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj-art-e1bfdd55b30146dd8a4e9e777b17fbcc2025-08-20T03:25:47ZengPublic Library of Science (PLoS)PLoS ONE1932-62032014-01-0192e8791010.1371/journal.pone.0087910A randomized clinical trial to evaluate two doses of an intra-articular injection of LMWF-5A in adults with pain due to osteoarthritis of the knee.David Bar-OrKristin M SalottoloHolli LooseMatthew J PhillipsBrian McGrathNathan WeiJames L BordersJohn E ErvinAlan KivitzMark HermannTammi ShlotzhauerMelvin ChurchillDonald SlappeyVaughan Clift<h4>Objective</h4>The Low Molecular Weight Fraction of 5% human serum Albumin (LMWF-5A) is being investigated as a treatment for knee pain from osteoarthritis.<h4>Methods</h4>This was a multicenter randomized, vehicle-controlled, double-blind, parallel study designed to evaluate the safety and efficacy of two doses of an intra-articular injection of LMWF-5A. Patients with symptomatic knee osteoarthritis were randomized 1∶1∶1∶1 to receive a single 4 mL or 10 mL intra-articular knee injection of either LMWF-5A or vehicle control (saline). The primary efficacy endpoint was the difference between treatment groups in the Western Ontario and McMaster Universities (WOMAC) pain change from baseline over 12 weeks. Safety was examined as the incidence and severity of adverse events (AEs).<h4>Results</h4>A total of 329 patients were randomized and received treatment. LMWF-5A resulted in a significant decrease in pain at 12 weeks compared to vehicle control (-0.93 vs -0.72; estimated difference from control: -0.25, p = 0.004); an injection volume effect was not observed (p = 0.64). The effect of LMWF-5A on pain was even more pronounced in patients with severe knee OA (Kellgren Lawrence Grade IV): the estimated difference from control was -0.42 (p = 0.02). Adverse events were generally mild and were similar in patients who received vehicle control (47%) and LMWF-5A (41%).<h4>Conclusions</h4>This clinical trial demonstrated that LMWF-5A is safe and effective at providing relief for the pain of moderate to severe OA of the knee over 12 weeks when administered by intra-articular injection into the knee.<h4>Trial registration</h4>ClinicalTrials.gov NCT01839331.https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0087910&type=printable |
| spellingShingle | David Bar-Or Kristin M Salottolo Holli Loose Matthew J Phillips Brian McGrath Nathan Wei James L Borders John E Ervin Alan Kivitz Mark Hermann Tammi Shlotzhauer Melvin Churchill Donald Slappey Vaughan Clift A randomized clinical trial to evaluate two doses of an intra-articular injection of LMWF-5A in adults with pain due to osteoarthritis of the knee. PLoS ONE |
| title | A randomized clinical trial to evaluate two doses of an intra-articular injection of LMWF-5A in adults with pain due to osteoarthritis of the knee. |
| title_full | A randomized clinical trial to evaluate two doses of an intra-articular injection of LMWF-5A in adults with pain due to osteoarthritis of the knee. |
| title_fullStr | A randomized clinical trial to evaluate two doses of an intra-articular injection of LMWF-5A in adults with pain due to osteoarthritis of the knee. |
| title_full_unstemmed | A randomized clinical trial to evaluate two doses of an intra-articular injection of LMWF-5A in adults with pain due to osteoarthritis of the knee. |
| title_short | A randomized clinical trial to evaluate two doses of an intra-articular injection of LMWF-5A in adults with pain due to osteoarthritis of the knee. |
| title_sort | randomized clinical trial to evaluate two doses of an intra articular injection of lmwf 5a in adults with pain due to osteoarthritis of the knee |
| url | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0087910&type=printable |
| work_keys_str_mv | AT davidbaror arandomizedclinicaltrialtoevaluatetwodosesofanintraarticularinjectionoflmwf5ainadultswithpainduetoosteoarthritisoftheknee AT kristinmsalottolo arandomizedclinicaltrialtoevaluatetwodosesofanintraarticularinjectionoflmwf5ainadultswithpainduetoosteoarthritisoftheknee AT holliloose arandomizedclinicaltrialtoevaluatetwodosesofanintraarticularinjectionoflmwf5ainadultswithpainduetoosteoarthritisoftheknee AT matthewjphillips arandomizedclinicaltrialtoevaluatetwodosesofanintraarticularinjectionoflmwf5ainadultswithpainduetoosteoarthritisoftheknee AT brianmcgrath arandomizedclinicaltrialtoevaluatetwodosesofanintraarticularinjectionoflmwf5ainadultswithpainduetoosteoarthritisoftheknee AT nathanwei arandomizedclinicaltrialtoevaluatetwodosesofanintraarticularinjectionoflmwf5ainadultswithpainduetoosteoarthritisoftheknee AT jameslborders arandomizedclinicaltrialtoevaluatetwodosesofanintraarticularinjectionoflmwf5ainadultswithpainduetoosteoarthritisoftheknee AT johneervin arandomizedclinicaltrialtoevaluatetwodosesofanintraarticularinjectionoflmwf5ainadultswithpainduetoosteoarthritisoftheknee AT alankivitz arandomizedclinicaltrialtoevaluatetwodosesofanintraarticularinjectionoflmwf5ainadultswithpainduetoosteoarthritisoftheknee AT markhermann arandomizedclinicaltrialtoevaluatetwodosesofanintraarticularinjectionoflmwf5ainadultswithpainduetoosteoarthritisoftheknee AT tammishlotzhauer arandomizedclinicaltrialtoevaluatetwodosesofanintraarticularinjectionoflmwf5ainadultswithpainduetoosteoarthritisoftheknee AT melvinchurchill arandomizedclinicaltrialtoevaluatetwodosesofanintraarticularinjectionoflmwf5ainadultswithpainduetoosteoarthritisoftheknee AT donaldslappey arandomizedclinicaltrialtoevaluatetwodosesofanintraarticularinjectionoflmwf5ainadultswithpainduetoosteoarthritisoftheknee AT vaughanclift arandomizedclinicaltrialtoevaluatetwodosesofanintraarticularinjectionoflmwf5ainadultswithpainduetoosteoarthritisoftheknee AT davidbaror randomizedclinicaltrialtoevaluatetwodosesofanintraarticularinjectionoflmwf5ainadultswithpainduetoosteoarthritisoftheknee AT kristinmsalottolo randomizedclinicaltrialtoevaluatetwodosesofanintraarticularinjectionoflmwf5ainadultswithpainduetoosteoarthritisoftheknee AT holliloose randomizedclinicaltrialtoevaluatetwodosesofanintraarticularinjectionoflmwf5ainadultswithpainduetoosteoarthritisoftheknee AT matthewjphillips randomizedclinicaltrialtoevaluatetwodosesofanintraarticularinjectionoflmwf5ainadultswithpainduetoosteoarthritisoftheknee AT brianmcgrath randomizedclinicaltrialtoevaluatetwodosesofanintraarticularinjectionoflmwf5ainadultswithpainduetoosteoarthritisoftheknee AT nathanwei randomizedclinicaltrialtoevaluatetwodosesofanintraarticularinjectionoflmwf5ainadultswithpainduetoosteoarthritisoftheknee AT jameslborders randomizedclinicaltrialtoevaluatetwodosesofanintraarticularinjectionoflmwf5ainadultswithpainduetoosteoarthritisoftheknee AT johneervin randomizedclinicaltrialtoevaluatetwodosesofanintraarticularinjectionoflmwf5ainadultswithpainduetoosteoarthritisoftheknee AT alankivitz randomizedclinicaltrialtoevaluatetwodosesofanintraarticularinjectionoflmwf5ainadultswithpainduetoosteoarthritisoftheknee AT markhermann randomizedclinicaltrialtoevaluatetwodosesofanintraarticularinjectionoflmwf5ainadultswithpainduetoosteoarthritisoftheknee AT tammishlotzhauer randomizedclinicaltrialtoevaluatetwodosesofanintraarticularinjectionoflmwf5ainadultswithpainduetoosteoarthritisoftheknee AT melvinchurchill randomizedclinicaltrialtoevaluatetwodosesofanintraarticularinjectionoflmwf5ainadultswithpainduetoosteoarthritisoftheknee AT donaldslappey randomizedclinicaltrialtoevaluatetwodosesofanintraarticularinjectionoflmwf5ainadultswithpainduetoosteoarthritisoftheknee AT vaughanclift randomizedclinicaltrialtoevaluatetwodosesofanintraarticularinjectionoflmwf5ainadultswithpainduetoosteoarthritisoftheknee |