Tolerability, Safety and Activity of a Muscle Relaxant Molecule IDN5243 in Patients With Low Back Pain

Summary

This is a prospective cohort study, open-label, uncontrolled proof of concept trial. The trial objective is to evaluate the analgesic tolerability, safety and activity of IDN 5243 (3-glycosyl-3-O-demethylthiocolchicine derivative)administered intramuscularly at 4 mg b.i.d. for 5 days in the morning (8.00-10.00 AM) and in the evening (6.00-8.00 PM) in subjects with Low Back Pain (LBP).

Timeline

Start

2016-04

Primary completion

2018-03

Completion

2018-03

Outcome

Outcome not reported

Stopped (Enrollment): “No patients enrolled in the study.”

Publications

• Background Chou R, Huffman LH; American Pain Society; American College of Physicians. Medications for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Ann Intern Med. 2007 Oct 2;147(7):505-14. doi: 10.7326/0003-4819-147-7-200710020-00008.
• Background Mellinghoff H. [Modern muscle relaxants and their clinical application]. Anaesthesist. 1994 Apr;43(4):270-82. doi: 10.1007/s001010050058. German.
• Background Bernstein E, Carey TS, Garrett JM. The use of muscle relaxant medications in acute low back pain. Spine (Phila Pa 1976). 2004 Jun 15;29(12):1346-51. doi: 10.1097/01.brs.0000128258.49781.74.
• Background Dillon C, Paulose-Ram R, Hirsch R, Gu Q. Skeletal muscle relaxant use in the United States: data from the Third National Health and Nutrition Examination Survey (NHANES III). Spine (Phila Pa 1976). 2004 Apr 15;29(8):892-6. doi: 10.1097/00007632-200404150-00014.
• Background Malanga GA, Dennis RL. Use of medications in the treatment of acute low back pain. Clin Occup Environ Med. 2006;5(3):643-53, vii. doi: 10.1016/j.coem.2006.03.002.
• Background Martin BI, Deyo RA, Mirza SK, Turner JA, Comstock BA, Hollingworth W, Sullivan SD. Expenditures and health status among adults with back and neck problems. JAMA. 2008 Feb 13;299(6):656-64. doi: 10.1001/jama.299.6.656.
• Background Wenig CM, Schmidt CO, Kohlmann T, Schweikert B. Costs of back pain in Germany. Eur J Pain. 2009 Mar;13(3):280-6. doi: 10.1016/j.ejpain.2008.04.005. Epub 2008 Jun 3.
• Background Gore M, Sadosky A, Stacey BR, Tai KS, Leslie D. The burden of chronic low back pain: clinical comorbidities, treatment patterns, and health care costs in usual care settings. Spine (Phila Pa 1976). 2012 May 15;37(11):E668-77. doi: 10.1097/BRS.0b013e318241e5de.
• Background Dagenais S, Caro J, Haldeman S. A systematic review of low back pain cost of illness studies in the United States and internationally. Spine J. 2008 Jan-Feb;8(1):8-20. doi: 10.1016/j.spinee.2007.10.005.
• Background Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.
• Background Scott J, Huskisson EC. Graphic representation of pain. Pain. 1976 Jun;2(2):175-84. No abstract available.
• Background Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005 Aug;14(7):798-804. doi: 10.1111/j.1365-2702.2005.01121.x.
• Background Carta M, Murru L, Botta P, Talani G, Sechi G, De Riu P, Sanna E, Biggio G. The muscle relaxant thiocolchicoside is an antagonist of GABAA receptor function in the central nervous system. Neuropharmacology. 2006 Sep;51(4):805-15. doi: 10.1016/j.neuropharm.2006.05.023. Epub 2006 Jun 30.

Drugs

Indications

No indication recorded.