Tolerability, Safety and Activity of a Muscle Relaxant Molecule IDN5243 in Patients With Low Back Pain
NCT ID: NCT02568826
Last Updated: 2025-07-22
Study Results
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Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2016-04-30
2018-03-31
Brief Summary
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Detailed Description
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IDN 5243 (3-glycosyl-3-O-demethylthiocolchicine derivative) is a new muscle relaxant molecule prepared by synthesis from D-xylose and 3-O-demethylthiocolchicine.
The primary outcomes of the study will be to evaluate the systemic safety (vital signs, laboratory evaluations and incidence of adverse events) of the study drug assessed by Investigator taking into consideration the change from baseline to DAY 5, the local tolerability assessed by the patient every day during the treatment period and by Investigator.
The secondary objectives of the study will be to evaluate the analgesic activity of the study drug. Analgesic activity will be evaluated with scoring spontaneous pain. In particular, the secondary outcome of the trial will be the change of the Visual Analogue Scale (VAS Scale) score (100 mm) evaluated at baseline and at DAY 5 (Visit V5). Moreover, the evaluation of secondary parameters for the analgesic activity and changes on quality of life will be assessed.
Patients will perform a total of 6 visits: 5 visits during the treatment duration (day 1 - day 5) and a Follow-up visit (day 12) will be performed after 7 days from the end of treatment (± 2 days in the event that the visit will occur on Sunday).
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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IDN 5243
IDN 5243 is a new 3-glycosyl-3-Odemethylthiocolchicine derivative endowed with muscle-relaxant, anti-inflammatory and analgesic activities for intramuscular administration in 4 mg/mL vials. It will be administered twice daily for 5 consecutive days with the first administration in the morning (8.00-10.00 AM) and the second in the evening (6.00-8.00 PM).
3-glycosyl-3-Odemethylthiocolchicine derivative
IDN 5243 is a new muscle relaxant molecule. This molecule has showed significant anti-inflammatory activity by intraperitoneal route at 10 mg/kg in both carrageenan induced oedema and granuloma tests. IDN 5243 is a new 3-glycosyl-3-Odemethylthiocolchicine derivative endowed with muscle-relaxant, anti-inflammatory and analgesic activities. The primary packaging of test formulation will be a glass vial containing a solution of IDN 5243, 4 mg/ 1 mL. The secondary package will correspond to the patient's kit and will be a box containing ten (10) vials. The box label will be provided with a tear-off label.
Interventions
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3-glycosyl-3-Odemethylthiocolchicine derivative
IDN 5243 is a new muscle relaxant molecule. This molecule has showed significant anti-inflammatory activity by intraperitoneal route at 10 mg/kg in both carrageenan induced oedema and granuloma tests. IDN 5243 is a new 3-glycosyl-3-Odemethylthiocolchicine derivative endowed with muscle-relaxant, anti-inflammatory and analgesic activities. The primary packaging of test formulation will be a glass vial containing a solution of IDN 5243, 4 mg/ 1 mL. The secondary package will correspond to the patient's kit and will be a box containing ten (10) vials. The box label will be provided with a tear-off label.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18-70 years old inclusive,
* Signed Informed consent obtained prior the inclusion in the trial,
* A diagnosis of LBP equal to or greater than 50 mm on VAS with severe or moderate lumbar muscle spasm naïve or in relapsing condition,
* Patients must have a medical history, physical and neurological examinations that support a clinical diagnosis of acute LBP that is felt down to the lower leg below the knee with the onset no longer than 30 days before Visit 1,
* Patients must be appropriate candidates for treatment with study medication in the Investigator's clinical judgment,
* Patients must be able to appropriately verbalize pain characteristics and to complete all protocol required measurements/assessments without assistance,
* Patients must be medically stable on the basis of physical examination, medical history, vital signs, and clinical laboratory tests performed at screening.
Exclusion Criteria
* Serum creatinine level \> 1.7 mg/dL or Urea \> 17 mmol/l,
* Severe to mild hepatic dysfunction,
* Abnormal blood count,
* Ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients,
* History of anaphylaxis to drugs or allergic reactions in particular, history of hypersensitivity reactions (e.g. bronchospasm, rhinitis, urticaria) to drugs including to paracetamol,
* Patients with diabetic neuropathy, post-herpetic neuralgia, osteoarthritis pain, fibromyalgia,
* History of psychosis (e.g. schizophrenia or psychotic depression) or major depression (requiring treatment), diagnosis including dementia, anxiety, mental retardation; multiple sclerosis, Parkinson's Disease, Restless Legs Syndrome,
* Significant kidney or liver disease,
* History of gastrointestinal disorders,
* Blood coagulation disorders,
* Skin conditions affecting the site of application (e.g. eczema, weeping dermatitis),
* Use of paracetamol and/or NSAIDs (NonSteroidal AntiInflammatory Drugs) within 24 h before inclusion,
* Use of topical medications applied to the painful region within 2 days before the inclusion; use of opioids within 7 days before the inclusion,
* Use of corticosteroid drugs by any route of administration within 30 days before the inclusion,
* Use of myorelaxant drugs within 3 days before the inclusion,
* Pregnant or lactating women, or women of childbearing age not using a reliable method of contraception, or women of not child-bearing potential if not permanently sterilised or if not in post-menopausal status from at least two years,
* Males not to agree to use a reliable method of contraception during the study and the follow up period, if sexually active with a female of child-bearing potential,
* History of back (cervical, thoracic or lumbosacral) pain as 50% of the time in the 1 year prior to the first visit,
* History of any LBP episode, with the exception of the current acute LBP episode, within 3 months prior to the first visit that was greater than mild in pain intensity, or was associated with disability (e.g., loss of time from work, family, or activities of daily living), or necessitated the use of an opioid (narcotic) analgesic including tramadol,
* Medical history or physical examination results that suggest the acute LBP or any of the neurological symptoms or signs are caused by a serious medical condition (e.g., fever, chills, unexplained weight loss, bowel or urinary bladder dysfunction or incontinence, bilateral leg weakness, progressive weakness, paralysis),
* There is a high probability for surgical intervention for the back pain during the projected time on the study or that there will be an increase in the severity of the leg pain or deficits,
* Had either a surgical procedure involving the spine or intervertebral discs in the lower back region within 1 year prior to Visit 1 or had \>1 surgical procedure(s) involving the spine or intervertebral discs in the lower back region,
* Has any painful condition that could interfere with the study assessments or with the patient's ability to differentiate the pain associated with the acute LBP episode from pain associated with another condition,
* History of epilepsy or recurrent seizures,
* Unable or unwilling to discontinue all prohibited medications at the time of randomization and during the time of their participation in the study,
* Known or suspected history of alcohol or drug abuse based on medical history, physical examination, urine drug screening, or the Investigator's clinical judgment,
* Have filed or plan to file a worker's compensation claim for any issue related to the current acute LBP episode,
* Currently involved in litigation or plan to seek legal recourse for any issue related to their acute LBP,
* Known allergies, hypersensitivity, or intolerance to the study drug or any excipients used in their manufacture,
* Had previously been enrolled in a muscle relaxant clinical study within 30 days before the inclusion.
18 Years
70 Years
ALL
No
Sponsors
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Sintesi Research Srl
INDUSTRY
Indena S.p.A
INDUSTRY
Responsible Party
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Principal Investigators
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Gianfranco Ferraccioli, MD
Role: PRINCIPAL_INVESTIGATOR
Istituto di Reumatologia Complesso Integrato Columbus - Policlinico Gemelli Roma
Locations
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Istituto di Reumatologia Complesso Integrato Columbus - Policlinico A. Gemelli
Rome, RM, Italy
Countries
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References
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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.
Mellinghoff H. [Modern muscle relaxants and their clinical application]. Anaesthesist. 1994 Apr;43(4):270-82. doi: 10.1007/s001010050058. German.
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.
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.
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.
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.
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.
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.
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.
Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.
Scott J, Huskisson EC. Graphic representation of pain. Pain. 1976 Jun;2(2):175-84. No abstract available.
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.
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.
Other Identifiers
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XIL02/15
Identifier Type: -
Identifier Source: org_study_id
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