AzTrials
AzTrials

Low Back PainPhase 2IDN5243inLBPNCT02568826

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

A Phase 2 study testing 3-glycosyl-3-Odemethylthiocolchicine derivative in people with Low Back Pain, run by Indena S.p.A at 1 site in Italy.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Low Back Pain
What is being tested?
3-glycosyl-3-Odemethylthiocolchicine derivative
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteItaly
Study dates
Apr 2016to Mar 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients,
  • 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.

Who cannot join

  • LPB of non-mechanical origin such as neoplasm, infection or inflammatory chronic disorder,
  • 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,
Show all 31Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Istituto di Reumatologia Complesso Integrato Columbus - Policlinico A. Gemelli

    Rome, RM, 00168

Other trials in Italy

About this study

Official title: Tolerability, Safety and Activity of IDN5243, 4 mg Bid Intramuscularly in the Treatment of Low Back Pain. A Prospective, Open Label, Single-center, Uncontrolled Study

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).

Read the detailed description

The purpose of this trial is to evaluate in a Phase 2 A study, the analgesic tolerability, safety and activity of IDN 5243 (3-glycosyl-3-O-demethylthiocolchicine derivative) administered intramuscularly at 4mg b.i.d. for 5 days in subjects with Low Back Pain (LBP).

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
Low Back Pain
Being tested
3-glycosyl-3-Odemethylthiocolchicine derivative
Keywords
Low Back Pain, Muscle relaxant
Medical subject headings
Low Back Pain, Muscle Hypotonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3-glycosyl-3-Odemethylthiocolchicine derivativeDrug

    Also called IDN 5243

    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.

Study groups in NCT02568826
Study groupRoleWhat they receive
IDN 5243ExperimentalIDN 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).
Receives: Drug: 3-glycosyl-3-Odemethylthiocolchicine derivative

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety (vital signs, laboratory evaluations and incidence of adverse events)

    The primary outcome 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.

    Measured: From baseline to day 5

  2. Local tolerability (4-point scale)

    Local tolerability assessed by the patient using a 4-point scale (where 0=none, 1=mild, 2=moderate, and 3=severe) every day during the treatment period and clinically by Investigator.

    Measured: From baseline to day 5

Secondary outcomes (3)

  1. Analgesic activity (spontaneous pain) by Visual Analogue Scale

    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 delta of the Visual Analogue Scale (VAS Scale) score (100 mm) evaluated from baseline to day 5 (Visit V5). The 100 mm VAS score will consider a 0 mm value as NO pain, and 100 mm value as the most SEVERE pain imaginable.

    Measured: From baseline to day 5

  2. Analgesic activity by Hand-To-Floor Distance (HTFD)

    Hand-To-Floor Distance (HTFD) evaluated by Investigator on DAY 1 and 5. HTFD will be measured by the Investigators who will ask the patients to bend forward and try to touch the floor with the fingers; the remaining distance between fingers and ground ("hand-to-floor") will be measured by means of a rule (cm).

    Measured: On day 1 and 5

  3. Quality of Life by SF-36 questionnaire

    The patient will be asked to complete the questionnaire on quality of life (SF-36 questionnaire).

    Measured: From baseline to day 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2015 (estimated)
  2. Study startApr 2016
  3. Primary completionMar 2018
  4. Study completionMar 2018

Why it stopped: No patients enrolled in the study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02568826
Sponsor's protocol ID
XIL02/15
Acronym
IDN5243inLBP
Status last verified
Jul 2025
First submitted
30 Sep 2015
Last updated
22 Jul 2025
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 17909211

  • Mellinghoff H. [Modern muscle relaxants and their clinical application]. Anaesthesist. 1994 Apr;43(4):270-82. doi: 10.1007/s001010050058. German.

    PubMed 8179178

  • 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.

    PubMed 15187636

  • 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.

    PubMed 15082991

  • 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.

    PubMed 16963380

  • 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.

    PubMed 18270354

  • 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.

    PubMed 18524652

  • 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.

    PubMed 22146287

  • 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.

    PubMed 18164449

  • Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.

    PubMed 4139420

  • Scott J, Huskisson EC. Graphic representation of pain. Pain. 1976 Jun;2(2):175-84. No abstract available.

    PubMed 1026900

  • 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.

    PubMed 16000093

  • 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.

    PubMed 16806306

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 3-glycosyl-3-Odemethylthiocolchicine derivative in people with Low Back Pain, run by Indena S.p.A at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety (vital signs, laboratory evaluations and incidence of adverse events) (time frame: From baseline to day 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02568826, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in