Safety Study of Ibuprofen to Treat Acute Traumatic Spinal Cord Injury
NCT ID: NCT02096913
Last Updated: 2017-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2013-06-30
2017-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dolormin® extra (Ibuprofen) 4 weeks
Dolormin® extra (Ibuprofen)
Ibuprofen Tablets (as lysine-salt) 2400mg/d (400mg 2-2-2) applied orally for 4 weeks (Arm I; n=6).
In order to reduce the risk of damage to the gastrointestinal mucosa Pantoprazole is applied as concomitant medication in a dosage 40mg/d during the treatment period.
Dolormin® extra (Ibuprofen) 12 weeks
Dolormin® extra (Ibuprofen)
Ibuprofen Tablets (as lysine-salt) 2400mg/d (400mg 2-2-2) applied orally for 12 weeks (Arm II, n=6).
In order to reduce the risk of damage to the gastrointestinal mucosa Pantoprazole is applied as concomitant medication in a dosage 40mg/d during the first 4 weeks of treatment and may be reduced to 20mg/d during the following treatment period after individual risk-benefit assessment.
Interventions
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Dolormin® extra (Ibuprofen)
Ibuprofen Tablets (as lysine-salt) 2400mg/d (400mg 2-2-2) applied orally for 4 weeks (Arm I; n=6).
In order to reduce the risk of damage to the gastrointestinal mucosa Pantoprazole is applied as concomitant medication in a dosage 40mg/d during the treatment period.
Dolormin® extra (Ibuprofen)
Ibuprofen Tablets (as lysine-salt) 2400mg/d (400mg 2-2-2) applied orally for 12 weeks (Arm II, n=6).
In order to reduce the risk of damage to the gastrointestinal mucosa Pantoprazole is applied as concomitant medication in a dosage 40mg/d during the first 4 weeks of treatment and may be reduced to 20mg/d during the following treatment period after individual risk-benefit assessment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Time frame of 4-21 days post-trauma
* Motor complete injury AIS A and B
* Neurological level of the lesion C4-T4
* No participation in a different clinical trial according to German Pharmaceuticals Act (AMG) 1 month before and during participation in the current trial
* The patient has been informed and his/her written consent has been obtained
* Age: 18 to 65 years
* For women of reproductive age: Negative pregnancy test and highly effective contraception (defined as Pearl Index \< 1) or sexual abstinence during participation in the trial
Exclusion Criteria
* Penetrating spinal cord injury
* Accompanying traumatic brain injury (TBI) with visible structural lesions including intracranial hemorrhage on diagnostic imagesSigni
* Significant accompanying injury to the peripheral nervous system, particularly plexus lesions
* Acute or chronic systemic diseases accompanied by neurological deficits or that have caused permanent neurological deficits which may overlay or hinder the registration of sensomotor functions (e.g. multiple sclerosis, Guillain-Barré syndrome, HIV infection, Lues etc.)
* Malignant neoplasms, except if these are in complete remission.
* Mental diseases or dementia which, in the investigator's opinion, limit the patient's cooperation in respect of the intake of the study medication and/or significantly hinder the registration of follow-up parameters
* Hemophilia
* History of myocardial infarction or stroke
* Current and persistent misuse of illegal drugs or alcohol
* Hypothermia below 35 C°
* Pregnancy and lactation
* All further contraindications to the study medication, including other ingredients of the pharmaceutical form according to the Summary of Product Characteristics (SPC)
* Known hypersensitivity to the active substance contained in the concomitant medication Pantoprazole or one of the components of the drug.
* Intake of Ibuprofen or intake of other active substances from the group of Nonsteroidal Anti-inflammatory Drugs (NSAIDs; e.g., Diclofenac, Indometacin) or the intake of NSAIDs in maximum recommended daily doses during one week prior to enrolment in the trial
* Simultaneous intake of salicylates, particularly acetylsalicylic acid
* Simultaneous intake of oral anticoagulants
* Simultaneous intake of systemic glucocorticoids
* Unwilling to consent to storage and transfer of pseudonymized medical data for the purpose of the clinical trial
* Admitted to an institution by a court or official order (pursuant to AMG §40 (1) 4)
18 Years
65 Years
ALL
No
Sponsors
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Else Kröner Fresenius Foundation
OTHER
Jan M. Schwab, MD, PhD
OTHER
Responsible Party
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Jan M. Schwab, MD, PhD
Prof. Dr. Dr.
Principal Investigators
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Andreas Niedeggen, MD
Role: PRINCIPAL_INVESTIGATOR
Unfallkrankenhaus Berlin, Treatment Centre for Spinal Cord Injuries, Germany
Jan M Schwab, MD, PhD
Role: STUDY_DIRECTOR
Charité, Universitätsmedizin Berlin, Spinal Cord Injury Research, Germany
Locations
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Unfallkrankenhaus Berlin, Treatment Centre for Spinal Cord Injuries, Warener Straße 7
Berlin, , Germany
Countries
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References
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Kopp MA, Liebscher T, Watzlawick R, Martus P, Laufer S, Blex C, Schindler R, Jungehulsing GJ, Knuppel S, Kreutztrager M, Ekkernkamp A, Dirnagl U, Strittmatter SM, Niedeggen A, Schwab JM. SCISSOR-Spinal Cord Injury Study on Small molecule-derived Rho inhibition: a clinical study protocol. BMJ Open. 2016 Jul 26;6(7):e010651. doi: 10.1136/bmjopen-2015-010651.
Other Identifiers
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2011-000584-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
Ibuprofen-SCI-Safety
Identifier Type: -
Identifier Source: org_study_id