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Safety Study of Ibuprofen to Treat Acute Traumatic Spinal Cord Injury

NCT02096913 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-10-30

No results posted yet for this study

Summary

The Ibuprofen - Spinal Cord Injury (SCI) - Safety trial investigates tolerability and feasibility of "small molecule" (Ibuprofen) mediated Rho-inhibition as putative neuroprotective, plasticity-enhancing and neurorestaurative intervention. The primary safety analysis is based on the incidence of severe gastrointestinal bleedings. In addition, the feasibility of recruitment procedure, and oral administration of the compound within the multidisciplinary setting of acute intensive medical care will be explored. Furthermore, the pharmacokinetics of Ibuprofen under the condition of acute motor complete SCI will be investigated. Secondary endpoints will permit preliminary statements about effects on neuropathic pain, spasticity, and neurological function.

Conditions

  • Spinal Cord Injury

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • Else Kröner Fresenius Foundation

    collaborator OTHER

  • Jan M. Schwab, MD, PhD

    lead OTHER

Principal Investigators

  • Andreas Niedeggen, MD · Unfallkrankenhaus Berlin, Treatment Centre for Spinal Cord Injuries, Germany

  • Jan M Schwab, MD, PhD · Charité, Universitätsmedizin Berlin, Spinal Cord Injury Research, Germany

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2017-09-30
Completion
2017-09-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02096913 on ClinicalTrials.gov