Safety Study of Ibuprofen to Treat Acute Traumatic Spinal Cord Injury

PHASE1CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

June 30, 2013

Primary Completion Date

September 30, 2017

Study Completion Date

September 30, 2017

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."

Trial Locations (1)

12683

Unfallkrankenhaus Berlin, Treatment Centre for Spinal Cord Injuries, Warener Straße 7, Berlin

All Listed Sponsors
collaborator

Else Kröner Fresenius Foundation

OTHER

lead

Jan M. Schwab, MD, PhD

OTHER

NCT02096913 - Safety Study of Ibuprofen to Treat Acute Traumatic Spinal Cord Injury | Biotech Hunter | Biotech Hunter