Efficacy and Safety of Metamizole Versus Placebo as Antithermic Therapy in the Acute Phase of Ischemic Stroke

Phase 4

Terminated

• Conditions: Stroke
• Interventions: Drug: Metamizole; Drug: Placebo

• Registration Number: NCT02184260
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Clinical efficacy and safety of Metamizole 2 g i.v. versus placebo, as antithermic therapy in the acute phase of ischemic stroke.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-12
• Primary Completion: 2002-05
• Status Verified: 2014-07
• Study First Submitted: 2014-07-08
• Study First Submitted QC: 2014-07-08
• Study First Posted: 2014-07-09
• Last Update Submitted: 2014-07-09
• Last Update Posted: 2014-07-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• Age over 18 years
• Hemispherical cerebral infarction with moderate (SSS = 30-44 points) or severe (SSS < 30 points) deficit at the time of inclusion. However, only patients with a score between 15 and 44 points on the SSS scale will be included
• Tympanic temperature between 37 and 38 degrees Celsius. The relationship between tympanic and body temperature is as follows: tympanic temperature = body temperature + 0.3 degrees Celsius
• Onset of cerebral infarction symptoms within the last 24 hours. When the time of onset of symptoms is unknown (e.g. ictus occurred while sleeping) the last time when the patient was asymptomatic will be considered as time of onset
• Normal cerebral CT scan or with signs of cerebral infarction
• Patient's written or orally witnessed informed consent in accordance with local legislation, guidelines of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH)-GCP

Exclusion Criteria

• Patients with a history of granulocytopenia, thrombocytopenia or aplastic blood diseases of any etiology. Known hypersensitivity to salicylates, pyrazolones and other nonsteroidal antiinflammatory drugs (NSAIDs). NSAID-induced bronchial asthma
• Patients with a history indicating a life expectancy less than 30 days or patients whom the investigator thinks that it will not be possible to follow for entire 30 days
• Non-cooperative
• Patients with neurological sequelae of a previous stroke
• Cerebral hemorrhage
• Pregnancy, lactation
• Participation in another clinical trial
• Intake of acetylsalicylic acid (ASA) > 300 mg per day, paracetamol or NSAIDs during the 24 hours prior to administration of the study medication
• Seizures at the start of the stroke

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metamizole	Metamizole	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Assessment of the functional outcome according to the Scandinavian Stroke Scale (SSS)	after 30 days

Secondary Outcome Measures

Name	Time	Method
Effect on the activities of daily living assessed on Barthel Index	after 30 days
Duration of hospital stay	up to 30 days
Number of patients with score of SSS < 30 points	after 30 days
Clinical impression assessed on the Modified Rankin Scale	after 30 days
Number of patients requiring rescue therapy	up to 30 days
Assessment of functional outcome according to SSS	Baseline, after 3 and 7 days
Percentage of mortality	after 30 days
Assessment of tympanic temperature	up to 3 days after start of treatment
Number of patients with adverse events	up to 30 days