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

Stroke Clinical Trial

— ATIS  

Official title:

A Randomized, Multicentre, Double-blind Clinical Trial of Metamizole 2 g /8 h, I.V. Ampoules, Versus Placebo Each 8 h, I.V. Ampoules, Administered During 3 Days Consecutively as Antithermic Therapy in the Acute Phase of Ischemic Stroke. A 30-day Study. (ATIS Study)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02184260
• Other study ID #: 1093.15
• Status: Terminated
• Phase: Phase 4
• First received: July 8, 2014
• Last updated: July 9, 2014
• Start date: December 1998

Study information

• Verified date: July 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 58
• Est. primary completion date: May 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• Metamizole

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the functional outcome according to the Scandinavian Stroke Scale (SSS)		after 30 days	No
Secondary	Assessment of functional outcome according to SSS		Baseline, after 3 and 7 days	No
Secondary	Number of patients with score of SSS < 30 points		after 30 days	No
Secondary	Clinical impression assessed on the Modified Rankin Scale		after 30 days	No
Secondary	Effect on the activities of daily living assessed on Barthel Index		after 30 days	No
Secondary	Number of patients requiring rescue therapy		up to 30 days	No
Secondary	Duration of hospital stay		up to 30 days	No
Secondary	Assessment of tympanic temperature		up to 3 days after start of treatment	No
Secondary	Percentage of mortality		after 30 days	No
Secondary	Number of patients with adverse events		up to 30 days	No

External Links

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