Acetaminophen and Ibuprofen With and Without Magnesium and Primary Migraine in Childhood

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Luca Gallelli, University of Cantanzaro
ClinicalTrials.gov Identifier:
NCT01756209
First received: December 19, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

Aim: The purpose of this study was to evaluate both the effects of ibuprofen and/or acetaminophen for the acute treatment of primary migraine in children in or out prophylactic treatment with magnesium.

Methods: The study had been approved by the Researchers Ethics Committee of the "Pugliese-Ciaccio" Hospital (protocol number 720/2010; EUDRACT NUMBER 2012-005737-36) and the children ranging from the ages of 5 to 18 years with at least four attack/month of primary migraine were enrolled. A Visual Analogical Scale was used to evaluate pain intensity at the moment of admission to the study (start of the study) and every month up to 18 months later (end of the study).


Condition
Migraine

Study Type: Observational [Patient Registry]
Study Design: Time Perspective: Prospective
Target Follow-Up Duration: 18 Months
Official Title: The Effects of Acetaminophen and Ibuprofen With and Without Magnesium in the Treatment of Primary Migraine in Childhood

Resource links provided by NLM:


Further study details as provided by University of Cantanzaro:

Primary Outcome Measures:
  • pain-relief [ Time Frame: 3 and 18 months ] [ Designated as safety issue: No ]
    The primary endpoint was when pain-relief took place and pain intensity differences from baseline (0 hour) to 3 hours after drug treatment. This measurement was defined as the AUC for the sum of the 2 measurements (pain relief and pain intensity difference) at each time point from 0 to 3 hours.


Biospecimen Retention:   Samples With DNA

whole blood


Enrollment: 160
Study Start Date: January 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

we peformed a single blind study in outpatient children enrolled at the Pediatric Unit-Pugliese Ciaccio Hospital in Catanzaro

Criteria

Inclusion Criteria:

Children with migraine without aura (MoA) of both sexes aged from 5 to 18 years, with at least four attacks /month, were eligible for the study. MoA was diagnosed according to the criteria for pediatric age of the International Classification of Headache Disorders (IHS-2)

Exclusion Criteria:

Exclusion criteria were the following: mental retardation (IQ <70), genetic syndromes (e.g., Down syndrome, Prader-Willi syndrome, fragile X syndrome), hypothyroidism, psychiatric disorders (i.e.: schizophrenia, mood disorders, ADHD), neuromuscular disorders, epilepsy, obesity (BMI>95 percentiles), liver or renal diseases, gastrointestinal disorders such as peptic or duodenal ulcer, dyspepsia, or heartburn; hypersensitivity to medication studies.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01756209

Locations
Italy
Pugliese Ciaccio Hospital
Catanzaro, Italy, 88100
Sponsors and Collaborators
University of Cantanzaro
  More Information

No publications provided

Responsible Party: Luca Gallelli, MD, PhD, University of Cantanzaro
ClinicalTrials.gov Identifier: NCT01756209     History of Changes
Other Study ID Numbers: Migraine2010
Study First Received: December 19, 2012
Last Updated: December 19, 2012
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics

ClinicalTrials.gov processed this record on September 16, 2014