| Home | Search | Study Topics | Glossary |
|
|
|
 |
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Descriptive Information Fields | |||||||||
| Brief Title † | Trial on Metoclopramide and Ketoprofen in Acute Migraine of Childhood | ||||||||
| Official Title † | Randomized Controlled Trial on the Effectiveness of Metoclopramide Alone or in Combination With Ketoprofen in Acute Migraine of Child | ||||||||
| Brief Summary | This is a Randomized double blind trial with the aim to estimate the effectiveness of 3 therapeutic regimes per os on migraine pain:
Intensity of pain will be measured with linear 1-10 scale or analogic McGrath type scale every 20 min. The main objective is the evaluation of healing times from pain in the 3 groups |
||||||||
| Detailed Description | |||||||||
| Study Phase | Phase III | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | evaluation of healing times from pain in the 3 groups [ Time Frame: 2 hours ] | ||||||||
| Secondary Outcome Measure † | evaluation of failures and necessity of rescue treatment after 2 hours and after 24 hours [ Time Frame: 24 hours ] | ||||||||
| Condition † | Child Migraine |
||||||||
| Intervention † | Drug: metoclopramide and ketoprofen Drug: metoclopramide and placebo Drug: ketoprofen and placebo |
||||||||
| MEDLINE PMIDs | |||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Not yet recruiting | ||||||||
| Enrollment † | 120 | ||||||||
| Start Date † | January 2008 | ||||||||
| Completion Date | January 2010 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 6 Years to 17 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
|
||||||||
| Location Countries † | Italy | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00557544 | ||||||||
| Organization ID | rc 32/07 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | IRCCS Burlo Garofolo | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
|
||||||||
| Information Provided By | IRCCS Burlo Garofolo | ||||||||
| Verification Date | November 2007 | ||||||||
| First Received Date † | November 13, 2007 | ||||||||
| Last Updated Date | November 13, 2007 | ||||||||
|
