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A preference trial with rizatriptan 10 mg and ibuprofen 400 mg in migraine patients in the general practice.


- candidate number0
- NTR NumberNTR33
- ISRCTNISRCTN18216584
- Date ISRCTN created16-mei-2005
- date ISRCTN requested12-apr-2005
- Date Registered NTR6-dec-2004
- Secondary IDsN/A 
- Public TitleA preference trial with rizatriptan 10 mg and ibuprofen 400 mg in migraine patients in the general practice.
- Scientific TitleA preference trial with rizatriptan 10 mg and ibuprofen 400 mg in migraine patients in the general practice.
- ACRONYMN/A
- hypothesisPatients prefer rizatriptan over ibuprofen for the acute treatment of migraine.
- Healt Condition(s) or Problem(s) studiedMigraine
- Inclusion criteria1. The subject is at least 18 years of age at visit 1;
2. The subject has a current history of migraine with or without aura according to the IHS criteria;
3. The subject has experienced an average of at least one migraine attack per month for 6 months prior to entry to the study;
4. The subject is na´ve to the use of 5HT1 agonists and ergotamine;
5. The subject is willing and able to understand and complete questionnaires;
6. The subject is willing and able to give informed consent prior to entry into the study.
- Exclusion criteria1. Subjects with a history suggestive of ischaemic heart disease (IHD), (e.g. angina pectoris) or any atherosclerotic disease which places them at increased risk of coronary ischaemia;
2. Subjects with a history of cerebrovascular accident (CVA) or transient ischaemic attack (TIA);
3. Subjects with a history of hypertension or a current blood pressure above 160/95 (measured 3 times);
4. Subjects with a history of basilar, hemiplegic or ophtalmoplegic migraine;
5. Subjects with impaired hepatic or renal function;
6. Subjects with a history of gastrointestinal disease;
7. Subjects with a history of asthma;
8. Subjects who have a known or suspected hypersensitivity to, intolerance of, or contraindications to any component of the study medication;
9. Subjects who currently use propanolol as a prophylactic agent;
10. Subjects who currently use MAO-inhibitors;
11. Subjects who currently abuse alcohol, analgesics or psychotropic drugs;
12. Subjects with a history of hypertension;
13. Subjects who have any severe concurrent medical condition, which may affect the interpretation in a clinical trial;
14. Females who are pregnant or breastfeeding, and females of childbearing potential who are not using a medically acceptable form of contraception;
15. Subjects who have participated in a clinical trial within the previous month or are currently participating in any other clinical research study or clinical trial.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 23-mrt-2005
- planned closingdate9-nov-2006
- Target number of participants35
- InterventionsOur clinics were asked to treat three attacks with each medication and then fill out a preference trial (cross-over study).
- Primary outcomeDirection and strength of patient preference on a 10 cm scale ranging from -5 (strong preference for treatment A) to +5 (strong preference for treatment B) where 0 indicates no preference.
- Secondary outcome1. Painfree rate at 2 hours postdose;
2. MIDAS score at visit 1.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD. N.J. Wiendels
- CONTACT for SCIENTIFIC QUERIESMD. N.J. Wiendels
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Merck Sharp & Dohme BV (MSD), Booth Healthcare International (now Reckittbenckiser)
- PublicationsN/A
- Brief summaryObjective:
to compare patient preference between rizatriptan 10 mg and ibuprofen 400 mg. Methods: a randomised, double blind, double dummy, crossover study. Thirty-five triptan naieve patients treat 3 attacks within each crossover period. Preference is measured after the second period on a 10 cm scale, ankered by -5 (preference for treatment A) and +5 (preference for treatment B), 0 indicates no preference.
- Main changes (audit trail)
- RECORD5-jul-2005 - 9-sep-2009


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