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A preference trial with naratriptan 2,5 mg and paracetamol 1000 mg in migraine patients in the general practice.


- candidate number0
- NTR NumberNTR34
- ISRCTNISRCTN57387771
- Date ISRCTN created16-mei-2005
- date ISRCTN requested12-apr-2005
- Date Registered NTR6-dec-2004
- Secondary IDsN/A 
- Public TitleA preference trial with naratriptan 2,5 mg and paracetamol 1000 mg in migraine patients in the general practice.
- Scientific TitleA preference trial with naratriptan 2,5 mg and paracetamol 1000 mg in migraine patients in the general practice.
- ACRONYMN/A
- hypothesisPatients prefer naratriptan over paracetamol 1000 mg for the acute treatment of migraine attacks.
- Healt Condition(s) or Problem(s) studiedMigraine
- Inclusion criteria1. The subject is older than 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 day 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 ischemic 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 who currently abuse alcohol, analgesics or psychotropic drugs;
4. Subjects who have any severe concurrent medical condition which may affect the interpretation in a clinical trial;
5. Subjects with a history of basilar, hemiplegic or ophtalmoplegic migraine;
6. Subjects with impaired hepatic or renal function;
7. Subjects who have a known or suspected hypersensitivity to, intolerance of, or contraindications to any component of the study medication;
8. Females who are pregnant or breastfeeding, and females of childbearing potential who are not using a medically acceptable form of contraception;
9. 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;
10. Subjects with a history of hypertension or a current bloodpressure above 160/95 (measured 3 times).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2005
- planned closingdate31-dec-2005
- Target number of participants40
- 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. Changes in quality of life;
2. Pain free rate at 2 hours postdose.
- 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), Department of Neurology
- Funding
(Source(s) of Monetary or Material Support)
GlaxoSmithKline, Leiden University Medical Center (LUMC)
- PublicationsN/A
- Brief summaryTraditional efficacy outcome measures in migraine trials are not sensitive enough to detect clinically relevant differences between two active agents. A promising novel method of comparing migraine treatments is a patient preference study, in which the patients are asked to use both treatments and then assign preference to one of the treatments. We would like to test the concept of patient preference as the primary endpoint in a randomised double blind cross-over study, comparing an analgesic with a triptan for the acute treatment of 3 migraine attacks in patients from the general population, who have not used a triptan or ergot before.


Objective:
to demonstrate patient preference for naratriptan 2.5 mg to paracetamol 1000 mg.


Design:
A randomised, double blind, double-dummy, cross-over study. Fourty subjects will be randomised to either naratriptan or paracetamol 1000 mg with a cross-over after 3 attacks. Subjects rate their satisfaction with treatment after each attack. Preference is evaluated after the second treatment period.
- Main changes (audit trail)
- RECORD5-jul-2005 - 9-okt-2008


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