No registrations found.
ID
Source
Brief title
Intervention
Outcome measures
Primary outcome
Direction 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 outcome
1. Painfree rate at 2 hours postdose;
2. MIDAS score at visit 1.
Background summary
Objective:
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.
Study objective
Patients prefer rizatriptan over ibuprofen for the acute treatment of migraine.
Study design
N/A
Intervention
Our clinics were asked to treat three attacks with each medication and then fill out a preference trial (cross-over study).
P.O. Box 9600
N.J. Wiendels
Leiden 2300 RC
The Netherlands
+31 (0)71 5261730
N.J.Wiendels@lumc.nl
P.O. Box 9600
N.J. Wiendels
Leiden 2300 RC
The Netherlands
+31 (0)71 5261730
N.J.Wiendels@lumc.nl
Inclusion criteria
1. 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 naïve 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 criteria
1. 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9 |
| NTR-old | NTR33 |
| Other | : N/A |
| ISRCTN | ISRCTN18216584 |