Contact information
Type
Scientific
Primary contact
Dr N.J. Wiendels
ORCID ID
Contact details
Leiden University Medical Center
Department of Neurology
K5Q-106
P.O. Box 9600
Leiden
2300 RC
Netherlands
+31 (0)71 526 1730
N.J.Wiendels@lumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR33
Study information
Scientific title
Acronym
Study hypothesis
Patients prefer rizatriptan over ibuprofen for the acute treatment of migraine.
Ethics approval
Ethics approval received from the local Medical Ethics Committee.
Study design
Randomised, double blind, double dummy, crossover study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Migraine
Intervention
Thirty-five triptan naive patients treat three attacks within each crossover period with either:
1. Rizatriptan 10 mg
2. Ibuprofen 400 mg
Preference is measured after the second period on a 10 cm scale.
Intervention type
Drug
Phase
Not Specified
Drug names
Rizatriptan, ibuprofen
Primary outcome measures
Direction and strength of patient preference on a 10 cm scale ranging from -5 (strong preference for treatment 1) to +5 (strong preference for treatment 2) where 0 indicates no preference.
Secondary outcome measures
1. Pain free rate at 2 hours postdose
2. Migraine disability assessment (MIDAS) score at visit 1
Overall trial start date
23/03/2005
Overall trial end date
09/11/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. At least 18 years of age at visit 1
2. Current history of migraine with or without aura according to the International Headache Society (IHS) criteria
3. Experienced an average of at least one migraine attack per month for six months prior to entry to the study
4. Naïve to the use of 5HT1 agonists and ergotamine
5. Willing and able to understand and complete questionnaires
6. Willing and able to give informed consent prior to entry into the study
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
35
Participant exclusion criteria
1. 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. A history of cerebrovascular accident (CVA) or transient ischaemic attack (TIA)
3. A history of hypertension or a current blood pressure above 160/95 mmHg (measured three times)
4. A history of basilar, hemiplegic or ophtalmoplegic migraine
5. Impaired hepatic or renal function
6. A history of gastrointestinal disease
7. A history of asthma
8. Have a known or suspected hypersensitivity to, intolerance of, or contraindications to any component of the study medication
9. Currently use propanolol as a prophylactic agent
10. Currently use monoamine oxidase (MAO) inhibitors
11. Currently abuse alcohol, analgesics or psychotropic drugs
12. A history of hypertension
13. 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. Have participated in a clinical trial within the previous month or are currently participating in any other clinical research study or clinical trial
Recruitment start date
23/03/2005
Recruitment end date
09/11/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
Leiden University Medical Center
Leiden
2300 RC
Netherlands
Sponsor information
Organisation
Merck Sharp and Dohme BV (MSD) (The Netherlands)
Sponsor details
P.O. Box 581
Haarlem
2003 PC
Netherlands
+31 (0)23 515 3153
msdbvnl@merck.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Merck Sharp and Dohme BV (MSD) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Booth Healthcare International (The Netherlands) - now Reckittbenckiser
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary