Condition category
Nervous System Diseases
Date applied
16/05/2005
Date assigned
16/05/2005
Last edited
04/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.msd.nl/

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

Publication citations

Additional files

Editorial Notes