A preference trial with rizatriptan 10 mg and ibuprofen 400 mg in migraine patients in the general practice
| ISRCTN | ISRCTN18216584 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18216584 |
| Secondary identifying numbers | NTR33 |
- Submission date
- 16/05/2005
- Registration date
- 16/05/2005
- Last edited
- 04/03/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr N.J. Wiendels
Scientific
Scientific
Leiden University Medical Center
Department of Neurology, K5Q-106
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Phone | +31 (0)71 526 1730 |
|---|---|
| N.J.Wiendels@lumc.nl |
Study information
| Study design | Randomised, double blind, double dummy, crossover study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Patients prefer rizatriptan over ibuprofen for the acute treatment of migraine. |
| Ethics approval(s) | Ethics approval received from the local Medical Ethics Committee. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Rizatriptan, ibuprofen |
| Primary outcome measure | 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 study start date | 23/03/2005 |
| Completion date | 09/11/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 35 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 23/03/2005 |
| Date of final enrolment | 09/11/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Center
Leiden
2300 RC
Netherlands
2300 RC
Netherlands
Sponsor information
Merck Sharp and Dohme BV (MSD) (The Netherlands)
Industry
Industry
P.O. Box 581
Haarlem
2003 PC
Netherlands
| Phone | +31 (0)23 515 3153 |
|---|---|
| msdbvnl@merck.com | |
| Website | http://www.msd.nl/ |
"ROR" |
https://ror.org/05y28vr04 |
Funders
Funder type
Industry
Merck Sharp and Dohme BV (MSD) (The Netherlands)
No information available
Booth Healthcare International (The Netherlands) - now Reckittbenckiser
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
