A preference trial with naratriptan 2.5 mg and paracetamol 1000 mg in migraine patients in the general practice
| ISRCTN | ISRCTN57387771 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57387771 |
| Secondary identifying numbers | NTR34 |
- Submission date
- 16/05/2005
- Registration date
- 16/05/2005
- Last edited
- 02/04/2008
- 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 (LUMC)
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 | A randomised, double blind, double-dummy, cross-over study. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Traditional 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 three migraine attacks in patients from the general population, who have not used a triptan or ergot before. Hypothesis: Patients prefer naratriptan over paracetamol 1000 mg for the acute treatment of migraine attacks. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Migraine |
| Intervention | 1. Naratriptan 2.5 mg 2. Paracetamol 1000 mg Subjects will be randomised to either naratriptan or paracetamol with a cross-over after three attacks. Subjects rate their satisfaction with treatment after each attack. Preference is evaluated after the second treatment period. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Naratriptan, paracetamol |
| Primary outcome measure | 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 measures | 1. Changes in quality of life 2. Pain free rate at 2 hours postdose |
| Overall study start date | 01/01/2005 |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | 1. The subject is greater than or equal to 18 years of age at visit 1 2. The subject has a current history of migraine with or without aura according to the International Headache Society (IHS) criteria 3. The subject has experienced an average of at least one migraine day per month for six 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 |
| Key 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 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 contra-indications 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 blood pressure above 160/95 mmHg(measured three times) |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Center (LUMC)
Leiden
2300 RC
Netherlands
2300 RC
Netherlands
Sponsor information
Leiden University Medical Centre (LUMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Neurology
Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Website | http://www.lumc.nl/english/start_english.html |
|---|---|
"ROR" |
https://ror.org/027bh9e22 |
Funders
Funder type
Industry
GlaxoSmithKline (The Netherlands)
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- GlaxoSmithKline plc., GSK plc., GSK
- Location
- United Kingdom
Leiden University Medical Centre (LUMC) (The Netherlands)
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 |
