A preference trial with naratriptan 2.5 mg and paracetamol 1000 mg in migraine patients in the general practice

Completed

• Conditions: Migraine; Nervous System Diseases

• Registration Number: ISRCTN57387771
• Lead Sponsor: eiden University Medical Centre (LUMC) (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-16
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
1. Changes in quality of life<br>2. Pain free rate at 2 hours postdose