E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
•Moderate or severe attacks relieved (i.e. pain reduced by two point on a 4 point scale of “no pain-mild-moderate-severe) or mild attacks aborted (i.e. pain reduced by one point) within 2 hours after treatment with nimesulide or placebo (pain relief at 2 hours). |
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E.2.2 | Secondary objectives of the trial |
•Moderate or severe attacks aborted within 1 and 2 hours (pain free at 1 and 2 hours) •Moderate or severe attacks relieved or mild attacks aborted within 15, 30 and 60 min (pain relief at 15, 30 and 60 min) •Attacks of any intensity with reduction of the VAS •Recurrence of a previously aborted attack of any intensity within the next 24 and 48 hours (headache recurrence at 24 and 48 hours) •Percentage of attacks that do not fully redevelop within 24 hours (mild recurrence) •Percentage of attacks treated with rescue medication •Patients’ preference of drugs used to treat all attacks •Functional disability •Attacks with adverse events •Attacks with accompanying symptoms within 2 hours (i.e. nausea, vomiting, photo and/or phonofobia and osmiophobia) •Attacks with residual cutaneous allodynia
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
•Adult males and females out-patients aged > 18 to < 65 years; •Migraine with and / or without aura for more than 1 year following the ICHD II ( The International Classification of the Headache Disorders 2004 ) ( Appendix no. 3 ) •Frequency of attacks of more than one but less than 6 attacks per month ( in any case less than fifteen headache days per month ); •Age at migraine onset < 50 years; •Ability to differentiate headache attacks that are not migraine from the very beginning of the attack; •Physical examination results, including vital signs within the reference ranges or clinically acceptable to the Investigator; •Able and willing to give written informed consent;
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E.4 | Principal exclusion criteria |
•Patients with more than one out of three attacks on waking; •Patients with known hypersensitivity to nimesulide or to any of the excipients of the products; •Presence or intention of pregnancy and breast feeding; •Patients with hepatic impairment; •Severe renal impairment or severe heart failure; •Patients with abnormal routine laboratory biochemistry parameters (especially SGOT, GPT, GT and bilirubin) at screening. •Patients with metabolic or other diseases like malignancy and major psychiatric disorders that, in the view of the investigator, could compromise the patient’s participation in the study; •Patients with history of hypersensitivity reactions (i.e.: bronchospasm, rhinitis, urticaria) in response to acetylsalicylic acid or other non steroidal anti-inflammatory drugs. •Patients with obstructive pulmonary disease; •Concurrent treatment with glucocorticoids (unless given as supplements); •Patients with active gastric or duodenal ulcer, a history of recurrence ulceration or gastrointestinal bleeding, cerebrovascolar bleeding or other active bleeding or bleeding disorders; •Patients with severe coagulation disorders; •Patients taking drugs during the previous three months in doses likely to produce amnesia during the study period (e.g. benzodiazepines, psychotropic and major tranquillisers); •Treatments with oral contraceptive or prophylactic medication for migraine if taken for less than 2 months before the study start and/or modified during the trial; •Patients with known contraindication to nimesulide or to any of the excipients of the products; •Patients with known hepatotoxicity reaction in response to nimesulide; •Patients using nimesulide or other NSAIDs and/or ASA on a daily basis; •Patients who abuse of alcohol or other drugs; •Patients who are treated with hepatotoxic drugs; •Patients who have used any investigational drug and/or participated in any clinical trial within 3 months of entry to this study; •Patients unable to give a valid informed consent or unable to properly follow the protocol. •Employees of the investigator or study centre (i.e., principal investigator, sub-investigator, study coordinators, other study staff, employees, or contractors of each), with direct involvement in the proposed study or other studies under the direction of that investigator and/or study centre, as well as family members of the employees or the investigator.
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E.5 End points |
E.5.1 | Primary end point(s) |
•Moderate or severe attacks relieved (i.e. pain reduced by two point on a 4 point scale of “no pain-mild-moderate-severe) or mild attacks aborted (i.e. pain reduced by one point) within 2 hours after treatment with nimesulide or placebo (pain relief at 2 hours). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 9 |