EFFICACY AND TOLERABILITY OF NIMESULIDE FOR THE TREATMENT OF MIGRAINE TTACKS: A RANDOMISED, MULTICOUNTRY, DOUBLE BLIND, PLACEBO CONTROLLED, CROSS-OVER TRIAL

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-000583-28-AT

Enrollment

162

Registered

2005-09-29

Start date

2005-11-03

Completion date

Unknown

Last updated

2013-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Trade Name: AULIN 100 tablets Product Name: AULIN 100 mg tablets Pharmaceutical Form: Tablet INN or Proposed INN: nimesulide CAS Number: 51803-78-2 Concentration unit: mg milligram(s) Concentration ty

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •Adult males and females out-patients aged > 18 to =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: •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).;Secondary Objective: •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 ;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).	—

Measure

Time frame

Main Objective: •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).;Secondary Objective: •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 ;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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Countries

Austria, Italy

Outcome results