Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male and female patients between 18 and 65 years old
Moderate episodic tension headache according to International Headache Society (I.H.S.) classification 2.1 (2.1.1 and 2.1.2) for at least one year
At least two episodes of tension headache per month in the last three months prior to enrolment into this trial
The episodes of tension headaches were usually treated by the patient successfully with a non-opioid-analgesic
First episodic headache occurred at an age under 50 years
Written informed consent according to Good Clinical Practice (GCP) and local regulations
The patient was able to fill in the Patient's Diary
You may not be if
The patient usually needs for successful treatment of tension headache "Over The Counter" (OTC) analgesic in doses exceeding the doses tested here
The patient takes an OTC-analgesic normally at the first signs of an episode of tension headache
The patient has more than 15 episodes of tension headache per month
Female patients whose episodic tension headache is strongly correlated with the start of hormonal contraception
Concomitant treatment with (non-) prescriptional analgesics
Pre- (less than 4 weeks prior to inclusion in this trial) and/or concomitant treatment with an antidepressive and/or antipsychotic drug
Pre- (less than 2 weeks prior to inclusion in this trial) and/or concomitant treatment with any drug such as NSAIDs (Non-Steroidal Anti Inflammatory Drugs), propanolol, metroprolol, flunarizin, cyclandelate, valproic-acid, serotonergic antagonists, ergotamine, dihydroergotamines and benzodiazepines that may influence the headache symptomatology
Use of benzodiazepines in the previous 24 hours to the administration of the study drug. Occasional use of benzodiazepines - up to 3 per week - is allowed
Use of any drug with analgesic properties in the previous 24 hours to the administration of the study drug
Concomitant treatment with any drug containing ASA and/or metamizol
Concomitant treatment with anticoagulants such as heparin or coumarin-derivatives
Alcohol and drug abuse according to DSM-IV (Diagnostic and Statistical Manual of Mental Disorders )
Female patients in child-bearing age not using adequate means of birth control
Pregnancy and/or lactation
Gastrointestinal ulcers
Liver and/or renal disease
Bronchial asthma
Relevant allergy or known hypersensitivity to the investigational drugs, its excipients and/or to other NSAIDs
Participation in another clinical trial within the last 4 weeks and concurrent participation in another clinical trial
Patients with active gastroesophageal flux disease (Amendment number 1)
Concomitant treatment with analgesics or any other drug that may have influenced the headache symptomatology - including metamizol or ASA -, was referred to its use during the headache episodes under evaluation. As long as appropriate wash-out periods were respected, analgesics were allowed in between the episodes of tension headache (TH) and their use as a rescue medication did not lead to the exclusion of the patient (Amendment number 2)
