A Study to Test the Safety and Effectiveness of MK-0974 (Telcagepant) Co-administered With Ibuprofen or Acetaminophen in Patients With Migraines With or Without Aura (MK-0974-046)
- Conditions
- -G43G43
- Registration Number
- PER-148-08
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• The patient is> 18 years old on the day he signs the informed consent.
• The patient understands the study procedures, available alternative treatments, and risks involved with the study, and agrees to participate voluntarily by giving written consent.
• The patient has had a history of migraine with or without the presence of aura for> 1 year, with> 1 and <8 severe or moderate migraine attacks per month in the 2 months prior to selection that normally last between 4 to 72 hours without receiving treatment
• The patient is (a) man, or (b) woman who is not potentially fertile, or (c) potentially fertile woman who agrees to remain in abstinence or make her partner use one of the mentioned highly efficient contraceptive methods within the duration Projected study: hormonal contraceptives, intrauterine devices (IUDs), condoms, diaphragm, vasectomy. The use of a contraceptive barrier (condoms, diaphragm) should always be complemented with the use of a spermicide. Section 3.2.3.2 of the protocol specifies the full details of the contraceptive requirements.
• The patient is willing to stay awake for at least 2 hours after administration of the study drug.
• The patient is able to read, understand, and fill out the questionnaires and diaries.
• The patient is pregnant or breastfeeding, or hopes to conceive within the projected duration of the study.
• The patient has difficulty distinguishing his migraine attacks from tension headaches.
• The patient has a history of predominantly mild migraine attacks or migraines that usually disappear spontaneously in less than 2 hours.
• The patient has hemiplegic or basilar type migraine headaches.
• The patient has> 15 headache-days a month OR has taken drugs for acute headache for more than 10 days a month in any of the 3 months prior to selection.
• The patient is taking a prophylactic drug for migraine when the prescribed daily dose was modified during the 3 months prior to selection.
• The patient was> 50 years old at the time the migraine started.
• The patient has suffered a myocardial infarction, unstable angina, coronary artery bypass surgery with graft, or other revascularization procedure, stroke, or transient ischemic attack within 3 months of selection.
• In the opinion of the investigator, the patient has clinical, laboratory or ECG evidence of uncontrolled hypertension (defined as SBP> 160 mm Hg and / or DBP> 100 mm Hg), uncontrolled diabetes, HIV disease, or significant lung disease, nephropathy, liver failure, endocrine diseases, or other systemic disease.
• In the opinion of the researcher, the patient has other confusing pain syndromes, psychiatric conditions such as uncontrolled major depression according to criteria such as DSM-IV, dementia, or significant neurological disorders in addition to migraine.
• The patient has a history of malignancy for <5 years before signing informed consent, except for properly treated basal or squamous cell skin cancer or cervical cancer in situ.
• The patient has a history of gastric or small bowel surgery (including gastric bypass surgery or band surgery), or has a disease that causes malabsorption.
• The patient has either demonstrated hypersensitivity to a serious adverse event or has experienced such an event in response to ibuprofen or acetaminophen / paracetamol.
• The patient has demonstrated hypersensitivity to a serious adverse event or has experienced such an event in response to 3 or more classes of drugs (with and without a prescription).
• The patient has a history or current evidence of a clinically significant disease that, according to the researcher, could confuse the results of the study, complicate the interpretation of the results of the study, interfere with the participation of the patient during the study, or present some additional undue risk to the patient.
• The patient has, in the opinion of the investigator, abnormal laboratory selection values according to the guidelines presented below or other clinically significant laboratory abnormality without explanation.
• The patient has taken any of the following drugs at the specified regulatory time: Strong and moderate CYP3A4 inhibitors, Strong CYP3A4 inducers and CYP3A4 specific substrates
• The patient is, at the time of signing the informed consent, a user of recreational or illegal drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence.
• The patient is legally or mentally disabled.
• The patient has donated blood products or has undergone a phlebotomy> 300 ml within 8 weeks of signing the informed consent, or intends to donate blood products or receive blood products wit
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Pain severity was rated by the participants in a paper diary by grade; Grade 0 (no pain), Grade 1 (mild pain), Grade 2 (moderate pain), and Grade 3 (severe pain). Pain freedom was defined as a reduction in pain severity from moderate to severe migraine headache (Grade 2 or 3) to no pain (Grade 0).<br><br>Measure:Percentage of Participants With Pain Freedom at Two Hours Post-dose<br>Timepoints:2 hours post-dose<br>
- Secondary Outcome Measures
Name Time Method