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Acetylsalicylic Acid (ASA) + Paracetamol + Caffeine Combination Compared With ASA + Paracetamol as Well as ASA, Paracetamol, and Caffeine in Headache Patients

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ClinicalTrials.gov Identifier: NCT02183688
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
To confirm the combination rationale for the combination of ASA + paracetamol + caffeine compared with the combination of ASA + paracetamol and the individual substances ASA, paracetamol, caffeine, and placebo administered orally to headache patients for two headache episodes

Condition or disease Intervention/treatment Phase
Migraine Disorders Drug: Low dose ASA Drug: High dose ASA Drug: Low dose paracetamol Drug: High dose paracetamol Drug: Caffeine Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1889 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Placebo-controlled Clinical Trial to Confirm the Rationale of the ASA + Paracetamol + Caffeine Combination Compared With ASA + Paracetamol as Well as ASA, Paracetamol, and Caffeine in Headache Patients
Study Start Date : September 1998
Actual Primary Completion Date : January 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine Headache

Arm Intervention/treatment
Experimental: ASA + paracetamol + caffeine Drug: Low dose ASA
Drug: Low dose paracetamol
Drug: Caffeine
Active Comparator: ASA + paracetamol Drug: Low dose ASA
Drug: Low dose paracetamol
Active Comparator: ASA Drug: High dose ASA
Active Comparator: Paracetamol Drug: High dose paracetamol
Active Comparator: Caffeine Drug: Caffeine
Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. Calculated time to 50% pain relief, based on the pain intensity evaluated on a visual analogue scale (VAS) [ Time Frame: 30 min., 1, 2, 3 and 4 hours after administration of the study medication ]

Secondary Outcome Measures :
  1. Percentage of patients with 50 % pain relief, evaluated on a VAS [ Time Frame: At least 2 hours after administration of the study medication ]
  2. Percentage of patients with 50 % pain relief, evaluated on a VAS [ Time Frame: At least 30 min., 1, 3, and 4 hours after administration of the study medication ]
  3. Pain intensity, evaluated on a VAS [ Time Frame: 30 min., 1, 2, 3 and 4 hours after administration of the study medication ]
  4. Ratio of weighted sum of pain intensity difference scores to maximum achievable sum of pain intensity differences (%SPIDweighted), evaluated on a VAS [ Time Frame: Up to the end of the study ]
  5. Extent of impairment of daily activities, evaluated on a 4-grade verbal scale (VRS) [ Time Frame: Before, 30 min., 1, 2, 3 and 4 hours after administration of study drug ]
  6. Duration of headache [ Time Frame: Up to 48 hours after onset of each headache episode ]
  7. Global assessment of efficacy by the patient, evaluated on a 4-grade VRS [ Time Frame: Within 12 hours after study drug administration ]
  8. Global assessment of tolerability by the patient, evaluated on a 4-grade VRS [ Time Frame: Within 12 hours after study drug administration ]
  9. Number of patients with adverse events [ Time Frame: Up to the end of the study ]
  10. Global assessment of tolerability by the investigator, evaluated on a 4-grade VRS [ Time Frame: After each administration of study drug during the treatment phase ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female or male out-patients aged between 18 and 65 years
  2. Diagnosis: Headache

    1. Tension type headache according to international headache society (IHS) Headache Classification 2.1 (2.1.1 and 2.1.2) and/or
    2. Migraine according to IHS Headache Classification 1.1, 1.2.1 or
    3. Either a) or b), but cannot be distinctly classified
  3. The patient normally treats his/her headache successfully with non-prescription analgesics
  4. He/She has been suffering from headache for 12 months at least
  5. The headache first occurred before the age of 50 years
  6. During the previous three months, the patient has suffered from headache twice a month at least
  7. Informed consent according to §§ 40, 41 of the german medicines act and Good Clinical Practice (GCP)
  8. The patient seems likely to comply

Exclusion Criteria:

  1. The patient treats his/her headache with prescription-only analgesics or migraine remedies
  2. The patient requires higher single doses of non-prescription analgesics to treat his/her headache than indicated in the patient information leaflet (e.g. more than 2 tablets of Thomapyrin tablets)
  3. The patient normally treats his/her headache with non-prescription analgesics in effervescent tablet form
  4. The patient normally takes his/her non-prescription analgesics immediately at the onset of the first signs of a headache episode
  5. Headache occurs on more than 10 days per month
  6. The typical, untreated headache normally lasts less than 4 hours without treatment
  7. Women with a close association between the occurrence of headache and menstruation (menstrual migraine)
  8. Concomitant treatment with prescription-only and/or non-prescription analgesics
  9. Previous or concomitant treatment with antidepressants or antipsychotic medicines (previous treatment = within the previous 4 weeks)
  10. Previous or concomitant treatment with anti-rheumatic or anti-inflammatory drugs that may influence the headache symptoms (previous treatment = within the previous 4 days)
  11. Treatment of concomitant illnesses with drugs containing ASA (above a daily dose of 100 mg per day), paracetamol or caffeine (e.g. for feverish common cold, etc.)
  12. Migraine prophylaxis or administration of drugs, indicated for any other reasons that influence headache symptoms, e.g.

    Propanolol, Metoprolol, Flunarizine, Cyclandelate, Valproic acid, Serotonin antagonists (pizotifen, methysergide, lisuride), Ergotamine, Dihydroergotamine, Benzodiazepines, Magnesium, Monoamine oxidase inhibitors

  13. Concomitant treatments with anti-emetics
  14. Drug abuse connected with the headache (defined as the administration of analgesics or other drugs for the treatment of acute headache on more than 10 days per month)
  15. Alcohol or drug abuse as defined by diagnostic and statistical manual of mental disorders (DSM-IV)
  16. Pregnancy and lactation
  17. Gastrointestinal ulcers
  18. Pathologically increased bleeding tendency
  19. Glucose-6-phosphate dehydrogenase deficiency
  20. Hypersensitivity to paracetamol, caffeine, ASA, salicylates, and other anti-inflammatory/anti-rheumatic agents or other allergenic substances that are relevant to the clinical trial
  21. Bronchial asthma
  22. Concomitant treatment with anticoagulants (e.g. coumarin derivates, heparin)
  23. Clinically relevant chronic or recurrent gastrointestinal symptoms
  24. Clinically relevant liver disorders
  25. Clinically relevant pre-existing renal damage
  26. Gilbert's syndrome
  27. Not successfully treated hyperthyroidism
  28. Simultaneous participation in another clinical trial
  29. Participation in another clinical trial within 4 weeks of entering this study

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02183688    
Other Study ID Numbers: 155.8
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Migraine Disorders
Headache
Pain
Neurologic Manifestations
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Acetaminophen
Caffeine
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Central Nervous System Stimulants
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents