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

NCT02183688 | Completed Phase 3

• 1 other identifier: 155.8
• Study Type: interventional
• Target: 1,889
• Locations: 0 countries
• Sites: N/A

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

Conditions

Migraine Disorders

Outcome Measures

Primary Outcomes (1)

• Calculated time to 50% pain relief, based on the pain intensity evaluated on a visual analogue scale (VAS)

  30 min., 1, 2, 3 and 4 hours after administration of the study medication

Secondary Outcomes (10)

• Percentage of patients with 50 % pain relief, evaluated on a VAS

  At least 2 hours after administration of the study medication

• Percentage of patients with 50 % pain relief, evaluated on a VAS

  At least 30 min., 1, 3, and 4 hours after administration of the study medication

• Pain intensity, evaluated on a VAS

  30 min., 1, 2, 3 and 4 hours after administration of the study medication

• Ratio of weighted sum of pain intensity difference scores to maximum achievable sum of pain intensity differences (%SPIDweighted), evaluated on a VAS

  Up to the end of the study

• Extent of impairment of daily activities, evaluated on a 4-grade verbal scale (VRS)

  Before, 30 min., 1, 2, 3 and 4 hours after administration of study drug

Study Arms (6)

ASA + paracetamol + caffeine

EXPERIMENTAL

Drug: Low dose ASA; Drug: Low dose paracetamol; Drug: Caffeine

ASA + paracetamol

ACTIVE COMPARATOR

Drug: Low dose ASA; Drug: Low dose paracetamol

ASA

ACTIVE COMPARATOR

Drug: High dose ASA

Paracetamol

ACTIVE COMPARATOR

Drug: High dose paracetamol

Caffeine

ACTIVE COMPARATOR

Drug: Caffeine

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Low dose ASA DRUG

ASA + paracetamol; ASA + paracetamol + caffeine

High dose ASA DRUG

ASA

Low dose paracetamol DRUG

ASA + paracetamol; ASA + paracetamol + caffeine

High dose paracetamol DRUG

Paracetamol

Caffeine DRUG

ASA + paracetamol + caffeine; Caffeine

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or male out-patients aged between 18 and 65 years
• Diagnosis: Headache
• Tension type headache according to international headache society (IHS) Headache Classification 2.1 (2.1.1 and 2.1.2) and/or
• Migraine according to IHS Headache Classification 1.1, 1.2.1 or
• Either a) or b), but cannot be distinctly classified
• The patient normally treats his/her headache successfully with non-prescription analgesics
• He/She has been suffering from headache for 12 months at least
• The headache first occurred before the age of 50 years
• During the previous three months, the patient has suffered from headache twice a month at least
• Informed consent according to §§ 40, 41 of the german medicines act and Good Clinical Practice (GCP)
• The patient seems likely to comply

You may not qualify if:

• The patient treats his/her headache with prescription-only analgesics or migraine remedies
• 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)
• The patient normally treats his/her headache with non-prescription analgesics in effervescent tablet form
• The patient normally takes his/her non-prescription analgesics immediately at the onset of the first signs of a headache episode
• Headache occurs on more than 10 days per month
• The typical, untreated headache normally lasts less than 4 hours without treatment
• Women with a close association between the occurrence of headache and menstruation (menstrual migraine)
• Concomitant treatment with prescription-only and/or non-prescription analgesics
• Previous or concomitant treatment with antidepressants or antipsychotic medicines (previous treatment = within the previous 4 weeks)
• Previous or concomitant treatment with anti-rheumatic or anti-inflammatory drugs that may influence the headache symptoms (previous treatment = within the previous 4 days)
• 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.)
• 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
• Concomitant treatments with anti-emetics
• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Migraine Disorders

Interventions

Aspirin; Acetaminophen; Caffeine

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2014
• First Posted: July 8, 2014
• Study Start: September 1, 1998
• Primary Completion: January 1, 2003
• Last Updated: July 8, 2014

Record last verified: 2014-07