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

July 7, 2014 updated by: Boehringer Ingelheim

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1889

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Active Comparator: Paracetamol
Drug: High dose paracetamol
Active Comparator: ASA
Drug: High dose ASA
Active Comparator: Caffeine
Drug: Caffeine
Experimental: ASA + paracetamol + caffeine
Drug: Caffeine
Drug: Low dose ASA
Drug: Low dose paracetamol
Active Comparator: ASA + paracetamol
Drug: Low dose ASA
Drug: Low dose paracetamol

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
30 min., 1, 2, 3 and 4 hours after administration of the study medication

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percentage of patients with 50 % pain relief, evaluated on a VAS
Time Frame: At least 2 hours after administration of the study medication
At least 2 hours after administration of the study medication
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
At least 30 min., 1, 3, and 4 hours after administration of the study medication
Pain intensity, evaluated on a VAS
Time Frame: 30 min., 1, 2, 3 and 4 hours after administration of the study medication
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
Time Frame: Up to the end of the study
Up to the end of the study
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
Before, 30 min., 1, 2, 3 and 4 hours after administration of study drug
Duration of headache
Time Frame: Up to 48 hours after onset of each headache episode
Up to 48 hours after onset of each headache episode
Global assessment of efficacy by the patient, evaluated on a 4-grade VRS
Time Frame: Within 12 hours after study drug administration
Within 12 hours after study drug administration
Global assessment of tolerability by the patient, evaluated on a 4-grade VRS
Time Frame: Within 12 hours after study drug administration
Within 12 hours after study drug administration
Number of patients with adverse events
Time Frame: Up to the end of the study
Up to the end of the study
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
After each administration of study drug during the treatment phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 1998

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2003

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 7, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 155.8

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