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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02115269 |
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Date of registration:
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09/04/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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IndoProCaf Effervescent Tablets Effectiveness in Acute Treatment of Migraine and/or Episodic Tension-type Headache and Patients' Satisfaction With the Treatment in Routine Clinical Practice
PRESTO |
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Scientific title:
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IndoProCaf (Difmetre®) Effervescent Tablets Effectiveness in Acute Treatment of Primary Headaches (Migraine and/or Episodic Tension-type Headache) and Patients' Satisfaction With the Treatment in Routine Clinical Practice in Ukraine and Kazakhstan |
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Date of first enrolment:
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June 2014 |
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Target sample size:
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759 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02115269 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Kazakhstan
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Ukraine
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Contacts
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Name:
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Jean-Pascal Berrou, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Abbott |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of primary headache (migraine with or without aura and/or episodic TTH) and
whose headache attacks required acute pharmacological treatment.
- Were administered IndoProCaf (Difmetre®) effervescent tablets therapy according to the
local product labelling.
- Adults 18 years and older (male, female).
- Provide Authorization to the investigator to use and/or disclose personal and/or
health data.
Exclusion Criteria:
- Meet contraindications for treatment with IndoProCaf (Difmetre®) effervescent tablets
as outlined in the latest version of local product labelling.
- Patients who are required prescription by physician of IndoProCaf and nonsteroidal
anti-inflammatory drug-containing products at the same time for acute headache attacks
treatment.
- Previous discontinuation of IndoProCaf treatment due to safety (i.e. hypersensitivity)
events, lack of efficacy.
- Female patients who are pregnant or are breast-feeding.
Age minimum:
18 Years
Age maximum:
99 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Migraine With Aura
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Migraine Without Aura
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Tension-Type Headache
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Headache Disorders, Primary
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Primary Outcome(s)
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Percentage of Patients Who Are Satisfied With IndoProCaf Treatment
[Time Frame: up to 24 hours post dose]
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Percentage of Patients With Significant Pain Reduction
[Time Frame: up to 2 hours]
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Secondary Outcome(s)
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Percentage of Patients Who Are Satisfied With Different Medicines Previously Used for Headache Attack
[Time Frame: baseline]
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Percentage of Patients With Significant Pain Reduction in Case of Headache Relapse
[Time Frame: up to 48 hours]
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Percentage of Patients With Significant Pain Reduction in Case of First Dose no Response
[Time Frame: up to 2 hours]
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Time to Significant Pain Reduction
[Time Frame: up to 24 hours post-dose]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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