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NCT Number: NCT02115269

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

Headaches are a common medical problem that physicians frequently encounter in their practice. One of key findings of The Atlas of Headache Disorders prepared by World Health Organization (WHO) is: headache disorders, including migraine and tension-type headache (TTH), are among the most prevalent disorders of mankind. The fixed combination of indomethacin, prochlorperazine and caffeine (IndoProCaf) showed efficacy and safety in acute treatment of migraine and episodic tension-type headache attacks. IndoProCaf (Difmetre®) is widely used in common daily practice only in Italy from early 1970s, is available at the Commonwealth of Independent States (CIS) pharmaceutical market now. There are limited data regarding IndoProCaf usage from post-marketing settings. This will be a first post-marketing observational study which aimed to evaluate the effectiveness and patients' satisfaction of primary headaches acute treatment in routine clinical settings in Ukraine and Kazakhstan.

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Key information

Conditions

Headache Disorders, Primary Brain Diseases Central Nervous System Diseases Headache Disorders Migraine Disorders Migraine With Aura Migraine Without Aura Nervous System Diseases Tension-Type Headache

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research facility ID ORG-000986, Aktobe, Kazakhstan

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About this study

The study is designed as a prospective, multicentre, observational, non-interventional, non-randomized, non-controlled, single arm, post-marketing study where IndoProCaf will be prescribed in the usual manner per standard clinical practice of the treating physician and in accordance with the terms of the locally approved instruction for medical use. No additional procedures (other than the standard of care) shall be applied to the patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Percentage of Patients With Significant Pain Reduction

    Time frame: up to 2 hours

    significant pain reduction defined as improvement to mild or no pain 2 hours post-dose by 4-point pain severity scale: 0 = no pain; 1 = mild headache, allowing normal activities; 2 = moderate headache, disturbing normal activities; 3 = severe headache, disabling activities, requiring bed-rest

  2. Percentage of Patients Who Are Satisfied With IndoProCaf Treatment

    Time frame: up to 24 hours post dose

    Patients are asked to evaluate their satisfaction with headache pain reduction after treatment by selecting the options: =very poor, =poor, =no opinion, =good, =very good. The satisfied patients are defined as those with =good and = very good answers.

Secondary outcomes

  1. Time to Significant Pain Reduction

    Time frame: up to 24 hours post-dose

    Time to significant pain reduction at 1, 2, 4, 6 and 24 hours post-dose period are summarized with number of patients in each category; significant pain reduction is defined as improvement to mild or no pain 2 hours post-dose by 4-point pain severity scale: 0 = no pain; 1 = mild headache, allowing normal activities; 2 = moderate headache, disturbing normal activities; 3 = severe headache, disabling activities, requiring bed-rest

  2. Percentage of Patients With Significant Pain Reduction in Case of First Dose no Response

    Time frame: up to 2 hours

    significant pain reduction defined as improvement to mild or no pain 2 hours post-dose by 4-point pain severity scale: 0 = no pain; 1 = mild headache, allowing normal activities; 2 = moderate headache, disturbing normal activities; 3 = severe headache, disabling activities, requiring bed-rest

  3. Percentage of Patients With Significant Pain Reduction in Case of Headache Relapse

    Time frame: up to 48 hours

    significant pain reduction defined as improvement to mild or no pain 2 hours post-dose by 4-point pain severity scale: 0 = no pain; 1 = mild headache, allowing normal activities; 2 = moderate headache, disturbing normal activities; 3 = severe headache, disabling activities, requiring bed-rest

  4. Percentage of Patients Who Are Satisfied With Different Medicines Previously Used for Headache Attack

    Time frame: baseline

    Defined as good and very good by Likert-type scale (e.g. very poor, poor, no opinion, good, very good)

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Collaborators

  • Almedis

Registry information

Official study title

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

Acronym: PRESTO

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 16, 2014
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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