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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02115269
First Posted: April 16, 2014
Last Update Posted: September 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Almedis
Information provided by (Responsible Party):
Abbott
  Purpose
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.

Condition
Headache Disorders, Primary Migraine With Aura Migraine Without Aura Tension-Type Headache

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official 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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Proportion 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

  • Proportion of Patients Who Are Satisfied With IndoProCaf Treatment [ Time Frame: up to 24 hours post dose ]
    defined as good and very good by Likert-type scale (e.g. very poor, poor, no opinion, good, very good)


Secondary Outcome Measures:
  • Time to Significant Pain Reduction [ Time Frame: up to 24 hours post-dose ]
    Time to significant pain reduction (i.e. 1, 2, 4, 6 or 24 hours post-dose) will be 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

  • Proportion 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

  • Proportion 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

  • Proportion 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)


Enrollment: 759
Study Start Date: June 2014
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
primary headaches
Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with migraine (with or without aura) and/or episodic TTH
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02115269


Locations
Kazakhstan
Research facility ID ORG-000986
Aktobe, Kazakhstan, 030000
LLP Medical Centre "Medical Assistance Group"
Almaty, Kazakhstan, 050000
Research facility ID ORG-000994
Almaty, Kazakhstan, 050000
Research facility ID ORG-000990
Astana, Kazakhstan, 010000
Research facility ID ORG-000991
Astana, Kazakhstan, 010000
Research facility ID ORG-000992
Astana, Kazakhstan, 010000
State enterprise on the right of business City Clinic №1
Astana, Kazakhstan, 10000
LLP "State Center for Primary Health Care"
Karaganda, Kazakhstan, 100008
LLP Clinic "Alanda"
Karaganda, Kazakhstan, 100008
State enterprise on the right of business City Clinic №2
Karaganda, Kazakhstan, 90005
Branch of the JSC " Railway Hospital of the medical catastrophes" "Kostanay railway hospital"
Kostanay, Kazakhstan, 110000
LLP "Aksim-plus"
Kostanay, Kazakhstan, 110000
State enterprise on the right of business "Consultative-diagnostic center Semey"
Semey, Kazakhstan, 71400
Research facility ID ORG-000989
Shymkent, Kazakhstan, 160000
State communal enterprise " City emergency health care hospital"
Shymkent, Kazakhstan, 160000
Ukraine
Research facility ORG-001131
Dnipropetrovsk, Ukraine, 49000
Research facility ORG-001127
Kharkiv, Ukraine, 61068
Research facility ID ORG-000999
Kharkiv, Ukraine, 61176
Research facility ID ORG-000335
Kiev, Ukraine, 04112
"Public Institution ""Kyiv City Clinical Hospital №4"", Neurology Department №1 and №2;
Kyiv, Ukraine, 03110
"Public Institution 'Volyn Regional Clinical Hospital',
Lutsk, Ukraine, 43005
Research facility ID ORG-001001
Lviv, Ukraine, 79010
Research facility ID ORG-001004
Lviv, Ukraine, 79010
Research facility ID ORG-001000
Mukachevo, Ukraine, 89600
Research facility ID ORG-000340
Mykolaiv, Ukraine, 54001
Research facility ORG-001130
Odesa, Ukraine, 65080
Research faciity ID ORG-001003
Odesa, Ukraine, 65113
Research facility ORG-001129
Poltava, Ukraine, 36011
Education and Research Medical Center "University Hospital of Zaporizhzhia State Medical University", Neurology Department
Zaporizhzhia, Ukraine, 69063
Public Institution "Zaporizhzhia City Multispecialty Clinical Hospital №9", Neurology Department
Zaporizhzhia, Ukraine, 69065
Sponsors and Collaborators
Abbott
Almedis
Investigators
Study Director: Jean-Pascal Berrou, MD Abbott
  More Information

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT02115269     History of Changes
Other Study ID Numbers: P14-389
First Submitted: April 9, 2014
First Posted: April 16, 2014
Results First Submitted: May 4, 2017
Results First Posted: September 25, 2017
Last Update Posted: September 25, 2017
Last Verified: May 2017

Keywords provided by Abbott:
Indoprocaf
Indomethacin
Caffeine
Prochlorperazine
Migraine with Aura
Migraine without Aura
Tension-Type Headache

Additional relevant MeSH terms:
Migraine Disorders
Headache
Tension-Type Headache
Migraine with Aura
Migraine without Aura
Headache Disorders
Headache Disorders, Primary
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms


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