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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

NCT ID: NCT02115269

Last Updated: 2017-11-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

759 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Keywords

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Indoprocaf Indomethacin Caffeine Prochlorperazine Migraine with Aura Migraine without Aura Tension-Type Headache

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Almedis

INDUSTRY

Sponsor Role collaborator

Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Pascal Berrou, MD

Role: STUDY_DIRECTOR

Abbott

Locations

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Research facility ID ORG-000986

Aktobe, , Kazakhstan

Site Status

LLP Medical Centre "Medical Assistance Group"

Almaty, , Kazakhstan

Site Status

Research facility ID ORG-000994

Almaty, , Kazakhstan

Site Status

Research facility ID ORG-000990

Astana, , Kazakhstan

Site Status

Research facility ID ORG-000991

Astana, , Kazakhstan

Site Status

Research facility ID ORG-000992

Astana, , Kazakhstan

Site Status

State enterprise on the right of business City Clinic №1

Astana, , Kazakhstan

Site Status

LLP "State Center for Primary Health Care"

Karaganda, , Kazakhstan

Site Status

LLP Clinic "Alanda"

Karaganda, , Kazakhstan

Site Status

State enterprise on the right of business City Clinic №2

Karaganda, , Kazakhstan

Site Status

Branch of the JSC " Railway Hospital of the medical catastrophes" "Kostanay railway hospital"

Kostanay, , Kazakhstan

Site Status

LLP "Aksim-plus"

Kostanay, , Kazakhstan

Site Status

State enterprise on the right of business "Consultative-diagnostic center Semey"

Semey, , Kazakhstan

Site Status

Research facility ID ORG-000989

Shymkent, , Kazakhstan

Site Status

State communal enterprise " City emergency health care hospital"

Shymkent, , Kazakhstan

Site Status

Research facility ORG-001131

Dnipropetrovsk, , Ukraine

Site Status

Research facility ORG-001127

Kharkiv, , Ukraine

Site Status

Research facility ID ORG-000999

Kharkiv, , Ukraine

Site Status

Research facility ID ORG-000335

Kiev, , Ukraine

Site Status

"Public Institution ""Kyiv City Clinical Hospital №4"", Neurology Department №1 and №2;

Kyiv, , Ukraine

Site Status

"Public Institution 'Volyn Regional Clinical Hospital',

Lutsk, , Ukraine

Site Status

Research facility ID ORG-001001

Lviv, , Ukraine

Site Status

Research facility ID ORG-001004

Lviv, , Ukraine

Site Status

Research facility ID ORG-001000

Mukachevo, , Ukraine

Site Status

Research facility ID ORG-000340

Mykolaiv, , Ukraine

Site Status

Research facility ORG-001130

Odesa, , Ukraine

Site Status

Research faciity ID ORG-001003

Odesa, , Ukraine

Site Status

Research facility ORG-001129

Poltava, , Ukraine

Site Status

Education and Research Medical Center "University Hospital of Zaporizhzhia State Medical University", Neurology Department

Zaporizhzhia, , Ukraine

Site Status

Public Institution "Zaporizhzhia City Multispecialty Clinical Hospital №9", Neurology Department

Zaporizhzhia, , Ukraine

Site Status

Countries

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Kazakhstan Ukraine

Other Identifiers

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P14-389

Identifier Type: -

Identifier Source: org_study_id