Clinical trial 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Headache Disorders, Primary
Migraine With Aura
Migraine Without Aura
Tension-Type Headache
Keywords: Indoprocaf
Indomethacin
Caffeine
Prochlorperazine
Migraine with Aura
Migraine without Aura
Tension-Type Headache
Lead sponsor: Abbott
Sponsor class: INDUSTRY
Collaborators: name: Almedis
First posted: 2014-04-16
Enrollment: 759
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with migraine (with or without aura) and/or episodic TTH

Brief summary: 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: 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 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.

Primary outcomes:
measure: Percentage of Patients With Significant Pain Reduction
timeFrame: up to 2 hours
measure: Percentage of Patients Who Are Satisfied With IndoProCaf Treatment
timeFrame: up to 24 hours post dose
Secondary outcomes:
measure: Time to Significant Pain Reduction
timeFrame: up to 24 hours post-dose
measure: Percentage of Patients With Significant Pain Reduction in Case of First Dose no Response
timeFrame: up to 2 hours
measure: Percentage of Patients With Significant Pain Reduction in Case of Headache Relapse
timeFrame: up to 48 hours
measure: Percentage of Patients Who Are Satisfied With Different Medicines Previously Used for Headache Attack
timeFrame: baseline
Other outcomes:
Locations:
city: Aktobe
country: Kazakhstan
facility: Research facility ID ORG-000986
city: Almaty
country: Kazakhstan
facility: LLP Medical Centre "Medical Assistance Group"
city: Almaty
country: Kazakhstan
facility: Research facility ID ORG-000994
city: Astana
country: Kazakhstan
facility: Research facility ID ORG-000990
city: Astana
country: Kazakhstan
facility: Research facility ID ORG-000991
city: Astana
country: Kazakhstan
facility: Research facility ID ORG-000992
city: Astana
country: Kazakhstan
facility: State enterprise on the right of business City Clinic №1
city: Karaganda
country: Kazakhstan
facility: LLP "State Center for Primary Health Care"
city: Karaganda
country: Kazakhstan
facility: LLP Clinic "Alanda"
city: Karaganda
country: Kazakhstan
facility: State enterprise on the right of business City Clinic №2
city: Kostanay
country: Kazakhstan
facility: Branch of the JSC " Railway Hospital of the medical catastrophes" "Kostanay railway hospital"
city: Kostanay
country: Kazakhstan
facility: LLP "Aksim-plus"
city: Semey
country: Kazakhstan
facility: State enterprise on the right of business "Consultative-diagnostic center Semey"
city: Shymkent
country: Kazakhstan
facility: Research facility ID ORG-000989
city: Shymkent
country: Kazakhstan
facility: State communal enterprise " City emergency health care hospital"
city: Dnipropetrovsk
country: Ukraine
facility: Research facility ORG-001131
city: Kharkiv
country: Ukraine
facility: Research facility ORG-001127
city: Kharkiv
country: Ukraine
facility: Research facility ID ORG-000999
city: Kiev
country: Ukraine
facility: Research facility ID ORG-000335
city: Kyiv
country: Ukraine
facility: "Public Institution ""Kyiv City Clinical Hospital №4"", Neurology Department №1 and №2;
city: Lutsk
country: Ukraine
facility: "Public Institution 'Volyn Regional Clinical Hospital',
city: Lviv
country: Ukraine
facility: Research facility ID ORG-001001
city: Lviv
country: Ukraine
facility: Research facility ID ORG-001004
city: Mukachevo
country: Ukraine
facility: Research facility ID ORG-001000
city: Mykolaiv
country: Ukraine
facility: Research facility ID ORG-000340
city: Odesa
country: Ukraine
facility: Research facility ORG-001130
city: Odesa
country: Ukraine
facility: Research faciity ID ORG-001003
city: Poltava
country: Ukraine
facility: Research facility ORG-001129
city: Zaporizhzhia
country: Ukraine
facility: Education and Research Medical Center "University Hospital of Zaporizhzhia State Medical University", Neurology Department
city: Zaporizhzhia
country: Ukraine
facility: Public Institution "Zaporizhzhia City Multispecialty Clinical Hospital №9", Neurology Department
Study officials:
affiliation: Abbott
name: Jean-Pascal Berrou, MD
role: STUDY_DIRECTOR
References: