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)

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

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.

Study Overview

• Status: Completed
• Conditions: Headache Disorders, Primary; Tension-Type Headache; Migraine Without Aura; Migraine With Aura

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.

• Study Type: Observational
• Enrollment (Actual): 759

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with migraine (with or without aura) and/or episodic TTH

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients With Significant Pain Reduction	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	up to 2 hours
Percentage of Patients Who Are Satisfied With IndoProCaf Treatment	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.	up to 24 hours post dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Significant Pain Reduction	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	up to 24 hours post-dose
Percentage of Patients With Significant Pain Reduction in Case of First Dose no Response	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	up to 2 hours
Percentage of Patients With Significant Pain Reduction in Case of Headache Relapse	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	up to 48 hours
Percentage of Patients Who Are Satisfied With Different Medicines Previously Used for Headache Attack	Defined as good and very good by Likert-type scale (e.g. very poor, poor, no opinion, good, very good)	baseline

Collaborators and Investigators

• Sponsor: Abbott
• Collaborators: Almedis
• Investigators: Study Director: Jean-Pascal Berrou, MD, Abbott

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: April 9, 2014
• First Submitted That Met QC Criteria: April 14, 2014
• First Posted (Estimate): April 16, 2014

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: October 2, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Caffeine; Indomethacin; Prochlorperazine; Migraine with Aura; Tension-Type Headache; Migraine without Aura; Indoprocaf
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Migraine Disorders; Headache; Tension-Type Headache; Headache Disorders; Migraine without Aura; Migraine with Aura; Headache Disorders, Primary
• Other Study ID Numbers: P14-389