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

Completed

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

• Registration Number: NCT02115269
• Lead Sponsor: Abbott

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.

Study Timeline

• Study First Submitted: 2014-04-09
• Study First Submitted QC: 2014-04-14
• Study First Posted: 2014-04-16
• Study Start: 2014-06
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Results First Submitted: 2017-05-04
• Results First Submitted QC: 2017-05-04
• Results First Posted: 2017-09-25
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-02
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 759

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Significant Pain Reduction	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
Percentage of Patients Who Are Satisfied With IndoProCaf Treatment	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 Outcome Measures

Name	Time	Method
Time to Significant Pain Reduction	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
Percentage of Patients With Significant Pain Reduction in Case of First Dose no Response	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
Percentage of Patients With Significant Pain Reduction in Case of Headache Relapse	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
Percentage of Patients Who Are Satisfied With Different Medicines Previously Used for Headache Attack	baseline	Defined as good and very good by Likert-type scale (e.g. very poor, poor, no opinion, good, very good)

Trial Locations

Locations (30)

LLP "State Center for Primary Health Care"; 🇰🇿 Karaganda, Kazakhstan

State communal enterprise " City emergency health care hospital"; 🇰🇿 Shymkent, Kazakhstan

Research facility ID ORG-001000; 🇺🇦 Mukachevo, Ukraine

Research facility ID ORG-000991; 🇰🇿 Astana, Kazakhstan

Research facility ORG-001127; 🇺🇦 Kharkiv, Ukraine

Research facility ID ORG-000340; 🇺🇦 Mykolaiv, Ukraine

Research facility ORG-001129; 🇺🇦 Poltava, Ukraine

Research facility ID ORG-000992; 🇰🇿 Astana, Kazakhstan

State enterprise on the right of business City Clinic №2; 🇰🇿 Karaganda, Kazakhstan

Branch of the JSC " Railway Hospital of the medical catastrophes" "Kostanay railway hospital"; 🇰🇿 Kostanay, Kazakhstan

LLP "Aksim-plus"; 🇰🇿 Kostanay, Kazakhstan

Research facility ID ORG-000335; 🇺🇦 Kiev, Ukraine

Research facility ID ORG-001004; 🇺🇦 Lviv, Ukraine

LLP Clinic "Alanda"; 🇰🇿 Karaganda, Kazakhstan

Public Institution "Zaporizhzhia City Multispecialty Clinical Hospital №9", Neurology Department; 🇺🇦 Zaporizhzhia, Ukraine

Research facility ID ORG-000986; 🇰🇿 Aktobe, Kazakhstan

LLP Medical Centre "Medical Assistance Group"; 🇰🇿 Almaty, Kazakhstan

Research facility ID ORG-000994; 🇰🇿 Almaty, Kazakhstan

Research facility ID ORG-000990; 🇰🇿 Astana, Kazakhstan

State enterprise on the right of business "Consultative-diagnostic center Semey"; 🇰🇿 Semey, Kazakhstan

Research facility ID ORG-000999; 🇺🇦 Kharkiv, Ukraine

Research facility ID ORG-000989; 🇰🇿 Shymkent, Kazakhstan

State enterprise on the right of business City Clinic №1; 🇰🇿 Astana, Kazakhstan

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

Research faciity ID ORG-001003; 🇺🇦 Odesa, Ukraine

"Public Institution 'Volyn Regional Clinical Hospital',; 🇺🇦 Lutsk, Ukraine

Research facility ORG-001130; 🇺🇦 Odesa, Ukraine

Education and Research Medical Center "University Hospital of Zaporizhzhia State Medical University", Neurology Department; 🇺🇦 Zaporizhzhia, Ukraine

Research facility ORG-001131; 🇺🇦 Dnipropetrovsk, Ukraine

Research facility ID ORG-001001; 🇺🇦 Lviv, Ukraine