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

Migraine Without Aura Clinical Trial

— PRESTO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02115269
• Other study ID #: P14-389
• Status: Completed
• Phase: N/A
• First received: April 9, 2014
• Last updated: October 2, 2017
• Start date: June 2014
• Est. completion date: November 2015

Study information

• Verified date: October 2017
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 759
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Headache Disorders
• Headache Disorders, Primary
• Migraine Disorders
• Migraine With Aura
• Migraine without Aura
• Tension-Type Headache

Locations

Country	Name	City	State
Kazakhstan	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	Research facility ID ORG-000991	Astana
Kazakhstan	Research facility ID ORG-000992	Astana
Kazakhstan	State enterprise on the right of business City Clinic ?1	Astana
Kazakhstan	LLP "State Center for Primary Health Care"	Karaganda
Kazakhstan	LLP Clinic "Alanda"	Karaganda
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	State enterprise on the right of business "Consultative-diagnostic center Semey"	Semey
Kazakhstan	Research facility ID ORG-000989	Shymkent
Kazakhstan	State communal enterprise " City emergency health care hospital"	Shymkent
Ukraine	Research facility ORG-001131	Dnipropetrovsk
Ukraine	Research facility ID ORG-000999	Kharkiv
Ukraine	Research facility ORG-001127	Kharkiv
Ukraine	Research facility ID ORG-000335	Kiev
Ukraine	"Public Institution ""Kyiv City Clinical Hospital ?4"", Neurology Department ?1 and ?2;	Kyiv
Ukraine	"Public Institution 'Volyn Regional Clinical Hospital',	Lutsk
Ukraine	Research facility ID ORG-001001	Lviv
Ukraine	Research facility ID ORG-001004	Lviv
Ukraine	Research facility ID ORG-001000	Mukachevo
Ukraine	Research facility ID ORG-000340	Mykolaiv
Ukraine	Research faciity ID ORG-001003	Odesa
Ukraine	Research facility ORG-001130	Odesa
Ukraine	Research facility ORG-001129	Poltava
Ukraine	Education and Research Medical Center "University Hospital of Zaporizhzhia State Medical University", Neurology Department	Zaporizhzhia
Ukraine	Public Institution "Zaporizhzhia City Multispecialty Clinical Hospital ?9", Neurology Department	Zaporizhzhia

Sponsors (2)

Lead Sponsor	Collaborator
Abbott	Almedis

Countries where clinical trial is conducted

Kazakhstan,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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