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

NCT02115269 | Completed Results

• 1 other identifier: P14-389
• Study Type: observational
• Target: 759
• Locations: 2 countries
• Sites: 30

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Time to Significant Pain Reduction

  up to 24 hours post-dose

• Percentage of Patients With Significant Pain Reduction in Case of First Dose no Response

  up to 2 hours

• Percentage of Patients With Significant Pain Reduction in Case of Headache Relapse

  up to 48 hours

• Percentage of Patients Who Are Satisfied With Different Medicines Previously Used for Headache Attack

  baseline

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott: lead
• Almedis: collaborator

Study Sites (30)

Research facility ID ORG-000986

Aktobe, 030000, Kazakhstan

Location

LLP Medical Centre "Medical Assistance Group"

Almaty, 050000, Kazakhstan

Location

Research facility ID ORG-000994

Almaty, 050000, Kazakhstan

Location

Research facility ID ORG-000990

Astana, 010000, Kazakhstan

Location

Research facility ID ORG-000991

Astana, 010000, Kazakhstan

Location

Research facility ID ORG-000992

Astana, 010000, Kazakhstan

Location

State enterprise on the right of business City Clinic №1

Astana, 10000, Kazakhstan

Location

LLP "State Center for Primary Health Care"

Karaganda, 100008, Kazakhstan

Location

LLP Clinic "Alanda"

Karaganda, 100008, Kazakhstan

Location

State enterprise on the right of business City Clinic №2

Karaganda, 90005, Kazakhstan

Location

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

Kostanay, 110000, Kazakhstan

Location

LLP "Aksim-plus"

Kostanay, 110000, Kazakhstan

Location

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

Semey, 71400, Kazakhstan

Location

Research facility ID ORG-000989

Shymkent, 160000, Kazakhstan

Location

State communal enterprise " City emergency health care hospital"

Shymkent, 160000, Kazakhstan

Location

Research facility ORG-001131

Dnipropetrovsk, 49000, Ukraine

Location

Research facility ORG-001127

Kharkiv, 61068, Ukraine

Location

Research facility ID ORG-000999

Kharkiv, 61176, Ukraine

Location

Research facility ID ORG-000335

Kiev, 04112, Ukraine

Location

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

Kyiv, 03110, Ukraine

Location

"Public Institution 'Volyn Regional Clinical Hospital',

Lutsk, 43005, Ukraine

Location

Research facility ID ORG-001001

Lviv, 79010, Ukraine

Location

Research facility ID ORG-001004

Lviv, 79010, Ukraine

Location

Research facility ID ORG-001000

Mukachevo, 89600, Ukraine

Location

Research facility ID ORG-000340

Mykolaiv, 54001, Ukraine

Location

Research facility ORG-001130

Odesa, 65080, Ukraine

Location

Research faciity ID ORG-001003

Odesa, 65113, Ukraine

Location

Research facility ORG-001129

Poltava, 36011, Ukraine

Location

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

Zaporizhzhia, 69063, Ukraine

Location

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

Zaporizhzhia, 69065, Ukraine

Location

MeSH Terms

Conditions

Headache Disorders, Primary; Migraine with Aura; Migraine without Aura; Tension-Type Headache

Condition Hierarchy (Ancestors)

Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Migraine Disorders

Results Point of Contact

• Title: Jean-Pascal Berrou, Global Medical Director CNS/Pain
• Organization: Abbott

jean-pascal.berrou@abbott.com

+41614870457

Study Officials

• Jean-Pascal Berrou, MD

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2014
• First Posted: April 16, 2014
• Study Start: June 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 6, 2017
• Results First Posted: September 25, 2017

Record last verified: 2017-10

Locations

KA (15); UA (15)