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Headache Disorders, PrimaryPRESTONCT02115269

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

An observational study of Headache Disorders, Primary and Migraine With Aura, run by Abbott at 30 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 99 years
How many people
759 participants
Where
30 sitesin 2 countries
Study dates
Jun 2014to Nov 2015
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

30 sites in 2 countries.

30 sites in 2 countries

Kazakhstan15 sites

  • Research facility ID ORG-000986

    Aktobe, 030000

  • LLP Medical Centre "Medical Assistance Group"

    Almaty, 050000

  • Research facility ID ORG-000994

    Almaty, 050000

  • Research facility ID ORG-000990

    Astana, 010000

  • Research facility ID ORG-000991

    Astana, 010000

  • Research facility ID ORG-000992

    Astana, 010000

  • State enterprise on the right of business City Clinic №1

    Astana, 10000

  • LLP "State Center for Primary Health Care"

    Karaganda, 100008

  • LLP Clinic "Alanda"

    Karaganda, 100008

  • State enterprise on the right of business City Clinic №2

    Karaganda, 90005

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

    Kostanay, 110000

  • LLP "Aksim-plus"

    Kostanay, 110000

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

    Semey, 71400

  • Research facility ID ORG-000989

    Shymkent, 160000

  • State communal enterprise " City emergency health care hospital"

    Shymkent, 160000

Other trials in Kazakhstan

Ukraine15 sites

  • Research facility ORG-001131

    Dnipropetrovsk, 49000

  • Research facility ORG-001127

    Kharkiv, 61068

  • Research facility ID ORG-000999

    Kharkiv, 61176

  • Research facility ID ORG-000335

    Kiev, 04112

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

    Kyiv, 03110

  • "Public Institution 'Volyn Regional Clinical Hospital',

    Lutsk, 43005

  • Research facility ID ORG-001001

    Lviv, 79010

  • Research facility ID ORG-001004

    Lviv, 79010

  • Research facility ID ORG-001000

    Mukachevo, 89600

  • Research facility ID ORG-000340

    Mykolaiv, 54001

  • Research facility ORG-001130

    Odesa, 65080

  • Research faciity ID ORG-001003

    Odesa, 65113

  • Research facility ORG-001129

    Poltava, 36011

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

    Zaporizhzhya, 69063

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

    Zaporizhzhya, 69065

Other trials in Ukraine

About this study

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

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.

Read the 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.

Keywords
Indoprocaf, Indomethacin, Caffeine, Prochlorperazine, Migraine with Aura, Migraine without Aura, Tension-Type Headache
Medical subject headings
Headache Disorders, Primary, Migraine with Aura, Migraine without Aura, Tension-Type Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02115269
Study groupRoleWhat they receive
primary headachesAdults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: up to 2 hours

  2. 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.

    Measured: up to 24 hours post dose

Secondary outcomes (4)

  1. 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

    Measured: up to 24 hours post-dose

  2. 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

    Measured: up to 2 hours

  3. 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

    Measured: up to 48 hours

  4. 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)

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionNov 2015
  4. Study completionNov 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
759 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02115269
Sponsor's protocol ID
P14-389
Acronym
PRESTO
Status last verified
Oct 2017
First submitted
9 Apr 2014
Last updated
6 Nov 2017
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Headache Disorders, Primary and Migraine With Aura, run by Abbott at 30 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Kazakhstan, Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients With Significant Pain Reduction (time frame: up to 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02115269.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.

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