N/A
N=759
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
Headache Disorders, Primary · Migraine With Aura · Migraine Without Aura · Tension-Type Headache
Bottom Line
View on ClinicalTrials.gov: NCT02115269 ↗Enrolled (actual)
759
Serious AEs
0.4%
Results posted
Sep 2017
Primary outcome: Primary: Percentage of Patients With Significant Pain Reduction — 90.3 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Significant Pain Reduction |
90.3 | — |
| PRIMARY Percentage of Patients Who Are Satisfied With IndoProCaf Treatment |
91.3 | — |
| SECONDARY Time to Significant Pain Reduction |
464; 252; 176; 50; 15 | — |
| SECONDARY Percentage of Patients With Significant Pain Reduction in Case of First Dose no Response |
55.6 | — |
| SECONDARY Percentage of Patients With Significant Pain Reduction in Case of Headache Relapse |
90.0 | — |
| SECONDARY Percentage of Patients Who Are Satisfied With Different Medicines Previously Used for Headache Attack |
48.4; 22.1; 29.2; 35.3; 23.5; 27.3 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02115269). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.