Clinical Trial: 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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 Summary: 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.
Sponsor: Abbott

Current Primary Outcome:

• Proportion of patients with significant pain reduction [ Time Frame: 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
• Proportion of patients who are satisfied with IndoProCaf treatment [ Time Frame: up to 24 hours post dose ]
  defined as good and very good by Likert-type scale (e.g. very poor, poor, no opinion, good, very good)

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Time to significant pain reduction [ Time Frame: up to 24 hours post-dose ]
  Time will be measured as 1, 2, 4, 6 or 24 hours post-dose; 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
• Proportion of patients with significant pain reduction in case of first dose no response [ Time Frame: 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
• Proportion of patients with significant pain reduction in case of headache relapse [ Time Frame: 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
• Proportion of patients who are satisfied with different medicines previously used for headache attack [ Time Frame: baseline ]
  defined as good and very good by Likert-type scale (e.g. very poor, poor, no opinion, good, very good)

Original Secondary Outcome: Same as current

Information By: Abbott

Dates:
Date Received: April 9, 2014
Date Started: June 2014
Date Completion:
Last Updated: November 18, 2015
Last Verified: November 2015