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| Name | Class |
|---|---|
| Almedis | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with migraine (with or without aura) and/or episodic TTH
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Pascal Berrou, MD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research facility ID ORG-000986 | Aktobe | 030000 | Kazakhstan | |||
| LLP Medical Centre "Medical Assistance Group" |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| up to 24 hours post-dose |
| 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 |
| 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 |
| 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 |
| Almaty |
| 050000 |
| Kazakhstan |
| Research facility ID ORG-000994 | Almaty | 050000 | Kazakhstan |
| Research facility ID ORG-000990 | Astana | 010000 | Kazakhstan |
| Research facility ID ORG-000991 | Astana | 010000 | Kazakhstan |
| Research facility ID ORG-000992 | Astana | 010000 | Kazakhstan |
| State enterprise on the right of business City Clinic â„–1 | Astana | 10000 | Kazakhstan |
| LLP "State Center for Primary Health Care" | Karaganda | 100008 | Kazakhstan |
| LLP Clinic "Alanda" | Karaganda | 100008 | Kazakhstan |
| State enterprise on the right of business City Clinic â„–2 | Karaganda | 90005 | Kazakhstan |
| Branch of the JSC " Railway Hospital of the medical catastrophes" "Kostanay railway hospital" | Kostanay | 110000 | Kazakhstan |
| LLP "Aksim-plus" | Kostanay | 110000 | Kazakhstan |
| State enterprise on the right of business "Consultative-diagnostic center Semey" | Semey | 71400 | Kazakhstan |
| Research facility ID ORG-000989 | Shymkent | 160000 | Kazakhstan |
| State communal enterprise " City emergency health care hospital" | Shymkent | 160000 | Kazakhstan |
| Research facility ORG-001131 | Dnipropetrovsk | 49000 | Ukraine |
| Research facility ORG-001127 | Kharkiv | 61068 | Ukraine |
| Research facility ID ORG-000999 | Kharkiv | 61176 | Ukraine |
| Research facility ID ORG-000335 | Kiev | 04112 | Ukraine |
| "Public Institution ""Kyiv City Clinical Hospital â„–4"", Neurology Department â„–1 and â„–2; | Kyiv | 03110 | Ukraine |
| "Public Institution 'Volyn Regional Clinical Hospital', | Lutsk | 43005 | Ukraine |
| Research facility ID ORG-001001 | Lviv | 79010 | Ukraine |
| Research facility ID ORG-001004 | Lviv | 79010 | Ukraine |
| Research facility ID ORG-001000 | Mukachevo | 89600 | Ukraine |
| Research facility ID ORG-000340 | Mykolaiv | 54001 | Ukraine |
| Research facility ORG-001130 | Odesa | 65080 | Ukraine |
| Research faciity ID ORG-001003 | Odesa | 65113 | Ukraine |
| Research facility ORG-001129 | Poltava | 36011 | Ukraine |
| Education and Research Medical Center "University Hospital of Zaporizhzhia State Medical University", Neurology Department | Zaporizhzhia | 69063 | Ukraine |
| Public Institution "Zaporizhzhia City Multispecialty Clinical Hospital â„–9", Neurology Department | Zaporizhzhia | 69065 | Ukraine |
| COMPLETED |
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| NOT COMPLETED |
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Safety set included all enrolled patients who have taken at least one dose of IndoProCaf
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Number of patients in full analysis set. Full analysis set included all patients who signed informed consent and complied with all the inclusion and exclusion criteria and who had at least one acceptable headache attack treated with IndoProCaf documented in the patient's diary. This population was used for the effectiveness endpoints reporting. | Posted | Number | percentage of participants | up to 2 hours |
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| 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. | Number of patients in full analysis set. Full analysis set included all patients who signed informed consent and complied with all the inclusion and exclusion criteria and who had at least one acceptable headache attack treated with IndoProCaf documented in the patient's diary. This population was used for the effectiveness endpoints reporting. | Posted | Number | percentage of participants | 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 | Number of patients in full analysis set. Full analysis set included all patients who signed informed consent and complied with all the inclusion and exclusion criteria and who had at least one acceptable headache attack treated with IndoProCaf documented in the patient's diary. This population was used for the effectiveness endpoints reporting. | Posted | Number | participants | 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 | Patients who took second IndoProCaf dose at 2 hours post-dose | Posted | Number | percentage of participants | up to 2 hours |
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| |||||||||||||||||||||||||||
| 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 | Patients who had headache relapse. Headache relapse was defined as a worsening of headache attack after 24 hours of the initial dosing and pain-free at 2h but no later than 48 hours of initial IndoProCaf dosing. | Posted | Number | percentage of participants | up to 48 hours |
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| 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) | Patients who took trip tans in the past (data are from Safety set which included all enrolled patients who have taken at least one dose of IndoProCaf). | Posted | Number | percentage of participants | baseline |
|
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Overall 33 Adverse Events (AEs) were reported in 19 (2.7%) patients who participated in this study. Three (3) events were serious. There were no AEs that exceeded 5% frequency threshold.
The most frequent (AEs) by System Organ Class (SOC) were gastrointestinal disorders and nervous system disorders, 9 AEs in 7 (1%) patients were reported in each of these groups.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 3 | 702 | 16 | 702 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension crisis | Vascular disorders |
| |||
| Face oedema | General disorders | MedDRA | Systematic Assessment |
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| Loss of consiousness | Nervous system disorders | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | Systematic Assessment |
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| Presyncope | Nervous system disorders | Systematic Assessment |
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| Tremor | Nervous system disorders | Systematic Assessment |
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| Visual impairment | Eye disorders | Systematic Assessment |
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| Asthenia | General disorders | Systematic Assessment |
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| Gait disturbance | General disorders | Systematic Assessment |
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| Oedema Peripheral | General disorders | Systematic Assessment |
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| Blood pressure increased | Investigations | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Irritability | Psychiatric disorders | Systematic Assessment |
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| Tachycardia | Cardiac disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jean-Pascal Berrou, Global Medical Director CNS/Pain | Abbott | +41614870457 | jean-pascal.berrou@abbott.com |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020325 | Migraine with Aura |
| D020326 | Migraine without Aura |
| D018781 | Tension-Type Headache |
| ID | Term |
|---|---|
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008881 | Migraine Disorders |
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| OG002 | Significant Pain Reduction at 4 Hour Post Dose | Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 4 hours post dose |
| OG003 | Significant Pain Reduction at 6 Hours Post Dose | Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 6 hours post dose |
| OG004 | Significant Pain Reduction at 24 Hours Post Dose | Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and achieved significant pain reduction at 24 hours post dose |
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| OG003 | Patients Who Took Ergotamine-based Drugs | Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and who took ergotamine-based drugs in the past |
| OG004 | Patients Who Took Antiemetics | Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and who took antiemetics in the past |
| OG005 | Patients Who Took Opioid Analgesics | Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice and who took opioid analgesics in the past |
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