An observational study in Headache Disorders, Primary, Migraine With Aura and Migraine Without Aura, sponsored by Abbott. Completed at 30 sites in 2 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2017-11-06.
Sponsored by Abbott · Observational
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.
42 studies on the registry are indexed under Headache Disorders, Primary; 13 are open to participants now.
This study's enrollment of 759 is above the median of 120 across 21 observational studies indexed under Headache Disorders, Primary.
Browse Headache Disorders, Primary studies →Abbott is the lead sponsor of 361 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with migraine (with or without aura) and/or episodic TTH
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice
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
Time frame: 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.
Time frame: up to 24 hours post dose
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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: baseline
| Milestone | Primary Headaches |
|---|---|
| Started | 759 |
| Completed | 702 |
| Not completed | 57 |
| Withdrew: Lost to follow-up | 43 |
| Withdrew: Did not complete patient diary | 3 |
| Withdrew: Moved to another city | 7 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Didn't take study drug | 2 |
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
| percentage of participants | Primary Headaches |
|---|---|
| Percentage of Patients With Significant Pain Reduction | 90.3 |
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.
| percentage of participants | Primary Headaches |
|---|---|
| Percentage of Patients Who Are Satisfied With IndoProCaf Treatment | 91.3 |
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
| participants | Significant Pain Reduction at 1 Hour Post Dose | Significant Pain Reduction at 2 Hours Post Dose | Significant Pain Reduction at 4 Hour Post Dose | Significant Pain Reduction at 6 Hours Post Dose | Significant Pain Reduction at 24 Hours Post Dose |
|---|---|---|---|---|---|
| Time to Significant Pain Reduction | 464 | 252 | 176 | 50 | 15 |
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
| percentage of participants | Primary Headaches |
|---|---|
| Percentage of Patients With Significant Pain Reduction in Case of First Dose no Response | 55.6 |
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
| percentage of participants | Primary Headaches |
|---|---|
| Percentage of Patients With Significant Pain Reduction in Case of Headache Relapse | 90.0 |
Defined as good and very good by Likert-type scale (e.g. very poor, poor, no opinion, good, very good)
| percentage of participants | Patients With Primary Headaches and Took Triptans in the Past | Patients With Primary Headaches Who Took NSAIDs and Analgesics | Patients Who Took Combined Analgesics | Patients Who Took Ergotamine-based Drugs | Patients Who Took Antiemetics | Patients Who Took Opioid Analgesics |
|---|---|---|---|---|---|---|
| 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 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Primary Headaches | — | 3/702 (0.4%) | 16/702 (2.3%) |
| Event | Primary Headaches |
|---|---|
| Hypertension crisisVascular disorders | 1/702 |
| Face oedemaGeneral disorders | 1/702 |
| Loss of consiousnessNervous system disorders | 1/702 |
| Event | Primary Headaches |
|---|---|
| DizzinessNervous system disorders | 5/702 |
| NauseaGastrointestinal disorders | 4/702 |
| Visual impairmentEye disorders | 3/702 |
| Abdominal pain upperGastrointestinal disorders | 2/702 |
| DyspepsiaGastrointestinal disorders | 2/702 |
| Blood pressure increasedInvestigations | 2/702 |
| VomitingGastrointestinal disorders | 1/702 |
| HypoaesthesiaNervous system disorders | 1/702 |
| PresyncopeNervous system disorders | 1/702 |
| TremorNervous system disorders | 1/702 |
Safety set included all enrolled patients who have taken at least one dose of IndoProCaf
| Age, Continuous(years) | Primary Headaches |
|---|---|
| Mean | 39.6 ± 11.0 |
| Sex: Female, Male(Participants) | Primary Headaches |
|---|---|
| Female | 542 |
| Male | 160 |
| Region of Enrollment(Participants) | Primary Headaches |
|---|---|
| Ukraine | 432 |
| Kazakhstan | 270 |
The record gives a start of Jun 2014, a primary completion of Nov 2015 and a completion of Nov 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Sep 2017, 1 year 10 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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