Trials / Suspended
SuspendedNCT02582996
Cefalium® Compared to Tylenol® in the Treatment of Migraine Attacks
National, Phase III, Multicenter, Randomized, Open, Parallel, to Evaluate the Efficacy, Safety and Superiority of Cefalium® Compared to the Tylenol® in the Treatment of Migraine Attacks
- Status
- Suspended
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 336 (estimated)
- Sponsor
- Ache Laboratorios Farmaceuticos S.A. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
National clinical trials, phase III, randomized, open, parallel, study of superiority, in which three hundred thirty-six (336) participants of both sexes, aged between 18 and 65 years will be randomly allocated to one of two treatment groups. The Group 01 will use Cefalium® and group 02 will use Tylenol®.
Detailed description
Cefalium® is a combination of Caffeine + Paracetamol + dihydroergotamine mesylate + metoclopramide hydrochloride. The dihydroergotamine mesylate interacts with the serotonergic, dopaminergic and noradrenergic receptors, but it's mechanism is not totally known. The caffeine presents mechanisms that are not totally clear, but it may relieves the pain by activating of the central noradenosine pathway (pain suppressing system). The Metoclopramide hydrochloride presents an anti-emetic action and prokinetic action in the gastrointestinal tract.One of its properties is the inhibition of nausea and vomiting triggered by drugs such as ergotamine.Paracetamol, also called acetaminophen is an effective agent analgesic and antipyretic with weak anti-inflammatory activity.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Acetaminophen+Caffeine+Dihydroergotamine+Metoclopramide. | The subject must manage 02 tablets of Cefalium right after a moderate to severe migraine. |
| DRUG | Acetaminophen | The subject must manage 02 tablets of Tylenol right after a moderate to severe migraine. |
Timeline
- Start date
- 2020-04-01
- Primary completion
- 2021-04-01
- Completion
- 2021-06-01
- First posted
- 2015-10-21
- Last updated
- 2019-04-10
Locations
6 sites across 1 country: Brazil
Source: ClinicalTrials.gov record NCT02582996. Inclusion in this directory is not an endorsement.