Pilot Study to Assess Dimethyl Fumarate Related GI Symptom Mitigation
Клучни зборови
Апстракт
Датуми
| Последен пат проверено: | 01/31/2017 |
| Прво доставено: | 07/29/2014 |
| Поднесено е проценето запишување: | 08/12/2014 |
| Прво објавено: | 08/14/2014 |
| Последното ажурирање е доставено: | 02/19/2017 |
| Последно ажурирање објавено: | 03/22/2017 |
| Датум на први доставени резултати: | 11/07/2016 |
| Датум на први доставени резултати за КК: | 11/07/2016 |
| Датум на објавување на првите резултати: | 01/05/2017 |
| Крај на датумот на започнување на студијата: | 06/30/2014 |
| Проценет датум на примарно завршување: | 05/31/2015 |
| Проценет датум на завршување на студијата: | 05/31/2015 |
Состојба или болест
Интервенција / третман
Drug: Treatment Arm
Drug: Treatment Arm
Other: Treatment Arm
Фаза
Групи за раце
| Рака | Интервенција / третман |
|---|---|
| No Intervention: Control Group Patients randomized to the standard therapy arm will be instructed to follow the normal dosing regimen for DMF with a food bolus of their choice prior to dosing. If severe symptoms (MAGIS >6.5) are noted at any time post randomization in any MAGIS category, crossover to the treatment arm will be allowed. Both groups will be asked to rate their GI symptoms over the past 24 hours using the MAGIS scale once daily. | |
| Active Comparator: Treatment Arm Patients who are randomized to the treatment arm will be instructed to take 125 mg simethicone and one tablespoon of a high fat food (peanut butter)10 minutes prior to each DMF dose. If the average MAGIS score is greater than 3.5 in the diarrhea category they will also be instructed to take 2 mg loperamide three times daily. | Drug: Treatment Arm |
Критериуми за подобност
| Возраст подобни за студии | 18 Years До 18 Years |
| Полови квалификувани за студии | All |
| Прифаќа здрави волонтери | Да |
| Критериуми | Inclusion Criteria: 1. Decision to treat with DMF must precede enrollment 2. Ability to understand the purpose and risk of the study and provide authorization for the use of protected health information in accordance with the monitoring agency 3. Men or women 18 years of age or older at the time of informed consent 4. Naïve to DMF or fumaric acid esters 5. Confirmed diagnosis of a relapsing form of multiple sclerosis as verified by the Principal Investigator Exclusion Criteria: 1. Unable to unwilling to comply with study requirements as outlined in the informed consent 2. Known active malignancies or any other major comorbidities that, in the opinion of the Investigator, would affect the outcome of the study 3. Pregnant or breastfeeding or likely to become pregnant during the course of the study. Women of child-bearing potential must practice an acceptable form of birth control 4. Previous treatment with dimethyl fumarate 5. Past history of GI malignancy, gastric ulceration refractory to medical resolution, history of gastrectomy. At the discretion of the PI, resolved GI ulceration, gastroesophageal reflux will not be exclusionary 6. Known sensitivity or allergic reaction to peanuts, simethicone, or loperamide |
Исход
Мерки на примарниот исход
1. Reported GI Symptoms [7 Weeks]
Секундарни мерки на исходот
1. Diarrhea Reduction [7 Weeks]
Други мерки на исход
1. Number of Participants With Pre-Existing GI Conditions [7 Weeks]
