A Six Month, Safety Follow-up Study in Eosinophilic Esophagitis Subjects Who Completed Study PR-021
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 12 - 55 |
| Updated: | 2/10/2017 |
| Start Date: | January 2012 |
| End Date: | April 2013 |
Six Month Safety Follow-up Study for PR-021 [Multicenter, Randomized, Double-blind, Placebo-controlled, Safety and Tolerability Phase 1/2a Study of Two Dosing Regimens of EUR-1100 for Oral Use, in Eosinophilic Esophagitis Subjects]
This purpose of this study is the long-term follow-up of glucocorticosteroid-related adverse
events and hypothalamic-pituitary-adrenal axis (HPA) suppression in subjects after
discontinuation of study drug received in the PR-021 study (Safety and Tolerability Study of
Oral EUR-1100 to Treat Eosinophilic Esophagitis). The study will also provide the
opportunity to better understand the natural course of eosinophilic esophagitis and define
the treatment modalities of eosinophilic esophagitis with EUR-1100, such as the need for
chronic maintenance or intermittent treatment.
All subjects who complete PR-021 will be offered the opportunity to participate in this
study. The duration of this follow-up study is six months, during which subjects will visit
the clinic for safety evaluation and clinical symptom assessment at the screening, Week 8,
Week 16, and Week 24 visits. Additional phone visits will occur at Week 4, Week 12, and Week
20.
events and hypothalamic-pituitary-adrenal axis (HPA) suppression in subjects after
discontinuation of study drug received in the PR-021 study (Safety and Tolerability Study of
Oral EUR-1100 to Treat Eosinophilic Esophagitis). The study will also provide the
opportunity to better understand the natural course of eosinophilic esophagitis and define
the treatment modalities of eosinophilic esophagitis with EUR-1100, such as the need for
chronic maintenance or intermittent treatment.
All subjects who complete PR-021 will be offered the opportunity to participate in this
study. The duration of this follow-up study is six months, during which subjects will visit
the clinic for safety evaluation and clinical symptom assessment at the screening, Week 8,
Week 16, and Week 24 visits. Additional phone visits will occur at Week 4, Week 12, and Week
20.
Inclusion Criteria:
- Subject completed full participation in Study PR-021 (Subjects discontinued
prematurely from PR-021 due to HPA axis suppression will be eligible for study
PR-022)
- Written informed consent (parent or legal guardian must sign when applicable) and
assent form, if required
- Willing and able to adhere to all study procedures
Exclusion Criteria:
- Subjects already requiring medications or procedures for the treatment of EoE at the
time of enrollment into the follow-up study, such as systemic (oral or parenteral) or
inhaled corticosteroids, esophageal dilation, Proton Pump Inhibitors (PPIs) and/or
dietary restrictions; in the case of subjects already on PPIs and /or dietary
restrictions during Study PR-021, only subjects requiring an increase in dosage of
PPIs and/or new dietary restrictions because of worsening of symptoms will be
excluded
- Any physical, mental, or social condition, history or concurrent illness or
laboratory abnormality that, in the investigator's judgment, might interfere with
study procedures or the ability of the subject to adhere to and complete the study
- Contraindication to esophagogastroduodenoscopy (EGD) or esophageal biopsy or
narrowing of the esophagus precluding EGD
- Female subjects who are pregnant or breastfeeding
- Participation in a clinical study involving an investigational drug or
investigational device
We found this trial at
6
sites
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials