Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Dr. Falk Pharma GmbH
Study ID
NCT06596252
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Budesonide — DRUG
    Twice daily intake of the tablet 30 min after a meal

Study Details

The purpose of this study is to prove the non-inferiority of a 6-weeks treatment with 1 mg budesonide orodispersible tablets BID versus 2 mg budesonide orodispesible tabletss for the induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis.

Key Dates

Start date
May 21, 2021
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
308 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Budesonide 2 mg orodispersible tablet once daily
  • Active Comparator: Arm B
    Budesonide 1 mg orodispersible tablet twice daily
  • Experimental: OLE
    Open label extension with Budesonide 0.5 mg or 1 mg orodispersible tablet twice daily

Primary Outcome Measure

Proportion of patients in histological remission [ Time Frame: 6 weeks ]

Central Contacts

Locations (25)

FacilityCityStateZIPSite coordinators
Dr. Falk Investigational SiteScottsdaleArizona85259-
Dr. Falk Investigational SiteLittle RockArkansas72205-
Dr. Falk Investigational SiteLa JollaCalifornia92037
858-824-4151
Dr. Falk Investigational SiteLomitaCalifornia90717-
Dr. Falk Investigational SiteSan DiegoCalifornia92193-
Dr. Falk Investigational SiteDoralFlorida83706-
Dr. Falk Investigational SiteNew Port RicheyFlorida34653-
Dr. Falk Investigational SiteBoiseIdaho83706
208-813-6505
Dr. Falk Investigational SiteHoumaLouisiana70363
985-219-6501
Dr. Falk Investigational SiteMarreroLouisiana70072
504-934-8424
Dr. Falk Investigational SiteBostonMassachusetts02111
617-804-6767
WyomingAnn ArborMichigan48109-
Dr. Falk Investigational SiteWyomingMichigan49519-
Dr. Falk Investigational SiteRochesterMinnesota55905
507-284-2511
Dr. Falk Investigational SiteFreeholdNew Jersey07728
504-934-8424
Dr. Falk Investigational SiteJacksonNew Jersey08527
732-724-2500
Dr. Falk Investigational SiteNew YorkNew York10075-
Dr. Falk Investigational SiteChapel HillNorth Carolina27599-7080
919-966-2996
Dr. Falk Investigational SiteClevelandOhio44195
216-444-7691
Dr. Falk Investigational SiteMentorOhio44060-
WyomingPhiladelphiaPennsylvania19104-
Dr. Falk Investigational SiteHarlingenTexas78550
956-377-4371
Dr. Falk Investigational SiteSalt Lake CityUtah85259
480-301-6292
Dr. Falk Investigational SiteCharlottesvilleVirginia22903-
Dr. Falk Investigational SiteLynchburgVirginia24502-

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Dr. Falk Investigational Site· Scottsdale, AZDr. Falk Investigational Site· Little Rock, ARDr. Falk Investigational Site· La Jolla, CADr. Falk Investigational Site· Lomita, CADr. Falk Investigational Site· San Diego, CADr. Falk Investigational Site· Doral, FL

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