OBS in Adolescent and Adults With EOE: A Phase II, Randomized, Double-Blind, Placebo Controlled, Study With an Open Label Extension

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01642212
• Date of registration: 13/07/2012
• Prospective Registration: Yes
• Primary sponsor: Shire
• Public title: OBS in Adolescent and Adults With EOE: A Phase II, Randomized, Double-Blind, Placebo Controlled, Study With an Open Label Extension
• Scientific title: Oral Budesonide Suspension (OBS) in Adolescent and Adult Subjects (11-40 Years of Age)With Eosinophilic Esophagitis: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study With an Open Label Extension
• Date of first enrolment: July 23, 2012
• Target sample size: 93
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01642212
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Study Director
• Affiliation: Shire

Key inclusion & exclusion criteria

Inclusion Criteria:

- Males and Females, age 11-40

- Histologic evidence of EoE

- History of clinical symptoms of EoE including dysphagia

- Willing to continue with dietary, environmental or medical therapy

- Ability to read and understand english

- Written Consent

Exclusion Criteria:

- Any Medical condition that may compromise the safety of the subjects or interfere with
the signs and symptoms of EoE

- Use of immunomodulatory therapy

- Current use of swallowed corticosteroids

- Esophageal strictures,varices or upper GI bleed

- Other current diseases of the GI tract

- Current viral infection or immunodeficiency condition

- Pregnancy

- Hypersensitivity to budesonide

- History of non compliance



Age minimum: 11 Years
Age maximum: 40 Years
Gender: All

Health Condition(s) or Problem(s) studied

Eosinophilic Esophagitis (EoE)

Intervention(s)

Drug: Oral Budesonide Suspension (MB-9)

Drug: Placebo

Primary Outcome(s)

Percent of Participants Who Were Histologic Responders [Time Frame: Week 16]

Change From Baseline in The Dysphagia Symptom Questionnaire (DSQ) Score at The Final Treatment Period Evaluation [Time Frame: Baseline, Week 16]

Secondary Outcome(s)

Change From Baseline in The Physician's Global Assessment (PGA) of Disease Activity at The Final Treatment Period Evaluation [Time Frame: Baseline, Week 16]

Distribution of Responses For The Patient Global Impression of Change (PGIC) Survey at The Final Treatment Evaluation [Time Frame: Week 16]

Percent of Participants With a >/= 30% And >/= 50% Reduction In The DSQ Score From Baseline to The Final Treatment Period Evaluation [Time Frame: Baseline, Week 16]

Change From Baseline in The DSQ Score Over Time [Time Frame: Baseline, Weeks 8 and 12]

Change From Baseline in The Histopathologic Epithelial Features Combined Total Score at The Final Treatment Period Evaluation [Time Frame: Baseline, Week 16]

Percent of Participants With Worsened Symptoms on The EoE Symptom Survey at The Final Treatment Period Evaluation [Time Frame: Week 16]

Change From Baseline in The Total Endoscopy Score at The Final Treatment Period Evaluation [Time Frame: Baseline, Week 16]

Percent of Participants Who Were Overall Responders at The Final Treatment Period Evaluation [Time Frame: Week 16]

Percent of Participants Who Were Symptom Responders on The DSQ+Pain Scale at The Final Treatment Period Evaluation [Time Frame: Week 16]

Percent of Participants With New Symptoms on The EoE Symptom Survey at The Final Treatment Period Evaluation [Time Frame: Week 16]

Change From Baseline in The Peak Eosinophil Count at Each Available Esophageal Level at The Final Treatment Period Evaluation [Time Frame: Baseline, Week 16]

Percent of Participants With Improved Symptoms on The Eosinophilic Esophagitis (EoE) Symptom Survey at The Final Treatment Period Evaluation [Time Frame: Week 16]

Change From Baseline in The Scores of DSQ Question 1 During The Treatment Period [Time Frame: Baseline, Weeks 8, 12, and 16]

Percent of Participants With No Change in Symptoms on The EoE Symptom Survey at The Final Treatment Period Evaluation [Time Frame: Week 16]

Change From Baseline in The Scores of DSQ Question 4 During The Treatment Period [Time Frame: Baseline, Weeks 8, 12, and 16]

Change From Baseline in The DSQ Score For The 50th Percentile of Participants at The Final Treatment Period Evaluation [Time Frame: Baseline, Week 16]

Percent of Participants Without Symptoms on The EoE Symptom Survey at The Final Treatment Period Evaluation [Time Frame: Week 16]

Percent of Days That Participants Reported That They Avoided Solid Food During The Baseline And Treatment Periods [Time Frame: From 14 days prior to the baseline visit to the final treatment period evaluation]

Percent of Participants With a Peak Eosinophil Count [Time Frame: Week 16]

Secondary ID(s)

MPI-101-06

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 07/12/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01642212