Trial · NCT03245840
Continuation Study With Budesonide Oral Suspension (BOS) for Adolescent and Adult Participants With Eosinophilic Esophagitis (EoE)
NCT03245840, Phase 3, Terminated, Shire; results first posted 2022-12-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Continuation Study With Budesonide Oral Suspension (BOS) for Adolescent and Adult Participants With Eosinophilic Esophagitis (EoE). Trials, record NCT03245840. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03245840
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Continuation Study With Budesonide Oral Suspension (BOS) for Adolescent and Adult Participants With Eosinophilic Esophagitis (EoE)
- NCT number
- NCT03245840
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 133 participants, actual
- Lead sponsor
- Shire
- Conditions
- Eosinophilic Esophagitis (EoE)
- Interventions
- Budesonide oral suspension
- First posted
- 2017-08-10
- Last updated
- 2025-02-19
- Results first posted
- 2022-12-07
- Limitations and caveats
- The study was discontinued prematurely as per sponsor's decision.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | From start of study drug administration up to End of study (EOS) (Up to Month 53) | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A Serious Adverse Event (SAE) was any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect, and is an important medical event. Both serious and Non-serious TEAEs were reported in this outcome measure. TEAEs were defined as AEs with a start date on or after the first dose of investigational product or a start date before the date of the first dose of investigational product that increased in severity or after the date of the first dose. |
| Primary | Number of Participants With Clinically Significant Physical Examination Findings | From start of study drug administration up to EOS (Up to Month 53) | Number of participants with clinically significant physical examination findings were reported. Clinical significance was determined by investigator. |
| Primary | Number of Participants With Clinically Significant Change From Baseline in Vital Signs | From start of study drug administration up to EOS (Up to Month 53) | Participants were assessed by investigator for any clinically significant changes in vital parameters like temperature, systolic and diastolic blood pressure, pulse, respiratory rate, BMI, and weight. Vital signs were assessed after the participant had been in a supine position for at least 5 minutes immediately prior to the assessment. The criteria for clinically significant change was as per the investigators discretion. |
| Primary | Change From Baseline in Bone Mineral Density (BMD) For Adolescents Assessed by Dual-Energy X-ray Absorptiometry (DXA) Scan at Month 12 | Baseline, Month 12 | The sites for DXA measurement were the lumbar spine at lumbar vertebrae 1 to 4 (L1-L4) and whole body. DXA scans for determination of BMD and body composition was performed in participants aged 11-17 years. Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. In this study, the BMD Z-score is considered abnormal when the z-score is less than (\<) -2, suggesting a worse outcome (i.e., osteoporosis). Change from baseline in BMD for adolescents assessed by DXA Scan at Month 12 was reported. |
| Primary | Change From Baseline in BMD For Adolescents Assessed by DXA Scan at Month 24 | Baseline, Month 24 | The sites for DXA measurement were the lumbar spine at lumbar vertebrae 1 to 4 (L1-L4) and whole body. DXA scans for determination of BMD and body composition was performed in participants aged 11-17 years. Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. In this study, the BMD Z-score is considered abnormal when the z-score is \<-2, suggesting a worse outcome (i.e., osteoporosis) and vice versa. Change from baseline in BMD for adolescents assessed by DXA Scan at Month 24 was reported. |
| Primary | Change From Baseline in BMD For Adolescents Assessed by DXA Scan at Month 36 | Baseline, Month 36 | The sites for DXA measurement were the lumbar spine at lumbar vertebrae 1 to 4 (L1-L4) and whole body. DXA scans for determination of BMD and body composition was performed in participants aged 11-17 years. Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. In this study, the BMD Z-score is considered abnormal when the z-score is \< -2, suggesting a worse outcome (i.e., osteoporosis) and vice versa. Change from baseline in BMD for adolescents assessed by DXA Scan at Month 36 was reported. |
| Primary | Change From Baseline in BMD For Adolescents Assessed by DXA Scan at Month 48 | Baseline, Month 48 | The sites for DXA measurement were the lumbar spine at lumbar vertebrae 1 to 4 (L1-L4) and whole body. DXA scans for determination of BMD and body composition was performed in participants aged 11-17 years. Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. In this study, the BMD Z-score is considered abnormal when the z-score is \< -2, suggesting a worse outcome (i.e., osteoporosis) and vice versa. Change from baseline in BMD for adolescents assessed by DXA Scan at Month 48 was reported. |
| Primary | Change From Baseline in BMD For Adolescents Assessed by DXA Scan at EOS (Up to Month 53) | Baseline, EOS (Up to Month 53) | The sites for DXA measurement were the lumbar spine at lumbar vertebrae 1 to 4 (L1-L4) and whole body. DXA scans for determination of BMD and body composition was performed in participants aged 11-17 years. Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. In this study, the BMD Z-score is considered abnormal when the z-score is \< -2, suggesting a worse outcome (i.e., osteoporosis) and vice versa. Change from baseline in BMD for adolescents assessed by DXA Scan at EOS (up to Month 53) was reported. |
| Primary | Change From Baseline in Cortisol Level After Adrenocorticotropic Hormone (ACTH) Stimulation at Month 12 | Baseline, Month 12 | ACTH testing was a standard procedure to measure the levels of cortisol in the blood following the injection of a synthetic form of ACTH (250 microgram \[mcg\]). The type of synthetic and route of administration was per investigator discretion. The change from baseline in cortisol levels was calculated at Month 12 and reported in this outcome measure. |
| Primary | Change From Baseline in Cortisol Level After ACTH Stimulation at Month 24 | Baseline, Month 24 | ACTH testing was a standard procedure to measure the levels of cortisol in the blood following the injection of a synthetic form of ACTH (250 microgram \[mcg\]). The type of synthetic and route of administration was per investigator discretion. The change from baseline in cortisol levels was calculated at Month 24 and reported in this outcome measure. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | From start of study drug administration up to End of study (EOS) (Up to Month 53) | The safety set consisted of all participants who received at least 1 dose of BOS. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Physical Examination Findings | From start of study drug administration up to EOS (Up to Month 53) | The safety set consisted of all participants who received at least 1 dose of BOS. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Change From Baseline in Vital Signs | From start of study drug administration up to EOS (Up to Month 53) | The safety set consisted of all participants who received at least 1 dose of BOS. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Bone Mineral Density (BMD) For Adolescents Assessed by Dual-Energy X-ray Absorptiometry (DXA) Scan at Month 12 | Baseline, Month 12 | The safety set consisted of all participants who received at least 1 dose of BOS. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for given categories. DXA was performed for participants aged 11-17 years only and no participants of this age range were present in PBO-BOS group. | Z-score | MEAN |
| PRIMARY | Change From Baseline in BMD For Adolescents Assessed by DXA Scan at Month 24 | Baseline, Month 24 | The safety set consisted of all participants who received at least 1 dose of BOS. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for given categories. DXA was performed for participants aged 11-17 years only and no participants of this age range were present in PBO-BOS group. | Z-score | MEAN |
| PRIMARY | Change From Baseline in BMD For Adolescents Assessed by DXA Scan at Month 36 | Baseline, Month 36 | The safety set consisted of all participants who received at least 1 dose of BOS. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for given categories. DXA was performed for participants aged 11-17 years only and no participants of this age range were present in PBO-BOS group. | Z-score | MEAN |
| PRIMARY | Change From Baseline in BMD For Adolescents Assessed by DXA Scan at Month 48 | Baseline, Month 48 | The safety set consisted of all participants who received at least 1 dose of BOS. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for given categories. DXA was performed for participants aged 11-17 years only and no participants of this age range were present in PBO-BOS group. | Z-score | MEAN |
| PRIMARY | Change From Baseline in BMD For Adolescents Assessed by DXA Scan at EOS (Up to Month 53) | Baseline, EOS (Up to Month 53) | The safety set consisted of all participants who received at least 1 dose of BOS. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for given categories. DXA was performed for participants aged 11-17 years only and no participants of this age range were present in PBO-BOS group. | Z-score | MEAN |
| PRIMARY | Change From Baseline in Cortisol Level After Adrenocorticotropic Hormone (ACTH) Stimulation at Month 12 | Baseline, Month 12 | The safety set consisted of all participants who received at least 1 dose of BOS. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for given categories. | micrograms per deciliter (mcg/dL) | MEAN |
| PRIMARY | Change From Baseline in Cortisol Level After ACTH Stimulation at Month 24 | Baseline, Month 24 | The safety set consisted of all participants who received at least 1 dose of BOS. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for given categories. | mcg/dL | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | BOS-BOS | TEAEs | 93 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | PBO-BOS | TEAEs | 7 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | BOS-BOS | Serious TEAEs | 11 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | PBO-BOS | Serious TEAEs | 0 | Participants | |
| Number of Participants With Clinically Significant Physical Examination Findings | BOS-BOS | Moon Face | 0 | Participants | |
| Number of Participants With Clinically Significant Physical Examination Findings | PBO-BOS | Moon Face | 0 | Participants | |
| Number of Participants With Clinically Significant Physical Examination Findings | BOS-BOS | Acne | 2 | Participants | |
| Number of Participants With Clinically Significant Physical Examination Findings | PBO-BOS | Acne | 0 | Participants | |
| Number of Participants With Clinically Significant Physical Examination Findings | BOS-BOS | Hirsutism | 0 | Participants | |
| Number of Participants With Clinically Significant Physical Examination Findings | PBO-BOS | Hirsutism | 0 | Participants |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BOS-BOS | 122 | |
| Overall Study | STARTED | PBO-BOS | 11 | |
| Overall Study | Treated | BOS-BOS | 121 | |
| Overall Study | Treated | PBO-BOS | 10 | |
| Overall Study | COMPLETED | BOS-BOS | 0 | |
| Overall Study | COMPLETED | PBO-BOS | 0 | |
| Overall Study | NOT COMPLETED | BOS-BOS | 122 | |
| Overall Study | NOT COMPLETED | PBO-BOS | 11 |
Source ClinicalTrials.gov
Adverse events88
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Mitral valve incompetence | Cardiac disorders | BOS-BOS | 0 | 121 | 0 |
| other | Mitral valve incompetence | Cardiac disorders | PBO-BOS | 1 | 10 | 1 |
| other | Tricuspid valve incompetence | Cardiac disorders | BOS-BOS | 0 | 121 | 0 |
| other | Tricuspid valve incompetence | Cardiac disorders | PBO-BOS | 1 | 10 | 1 |
| other | Dysphagia | Gastrointestinal disorders | BOS-BOS | 8 | 121 | 8 |
| other | Dysphagia | Gastrointestinal disorders | PBO-BOS | 0 | 10 | 0 |
| other | Nausea | Gastrointestinal disorders | BOS-BOS | 4 | 121 | 5 |
| other | Nausea | Gastrointestinal disorders | PBO-BOS | 1 | 10 | 1 |
| other | Oesophageal food impaction | Gastrointestinal disorders | BOS-BOS | 5 | 121 | 9 |
| other | Oesophageal food impaction | Gastrointestinal disorders | PBO-BOS | 1 | 10 | 1 |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BOS-BOS | 2 | 121 |
| Total, all-cause mortality | PBO-BOS | 0 | 10 |
| Total, other adverse events | BOS-BOS | 90 | 121 |
| Total, other adverse events | PBO-BOS | 7 | 10 |
| Total, serious adverse events | BOS-BOS | 11 | 121 |
| Total, serious adverse events | PBO-BOS | 0 | 10 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39954913 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| BOS-BOS vs PBO-BOS: Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Trial comparisons |
| BOS-BOS vs PBO-BOS: Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments | Trial comparisons |
| BOS-BOS vs PBO-BOS: deaths from any cause | Trial comparisons |
| BOS-BOS vs PBO-BOS: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03245840
GET https://conductscience.org/api/trials/v1/NCT03245840/results?page=2