Trial · NCT02720952
Treatment of Adrenal Insufficiency in Children
NCT02720952, Phase 3, Completed, Neurocrine UK Limited; results first posted 2017-04-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment of Adrenal Insufficiency in Children. Trials, record NCT02720952. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02720952
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Adrenal Insufficiency in Children
- NCT number
- NCT02720952
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 24 participants, actual
- Lead sponsor
- Neurocrine UK Limited
- Conditions
- Adrenal Insufficiency
- Interventions
- Infacort®
- First posted
- 2016-03-28
- Last updated
- 2026-10-02
- Results first posted
- 2017-04-11
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Serum Cortisol Concentration up to 240 Minutes | 240 minutes | The primary endpoint will be the maximum levels of serum cortisol concentration up to 240 minutes after intake of study drug as determined by the central laboratory. |
| Secondary | Serum Cortisol Concentration up to 6 Hours | 240 minutes | Serum cortisol concentration 240 minutes after intake of study drug as determined by the central laboratory |
| Secondary | Subject Assessment of Taste of the Product | 1 minute | Palatability of the investigational product as determined by parent/carer responses to the following questions: Question 1: My child found swallowing easy. Question 2: My child showed a positive reaction after Infacort was given. Question 3: I would be happy to give my child Infacort in the future. Question 4: Overall, I would prefer Infacort for my child over the usual hydrocortisone medication. |
| Secondary | Incidence of Serious Adverse Events (SAEs) and Adverse Events (AE) | 7-10 days | Incidence of serious adverse events (SAEs) and adverse events (AE). |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Serum Cortisol Concentration up to 240 Minutes | 240 minutes | nmol/L | GEOMETRIC_MEAN | |
| SECONDARY | Serum Cortisol Concentration up to 6 Hours | 240 minutes | nmol/L | GEOMETRIC_MEAN | |
| SECONDARY | Subject Assessment of Taste of the Product | 1 minute | Out of the total population, one parent/carer did not complete the palatability questionnaire and one parent/carer did not complete questions 3 and 4, and thus were excluded from the analysis of the relevant questions. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of Serious Adverse Events (SAEs) and Adverse Events (AE) | 7-10 days | Adverse Events | NUMBER |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Serum Cortisol Concentration up to 240 Minutes | Infacort | 575.8 | Geometric Coefficient of Variation 47.9 | nmol/L | |
| Serum Cortisol Concentration up to 6 Hours | Infacort | 60.1 | Geometric Coefficient of Variation 131.7 | nmol/L | |
| Subject Assessment of Taste of the Product | Question 1 | 19 | Participants | ||
| Subject Assessment of Taste of the Product | Question 2 | 15 | Participants | ||
| Subject Assessment of Taste of the Product | Question 3 | 21 | Participants | ||
| Subject Assessment of Taste of the Product | Question 4 | 21 | Participants | ||
| Incidence of Serious Adverse Events (SAEs) and Adverse Events (AE) | Infacort | Treatment-Emergent | 12 | Adverse Events | |
| Incidence of Serious Adverse Events (SAEs) and Adverse Events (AE) | Infacort | Serious TEAEs | 0 | Adverse Events | |
| Incidence of Serious Adverse Events (SAEs) and Adverse Events (AE) | Infacort | Severe TEAEs | 0 | Adverse Events | |
| Incidence of Serious Adverse Events (SAEs) and Adverse Events (AE) | Infacort | Moderate TEAEs | 2 | Adverse Events |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Infacort | 24 | |
| Overall Study | COMPLETED | Infacort | 24 | |
| Overall Study | NOT COMPLETED | Infacort | 0 |
Source ClinicalTrials.gov
Adverse events6
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 | Diarrhoea | Gastrointestinal disorders | Infacort | 3 | 24 | 3 |
| other | Vomiting | Gastrointestinal disorders | Infacort | 2 | 24 | 2 |
| other | Infantile spitting up | Gastrointestinal disorders | Infacort | 1 | 24 | 2 |
| other | Rash | Skin and subcutaneous tissue disorders | Infacort | 2 | 24 | 2 |
| other | Hyperhidrosis | Skin and subcutaneous tissue disorders | Infacort | 1 | 24 | 2 |
| other | Fatigue | General disorders | Infacort | 1 | 24 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Infacort | 0 | 24 |
| Total, other adverse events | Infacort | 8 | 24 |
| Total, serious adverse events | Infacort | 0 | 24 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02720952
GET https://conductscience.org/api/trials/v1/NCT02720952/registered