Trial abstract · §2
TED-PAEDIATRIC — design and population
Design, allocation, arms and the population enrolled.
§2Design and population
§2.1Design and allocation
- Design class
- Single-arm open-label study
- Masking
- None
- Arms
- 1
- Allocation
- Single arm; no randomisation
- Endpoint adjudication
- Not applicable to the primary endpoint of this design
- Data monitoring
- As specified in the protocol
§2.2Arms
Table 2. Randomised arms. Illustrative: arm-level allocations are reconstructed by the Institute from the design class and the randomised total where the published report does not state them.
| Arm | Allocated | Share | Description |
|---|---|---|---|
| Teduglutide | 59 | 100.0 % | Open-label active treatment; no randomised comparator |
| Randomised total 59 as published. Arm-level splits are reconstructed and are not published figures. | |||
§2.3Population
Indication. Inflammatory bowel disease and mucosal barrier disorders
Chronic immune-mediated inflammation of the intestinal tract, or disorders of intestinal permeability including coeliac disease.
Geographic footprint. United States · Germany · Denmark · South Africa.
§2.4Eligibility as the Institute reads it
- Included. Chronic immune-mediated inflammation of the intestinal tract, or disorders of intestinal permeability including coeliac disease.
- Excluded. Participants for whom the intervention is contraindicated, including active gastrointestinal malignancy. Exclusion criteria narrow the population to which the estimate applies and are the principal source of indirectness where a trial estimate is applied to ordinary practice.
Compound Evidence Institute · CEI-TR-0154/2 · https://compoundevidence.com/trials/ted-paediatric/design/ · retrieved 30 July 2026