WHO ICTRP trial
Study that aims to determine whether the switch from the existing composition of…
EUCTR2012-005732-28-BE · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2012-005732-28-BE |
|---|---|
| Public title | Study that aims to determine whether the switch from the existing composition of L-Thyroxine Christiaens® tablets to a new composition necessitates a dose adjustment in patients who underwent an (almost) total surgical removal of their thyroid gland. |
| Scientific title | A multicentre, open-label switch study to investigate the necessity of dose adjustment after switching from L-Thyroxine Christiaens® to the new levothyroxine sodium test formulation in (near) total thyroidectomised patients. |
| Primary sponsor | Takeda Belgium |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | Belgium |
| Conditions | Patient that underwent a near total thyroidectomy and therefore are compelled to take levothyroxine hormone substition therapy. MedDRA version: 16.0 Level: LLT Classification code 10043777 Term: Thyroidectomy total System Organ Class… |
| Interventions | Trade Name: L-Thyroxine Christiaens Product Name: levothyroxine test formulation Pharmaceutical Form: Tablet INN or Proposed INN: LEVOTHYROXINE SODIUM CAS Number: 55-03-8 Concentration unit: µg microgram(s) Concentration type: equal… |
| Registration date | Apr 29, 2013 |
| Target size | 90 |
| Secondary IDs | LE-9999-401-BE |
| Registry page | clinicaltrialsregister.eu |
At a glance
- Yes Results available
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: