Quality of life related to recombinant TSH treatment compared to

Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2007
INTERVENTION: Trade Name: thyrogen Product Name: thyrogen Pharmaceutical Form: Injection* Other descriptive name: THYROTROPIN ALFA Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0,9‐ Pharmaceutical form of the placebo: Injection* Route of administration of the placebo: Intramuscular use Trade Name: Liothyronin Product Name: Liothyronin Pharmaceutical Form: Tablet INN or Proposed INN: LIOTHYRONINE CAS Number: 550618 Concentration unit: µg microgram(s) Concentration number: 20‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Enteral use (Noncurrent) CONDITION: in patients with thyroid cancer (follicular or papillary), injektion with recombinant TSH to increase s‐TSH before iodine uptake to detect remaining cancer og recurrence of cancer in patients surgecal treated thyroid cancer ; MedDRA version: 9.1 Level: LLT Classification code 10033701 Term: Papillary thyroid cancer ; MedDRA version: 9.1 Level: LLT Classification code 10016935 Term: Follicular thyroid cancer PRIMARY OUTCOME: Main Objective: Quality of life related to recombinant TSH treatment compared to ; no treatment related to iodine uptake, in patient with thyroid cancer (follikcular, papillary).; A double blinded, randomized crossover study.; Primary end point(s): quality of life evaluated with VAS, SF‐ 36, Eorts QLC 30 Secondary Objective: INCLUSION CRITERIA: Patients, surgery treated for thyroid cancer, follicular og papillary. age 18‐75yaer Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Epistemonikos ID: 53a104984a2d51850812fed01aedbcad246b3927
First added on: Aug 21, 2024