Acromegaly due to GH-secreting hypophysial adenoma, persistent after surgical adenomectomy, external radiotherapy or medical therapy with analogous of somatostatin. MedDRA version: 9.1 Level: LLT Classification code 10000599 Term: Acromegaly
Conditions
Interventions
Trade Name: AVANDIA*28CPR RIV 4MG
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Rosiglitazone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-
Sponsors
AZIENDA OSPEDALIERA PISANA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a.Male and/or female subjects, 20 years =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a.Patients with age 70 years; b.Patients with cardiac insufficiency or history of cardiac insufficiency (classes NYHA I-IV); c.Patients with diabetes mellitus treated with insulin; d.Patients with hypersensitivity to rosiglitazone or to the excipients of the tablet; e. Patients with hepatic insufficiency; f.Patients with renal insufficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety assessment of rosiglitazone at higher dose than the ones provided by the technical form, in 5 patients with active acromegaly or resistant to conventional treatments.;Secondary Objective: Assessment of reduction of the biochemical parameters of disease's activity (serum concentrations of GH and IGF-1) in 5 patients with active acromegaly or resistant to conventional treatments.;Primary end point(s): Objective analysis, including the measurement of corporeal weight, cardiac frequency and arterial pressure; laboratory analysis: hemochromo, examination of hepatic fuctionality, renal fuctionality, glycaemia, insulinemia, lipidic profile, total proteins, protein electrophoresis, plasmatic electrolytes, standard test of the urine. | — |
Countries
Italy
Outcome results
None listed