Know Cancer

or
forgot password

A Randomised, Open-label, Multicenter Study Comparing the Efficacy and Safety of Medical Treatment With Octreotide Acetate 30 mg Administered Every 21 Days for 6 Months With That of Octreotide Acetate 60 mg Administered Every 28 Days for 6 Months in Acromegalic Patients With Uncontrolled Disease


Phase 3
18 Years
80 Years
Not Enrolling
Both
Acromegaly

Thank you

Trial Information

A Randomised, Open-label, Multicenter Study Comparing the Efficacy and Safety of Medical Treatment With Octreotide Acetate 30 mg Administered Every 21 Days for 6 Months With That of Octreotide Acetate 60 mg Administered Every 28 Days for 6 Months in Acromegalic Patients With Uncontrolled Disease


Inclusion Criteria:



- Written voluntary informed consent.

- Patients with biochemically documented active acromegaly who are currently receiving
somatostatin-analogues in a conventional treatment regimen (octreotide up to 30 mg/28
days; lanreotide up to 120 mg/28 days) for at least 6 months.

- Patients with uncontrolled disease defined as patients with a decrease of baseline
levels of growth hormone (GH) ≥ 50% during treatment with somatostatin-analogues in a
conventional regimen (sandostatin up to 30 mg/28 days; lanreotide up to 120 mg/28
days) for at least 6 months.

- Baseline (mean of 3 samples) GH level > 2 µg/L.

- Insulin-like Growth Factor I (IGF-I) levels above the upper limits of normal for age
and gender.

Other protocol-defined inclusion/exclusion criteria applied to the study.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change in Growth Hormone (GH) Level From Screening to End of Study (Week 24)

Outcome Description:

Growth hormone (GH) level was the average value measured in 3 blood samples collected at 15 minute intervals at each visit. GH was measured with an automated immunometric assay in a central laboratory.

Outcome Time Frame:

Screening to end of study (Week 24)

Safety Issue:

No

Principal Investigator

Novartis

Investigator Role:

Study Chair

Investigator Affiliation:

Novartis

Authority:

Italy: Ethic Committee of Ospedali Civili di Brescia on behalf of National Health Authority

Study ID:

CSMS995BIT12

NCT ID:

NCT00372697

Start Date:

December 2005

Completion Date:

October 2007

Related Keywords:

  • Acromegaly
  • acromegaly
  • octreotide acetate
  • partial responder patients
  • Acromegaly

Name

Location