Clinical trial NCT00372697: Efficacy/Safety of Octreotide Acetate in Patients With Uncontrolled Acromegaly
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acromegaly
Keywords: acromegaly
octreotide acetate
partial responder patients
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-09-07
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluated the safety and efficacy of an increased frequency of octreotide acetate injections or an increase in dose in partially responsive acromegalic patients with persistently uncontrolled disease.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Growth Hormone (GH) Level From Screening to End of Study (Week 24)
timeFrame: Screening to end of study (Week 24)
measure: Change in Insulin-like Growth Factor 1 (IGF-1) Level From Screening to End of Study (Week 24)
timeFrame: Screening to end of study (Week 24)
Secondary outcomes:
measure: Change in Tumor Volume From Screening to End of Study (Week 24)
timeFrame: Screening to end of study (Week 24)
measure: Percentage of Participants With > 20% Tumor Shrinkage From Screening to End of Study (Week 24)
timeFrame: Screening to end of study (Week 24)
measure: Percentage of Participants Asymptomatic for Acromegaly Symptoms at Week 12 and End of Study (Week 24)
timeFrame: Week 12 and end of study (Week 24)
measure: Acromegaly Quality of Life (AcroQoL) Questionnaire Physical Scale Score at End of Study (Week 24)
timeFrame: End of study (Week 24)
measure: Acromegaly Quality of Life (AcroQoL) Questionnaire Psychological Scale Score at End of Study (Week 24)
timeFrame: End of study (Week 24)
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_CHAIR
References:
citation: Mazziotti G, Porcelli T, Bogazzi F, Bugari G, Cannavo S, Colao A, Cozzi R, De Marinis L, degli Uberti E, Grottoli S, Minuto F, Montini M, Spinello M, Giustina A. Effects of high-dose octreotide LAR on glucose metabolism in patients with acromegaly inadequately controlled by conventional somatostatin analog therapy. Eur J Endocrinol. 2011 Mar;164(3):341-7. doi: 10.1530/EJE-10-0811. Epub 2011 Jan 6.