Efficacy/Safety of Octreotide Acetate in Patients With Uncontrolled Acromegaly

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00372697
First received: September 6, 2006
Last updated: April 19, 2011
Last verified: April 2011

September 6, 2006
April 19, 2011
December 2005
October 2007   (final data collection date for primary outcome measure)
  • Change in Growth Hormone (GH) Level From Screening to End of Study (Week 24) [ Time Frame: Screening to end of study (Week 24) ] [ Designated as safety issue: No ]
    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.
  • Change in Insulin-like Growth Factor 1 (IGF-1) Level From Screening to End of Study (Week 24) [ Time Frame: Screening to end of study (Week 24) ] [ Designated as safety issue: No ]
    Insulin-like growth factor 1 (IGF-1) level was measured in a blood sample with an automated immunometric assay in a central laboratory.
Not Provided
Complete list of historical versions of study NCT00372697 on ClinicalTrials.gov Archive Site
  • Change in Tumor Volume From Screening to End of Study (Week 24) [ Time Frame: Screening to end of study (Week 24) ] [ Designated as safety issue: Yes ]
    A pre-treatment magnetic resonance image (MRI) assessment of the pituitary area was required within 12 weeks prior to Screening as a baseline evaluation. A second MRI was performed at the end of the study (Week 24). All MRIs were performed according to protocol-defined guidelines. The tumor volume (mm^3) was calculated from measurements obtained in 3 axes from the MRI images.
  • Percentage of Participants With > 20% Tumor Shrinkage From Screening to End of Study (Week 24) [ Time Frame: Screening to end of study (Week 24) ] [ Designated as safety issue: Yes ]
    A pre-treatment magnetic resonance image (MRI) assessment of the pituitary area was required within 12 weeks prior to Screening as a baseline evaluation. A second MRI was performed at the end of the study (Week 24). All MRIs were performed according to protocol-defined guidelines. The tumor volume (mm^3) was calculated from measurements obtained in 3 axes from the MRI images.
  • Percentage of Participants Asymptomatic for Acromegaly Symptoms at Week 12 and End of Study (Week 24) [ Time Frame: Week 12 and end of study (Week 24) ] [ Designated as safety issue: Yes ]
    The investigator asked the participant to score the following symptoms of acromegaly: Headache, perspiration, paresthesia, fatigue, osteoarthralgia, and carpal tunnel syndrome on a 5-point scale (0=absent; 1=mild; 2=moderate; 3=severe, but not disabling; 4=severe and disabling). The percentage of asymptomatic participants, ie, with a score of 0 for all symptoms, was calculated.
  • Acromegaly Quality of Life (AcroQoL) Questionnaire Physical Scale Score at End of Study (Week 24) [ Time Frame: End of study (Week 24) ] [ Designated as safety issue: Yes ]
    The AcroQoL contains 8 items on Physical aspects. Participants were asked to rate each item on a 1-5 Likert scale measuring either the frequency of occurrence (always, most of the time, sometimes, rarely, or never) or the degree of agreement (completely agree, moderately agree, neither agree nor disagree, moderately disagree, completely disagree). The score on the physical scale can range from 8-40. A higher score indicates better Quality of Life.
  • Acromegaly Quality of Life (AcroQoL) Questionnaire Psychological Scale Score at End of Study (Week 24) [ Time Frame: End of study (Week 24) ] [ Designated as safety issue: Yes ]
    The AcroQoL contains 14 items on Psychological aspects. Participants were asked to rate each item on a 1-5 Likert scale measuring either the frequency of occurrence (always, most of the time, sometimes, rarely, or never) or the degree of agreement (completely agree, moderately agree, neither agree nor disagree, moderately disagree, completely disagree). The score on the psychological scale ranges from 14-70. A higher score indicates better Quality of Life.
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Efficacy/Safety of Octreotide Acetate in Patients With Uncontrolled Acromegaly
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acromegaly
Drug: Octreotide acetate 30 mg suspension
Each vial of study medication contained octreotide acetate 30 mg in a microencapsulated biodegradable polymer, poly (DL-lactide-co-glycolide) (D-(+)glucose), with 17% w/w mannitol in an approximate octreotide:polymer ratio of 1:20. The vehicle contained 0.5% sodium carboxymethylcellulose.
Other Name: Sandostatin LAR
  • Experimental: Octreotide 30 mg every 21 days
    Patients received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
    Intervention: Drug: Octreotide acetate 30 mg suspension
  • Experimental: Octreotide 60 mg every 28 days
    Patients received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
    Intervention: Drug: Octreotide acetate 30 mg suspension
Mazziotti G, Porcelli T, Bogazzi F, Bugari G, Cannavò 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
October 2007
October 2007   (final data collection date for primary outcome measure)

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.

Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00372697
CSMS995BIT12
Not Provided
External Affairs, Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Chair: Novartis Novartis
Novartis
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP