Back to resultsEfficacy/Safety of Octreotide Acetate in Patients With Uncontrolled Acromegaly
Primary Purpose
Acromegaly
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Octreotide acetate 30 mg suspension
Sponsored by
About this trial
This is an interventional treatment trial for Acromegaly focused on measuring acromegaly, octreotide acetate, partial responder patients
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.
Sites / Locations
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Octreotide 30 mg every 21 days
Octreotide 60 mg every 28 days
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in Growth Hormone (GH) Level From Screening to End of Study (Week 24)
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)
Insulin-like growth factor 1 (IGF-1) level was measured in a blood sample with an automated immunometric assay in a central laboratory.
Secondary Outcome Measures
Change in Tumor Volume From Screening to End of Study (Week 24)
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)
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)
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)
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)
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.
Full Information
NCT ID
NCT00372697
First Posted
September 6, 2006
Last Updated
April 19, 2011
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00372697
Brief Title
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
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly
Keywords
acromegaly, octreotide acetate, partial responder patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Octreotide 30 mg every 21 days
Arm Type
Experimental
Arm Description
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.
Arm Title
Octreotide 60 mg every 28 days
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Octreotide acetate 30 mg suspension
Other Intervention Name(s)
Sandostatin LAR
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Growth Hormone (GH) Level From Screening to End of Study (Week 24)
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.
Time Frame
Screening to end of study (Week 24)
Title
Change in Insulin-like Growth Factor 1 (IGF-1) Level From Screening to End of Study (Week 24)
Description
Insulin-like growth factor 1 (IGF-1) level was measured in a blood sample with an automated immunometric assay in a central laboratory.
Time Frame
Screening to end of study (Week 24)
Secondary Outcome Measure Information:
Title
Change in Tumor Volume From Screening to End of Study (Week 24)
Description
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.
Time Frame
Screening to end of study (Week 24)
Title
Percentage of Participants With > 20% Tumor Shrinkage From Screening to End of Study (Week 24)
Description
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.
Time Frame
Screening to end of study (Week 24)
Title
Percentage of Participants Asymptomatic for Acromegaly Symptoms at Week 12 and End of Study (Week 24)
Description
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.
Time Frame
Week 12 and end of study (Week 24)
Title
Acromegaly Quality of Life (AcroQoL) Questionnaire Physical Scale Score at End of Study (Week 24)
Description
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.
Time Frame
End of study (Week 24)
Title
Acromegaly Quality of Life (AcroQoL) Questionnaire Psychological Scale Score at End of Study (Week 24)
Description
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.
Time Frame
End of study (Week 24)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis Investigative Site
City
Brescia
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
21212103
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.
Results Reference
derived
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Efficacy/Safety of Octreotide Acetate in Patients With Uncontrolled Acromegaly
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