Primary outcomeMean· Screening to end of study (Week 24)
Change in Growth Hormone (GH) Level From Screening to End of Study (Week 24)
| Group | Value (µg/L) | Spread |
|---|---|---|
| Octreotide 30 mg Every 21 Days | -1.7 | 9.9 |
| Octreotide 60 mg Every 28 Days | -2.1 | 3.6 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataEfficacy/Safety of Octreotide Acetate in Patients With Uncontrolled Acromegaly
NCTNCT00372697 (opens ClinicalTrials.gov in a new tab)Other idCSMS995BIT12
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 28 participants (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Design
- Randomized · Open label (no masking)
- Countries
1 country
Italy
- Start
- Dec 2005
- Primary completion
- Oct 2007
- Completion
- Oct 2007
- First posted
- 7 Sept 2006 (estimated)
- Last update posted
- 17 May 2011 (estimated)
- Conditions
- Acromegaly
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2005200620072008
- Ph 3
Efficacy/Safety of Octreotide Acetate in Patients With Uncontrolled Acromegaly
NCT00372697Dec 2005 to Oct 2007
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Octreotide acetate 30 mg suspensionDrug
Arms2
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.
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.
Primary outcomes2
Outcomes the sponsor listed as primary.
Change in Growth Hormone (GH) Level From Screening to End of Study (Week 24)
Time frame · Screening to end of study (Week 24)
Registry 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.
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)
Registry description
Insulin-like growth factor 1 (IGF-1) level was measured in a blood sample with an automated immunometric assay in a central laboratory.
Secondary outcomes(5)
Change in Tumor Volume From Screening to End of Study (Week 24)
Time frame · Screening to end of study (Week 24)
Registry 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.
Percentage of Participants With > 20% Tumor Shrinkage From Screening to End of Study (Week 24)
Time frame · Screening to end of study (Week 24)
Registry 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.
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)
Registry 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.
Acromegaly Quality of Life (AcroQoL) Questionnaire Physical Scale Score at End of Study (Week 24)
Time frame · End of study (Week 24)
Registry 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.
Acromegaly Quality of Life (AcroQoL) Questionnaire Psychological Scale Score at End of Study (Week 24)
Time frame · End of study (Week 24)
Registry 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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeMean· Screening to end of study (Week 24)
Change in Insulin-like Growth Factor 1 (IGF-1) Level From Screening to End of Study (Week 24)
| Group | Value (µg/L) | Spread |
|---|---|---|
| Octreotide 30 mg Every 21 Days | -40.4 | 180.2 |
| Octreotide 60 mg Every 28 Days | -135.0 | 170.9 |
Secondary and other outcome results(5)
Secondary outcomeMean· Screening to end of study (Week 24)
Change in Tumor Volume From Screening to End of Study (Week 24)
| Group | Value (mm^3) | Spread |
|---|---|---|
| Octreotide 30 mg Every 21 Days | 15.9 | 91.8 |
| Octreotide 60 mg Every 28 Days | -0.4 | 21.0 |
Secondary outcomeNumber· Screening to end of study (Week 24)
Percentage of Participants With > 20% Tumor Shrinkage From Screening to End of Study (Week 24)
| Group | Value (Percentage of participants) | Spread |
|---|---|---|
| Octreotide 30 mg Every 21 Days | 14.3 | 6426 |
| Octreotide 60 mg Every 28 Days | 11.1 | 4211 |
Secondary outcomeNumber· Week 12 and end of study (Week 24)
Percentage of Participants Asymptomatic for Acromegaly Symptoms at Week 12 and End of Study (Week 24)
| Group | Value (Percentage of participants) |
|---|---|
| Octreotide 30 mg Every 21 Days | 33.3 |
| Octreotide 60 mg Every 28 Days | 9.09 |
Secondary outcomeMean· End of study (Week 24)
Acromegaly Quality of Life (AcroQoL) Questionnaire Physical Scale Score at End of Study (Week 24)
| Group | Value (Percent of maximum score) | Spread |
|---|---|---|
| Octreotide 30 mg Every 21 Days | 67.9 | 22.6 |
| Octreotide 60 mg Every 28 Days | 58.0 | 21.8 |
Secondary outcomeMean· End of study (Week 24)
Acromegaly Quality of Life (AcroQoL) Questionnaire Psychological Scale Score at End of Study (Week 24)
| Group | Value (Percent of maximum score) | Spread |
|---|---|---|
| Octreotide 30 mg Every 21 Days | 65.1 | 19.9 |
| Octreotide 60 mg Every 28 Days | 72.1 | 19.6 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Octreotide 30 mg Every 21 DaysParticipants 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. | – | 0 / 16 | 3 / 16 |
| Octreotide 60 mg Every 28 DaysParticipants 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. | – | 0 / 12 | 2 / 12 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
More studies
1 study on this page
Indexing hint: Randomized controlled trial · 2011
Effects of high-dose octreotide LAR on glucose metabolism in patients with acromegaly inadequately controlled by conventional somatostatin analog therapy.
Mazziotti et al. 2011European journal of endocrinologycited by 44
PMID 21212103DOI 10.1530/eje-10-0811PUB-21212103
Rights unknown
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 80 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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.
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