Phase 3
N=28
Efficacy/Safety of Octreotide Acetate in Patients With Uncontrolled Acromegaly
Acromegaly
Bottom Line
View on ClinicalTrials.gov: NCT00372697 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
May 2011
Primary outcome: Primary: Change in Growth Hormone (GH) Level From Screening to End of Study (Week 24) — -1.7; -2.1 µg/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Octreotide acetate 30 mg suspension (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Oct 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Growth Hormone (GH) Level From Screening to End of Study (Week 24) |
-1.7; -2.1 | — |
| PRIMARY Change in Insulin-like Growth Factor 1 (IGF-1) Level From Screening to End of Study (Week 24) |
-40.4; -135.0 | — |
| SECONDARY Change in Tumor Volume From Screening to End of Study (Week 24) |
15.9; -0.4 | — |
| SECONDARY Percentage of Participants With > 20% Tumor Shrinkage From Screening to End of Study (Week 24) |
14.3; 11.1 | — |
| SECONDARY Percentage of Participants Asymptomatic for Acromegaly Symptoms at Week 12 and End of Study (Week 24) |
33.3; 9.09; 20.0; 9.09 | — |
| SECONDARY Acromegaly Quality of Life (AcroQoL) Questionnaire Physical Scale Score at End of Study (Week 24) |
67.9; 58.0 | — |
| SECONDARY Acromegaly Quality of Life (AcroQoL) Questionnaire Psychological Scale Score at End of Study (Week 24) |
65.1; 72.1 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00372697). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.