Skip to content

Study · Non-randomized trial · 2010

4 results

Pasireotide (SOM230) demonstrates efficacy and safety in patients with acromegaly: a randomized, multicenter, phase II trial.

Petersenn S, Schopohl J, Barkan A, Mohideen P, Colao A, Abs R, Buchelt A, Ho YY, Hu K, Farrall AJ, Melmed S, Biller BM

The Journal of clinical endocrinology and metabolism21 Apr 2010Cited by 138 (Europe PMC)

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

  1. 01HumanNon-randomized trialEfficacy outcome

    In acromegaly, 19% achieved a biochemical response after 4 weeks of pasireotide.

    In plain wordsIn acromegaly, 19% achieved hormone control after 4 weeks of pasireotide.

    Outcome
    Not applicableBiochemical response after four weeks
    Study

    n: not reported in source

    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    200-600 microg twice daily · subcutaneous · 4 weeksAs given in this study (human).

    Measurements

    Biochemical response
    19%
    pasireotide 200-600 microg bid, 4 weeks

    Source sentences

    Summary
    After 4 wk of pasireotide 200-600 microg s.c. bid, 19% of patients achieved a biochemical response, which increased to 27% after 3 months of pasireotide; 39% of patients had a more than 20% reduction in pituitary tumor volume.
    4 context sentences
    Summary · context
    We conducted a phase II, randomized, multicenter, open-label, three-way, crossover study.
    Summary · context
    Sixty patients with acromegaly, defined by a 2-h five-point mean GH level higher than 5 microg/liter, lack of suppression of GH to less than 1 microg/liter after oral glucose tolerance test, and elevated IGF-I for age- and sex-matched controls.
    Summary · context
    After treatment with octreotide 100 microg s.c. three times daily for 28 d, each patient received pasireotide 200, 400, and 600 microg s.c. twice daily in random order for 28 d.
    Summary · context
    A biochemical response was defined as a reduction in GH to no more than 2.5 microg/liter and normalization of IGF-I to age- and sex-matched controls.
  2. 02HumanNon-randomized trialEfficacy outcome

    In acromegaly, biochemical response reached 27% after 3 months of pasireotide.

    In plain wordsIn acromegaly, 27% achieved hormone control after 3 months of pasireotide.

    Outcome
    Not applicableBiochemical response after three months
    Study

    n: not reported in source

    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    200-600 microg twice daily · subcutaneous · 3 monthsAs given in this study (human).

    Measurements

    Biochemical response
    27%
    pasireotide, 3 months

    Source sentences

    Summary
    After 4 wk of pasireotide 200-600 microg s.c. bid, 19% of patients achieved a biochemical response, which increased to 27% after 3 months of pasireotide; 39% of patients had a more than 20% reduction in pituitary tumor volume.
    4 context sentences
    Summary · context
    We conducted a phase II, randomized, multicenter, open-label, three-way, crossover study.
    Summary · context
    Sixty patients with acromegaly, defined by a 2-h five-point mean GH level higher than 5 microg/liter, lack of suppression of GH to less than 1 microg/liter after oral glucose tolerance test, and elevated IGF-I for age- and sex-matched controls.
    Summary · context
    After treatment with octreotide 100 microg s.c. three times daily for 28 d, each patient received pasireotide 200, 400, and 600 microg s.c. twice daily in random order for 28 d.
    Summary · context
    A biochemical response was defined as a reduction in GH to no more than 2.5 microg/liter and normalization of IGF-I to age- and sex-matched controls.
  3. 03HumanNon-randomized trialEfficacy outcome

    In acromegaly, 39% of pasireotide-treated patients had a >20% reduction in pituitary tumor volume.

    In plain wordsIn acromegaly, 39% of pasireotide-treated patients had a pituitary tumor volume reduction greater than 20%.

    Outcome
    DecreasePituitary tumor volume reduction
    Study

    n: not reported in source

    Comparator
    Baseline
    Outcome group
    Tumor growth · Endocrine and hormones
    Studied dose
    200-600 microg twice daily · subcutaneousAs given in this study (human).

    Measurements

    Patients with pituitary tumor volume reduction >20%
    39%
    pasireotide

    Source sentences

    Summary
    After 4 wk of pasireotide 200-600 microg s.c. bid, 19% of patients achieved a biochemical response, which increased to 27% after 3 months of pasireotide; 39% of patients had a more than 20% reduction in pituitary tumor volume.
    4 context sentences
    Summary · context
    We conducted a phase II, randomized, multicenter, open-label, three-way, crossover study.
    Summary · context
    Sixty patients with acromegaly, defined by a 2-h five-point mean GH level higher than 5 microg/liter, lack of suppression of GH to less than 1 microg/liter after oral glucose tolerance test, and elevated IGF-I for age- and sex-matched controls.
    Summary · context
    After treatment with octreotide 100 microg s.c. three times daily for 28 d, each patient received pasireotide 200, 400, and 600 microg s.c. twice daily in random order for 28 d.
    Summary · context
    A biochemical response was defined as a reduction in GH to no more than 2.5 microg/liter and normalization of IGF-I to age- and sex-matched controls.
  4. 04HumanNon-randomized trialSafety outcome

    In acromegaly, pasireotide was generally well tolerated.

    In plain wordsIn acromegaly, patients generally tolerated pasireotide well.

    Outcome
    Not applicableTolerability
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    200-600 microg twice daily · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Pasireotide was generally well tolerated.
    4 context sentences
    Summary · context
    We conducted a phase II, randomized, multicenter, open-label, three-way, crossover study.
    Summary · context
    Sixty patients with acromegaly, defined by a 2-h five-point mean GH level higher than 5 microg/liter, lack of suppression of GH to less than 1 microg/liter after oral glucose tolerance test, and elevated IGF-I for age- and sex-matched controls.
    Summary · context
    After treatment with octreotide 100 microg s.c. three times daily for 28 d, each patient received pasireotide 200, 400, and 600 microg s.c. twice daily in random order for 28 d.
    Summary · context
    A biochemical response was defined as a reduction in GH to no more than 2.5 microg/liter and normalization of IGF-I to age- and sex-matched controls.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2NCT00088582

Study Comparing SOM230 Subcutaneously and Sandostatin Subcutaneously in Acromegalic Patients

Novartis Pharmaceuticalsn = 62Mar 2004 to Oct 2005 (primary)

Acromegaly

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 3Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 2

    27 Oct 2026, 16:36 UTC

    Study data updated · source update from Europe PMC

  3. Version 1

    27 Oct 2026, 16:34 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

PepBank is a research reference. Talk to a doctor before you use any peptide.