AcromegalyPhase 2NCT00088582
Study Comparing SOM230 Subcutaneously and Sandostatin Subcutaneously in Acromegalic Patients
A Phase 2 study testing Pasireotide (SOM230), Octreotide (Sandostatin) in people with Acromegaly, run by Novartis Pharmaceuticals at 5 sites in United States.
Trial summary
5 month study comparing SOM230 s.c. and Sandostatin s.c. in acromegalic patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acromegaly
- What is being tested?
- Pasireotide (SOM230), Octreotide (Sandostatin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2004to Oct 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with active acromegaly due to a pituitary adenoma
- Patients who have been previously treated for acromegaly with certain medications may be required to be without certain medications prior to entering the study
Who cannot join
- Patients with compression of the optic chiasm causing any visual field defect
- Patients who require a surgical intervention for relief of any sign or symptom associated with tumor compression
- Patients who have received radiotherapy in the 2 years prior to the start of the trial
- Patients who have congestive heart failure, unstable angina, cardia arrhythmia, or a history of acute myocardial infarction within the three months preceding enrollment
- Patients with gallstone disease
- Patients with chronic liver disease
Show all 11Show fewer
- Known hypersensitivity to Sandostatin or Sandostatin LAR
- Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control and highly effective method for birth control
- History of immunocompromise, including a positive HIV test result
- Patients who have a history of alcohol or drug abuse in the six-month period prior to the enrollment visit
- Patients who have participated in any clinical investigation with an investigational drug within 4 weeks prior to dosing
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Michigan Medical Center
Ann Arbor, Michigan, 48108
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Virginia Health System
Charlottesville, Virginia, 22908
Cedars Sinai Medical Center
Los Angeles, California, 90048
New York University/VA Medical Center
New York, New York, 10010
About this study
Official title: A Multicenter, Randomized, Crossover, Open Label Dose Finding Study to Compare the Safety, Efficacy and PK/PD Relationship of Multiple Doses of SOM230 and Sandostatin in Acromegalic Patients
5 month study comparing SOM230 s.c. and Sandostatin s.c. in acromegalic patients.
- Conditions
- Acromegaly
- Being tested
- Pasireotide (SOM230), Octreotide (Sandostatin)
- Keywords
- Acromegaly, SOM230, Sandostatin
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pasireotide (SOM230), Octreotide (Sandostatin)Drug
| Study group | Role | What they receive |
|---|---|---|
| Sandostatin s.c. (Octreotide) | Experimental | Not described Receives: Drug: Pasireotide (SOM230), Octreotide (Sandostatin) |
| Pasireotide (SOM230) | Experimental | Not described Receives: Drug: Pasireotide (SOM230), Octreotide (Sandostatin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating GH- and IGF-1 concentrations measured every 2 weeks
Measured: 6 months
Secondary outcomes (1)
Safety and efficacy of multiple doses of Pasireotide s.c. and Sandostatin s.c.
Measured: Every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2004 (estimated)
- Study startMar 2004
- Primary completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00088582
- Sponsor's protocol ID
- CSOM230B2201
- Status last verified
- Nov 2016
- First submitted
- 30 Jul 2004
- Last updated
- 7 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Petersenn S, Schopohl J, Barkan A, Mohideen P, Colao A, Abs R, Buchelt A, Ho YY, Hu K, Farrall AJ, Melmed S, Biller BM; Pasireotide Acromegaly Study Group. Pasireotide (SOM230) demonstrates efficacy and safety in patients with acromegaly: a randomized, multicenter, phase II trial. J Clin Endocrinol Metab. 2010 Jun;95(6):2781-9. doi: 10.1210/jc.2009-2272. Epub 2010 Apr 21.
PubMed 20410233
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Crossover, Open Label Dose Finding Study to Compare the Safety, Efficacy and PK/PD Relationship of Multiple Doses of SOM230 and Sandostatin in Acromegalic Patients
- ClinicalTrials.gov ID
- NCT00088582
- Acronym / sponsor ID
- CSOM230B2201
- Conditions
- Acromegaly
- Keywords
- Acromegaly, SOM230, Sandostatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Primary completion
- Oct 2005 (actual)
- First posted
- 2 Aug 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
5 month study comparing SOM230 s.c. and Sandostatin s.c. in acromegalic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sandostatin s.c. (Octreotide) | Experimental | Drug: Pasireotide (SOM230), Octreotide (Sandostatin) |
| Pasireotide (SOM230) | Experimental | Drug: Pasireotide (SOM230), Octreotide (Sandostatin) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with active acromegaly due to a pituitary adenoma
- Patients who have been previously treated for acromegaly with certain medications may be required to be without certain medications prior to entering the study
Key exclusion criteria (11 listed)
- Patients with compression of the optic chiasm causing any visual field defect
- Patients who require a surgical intervention for relief of any sign or symptom associated with tumor compression
- Patients who have received radiotherapy in the 2 years prior to the start of the trial
- Patients who have congestive heart failure, unstable angina, cardia arrhythmia, or a history of acute myocardial infarction within the three months preceding enrollment
- Patients with gallstone disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pasireotide (SOM230), Octreotide (Sandostatin) | Drug | Pasireotide (SOM230), Sandostatin s.c. (Octreotide) |
Primary outcome
Circulating GH- and IGF-1 concentrations measured every 2 weeks
Time frame: 6 months
1 secondary outcome
Safety and efficacy of multiple doses of Pasireotide s.c. and Sandostatin s.c.
Time frame: Every 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2016.
- Results publication: PubMed 20410233Petersenn S, Schopohl J, Barkan A, Mohideen P, Colao A, Abs R, Buchelt A, Ho YY, Hu K, Farrall AJ, Melmed S, Biller BM; Pasireotide Acromegaly Study Group. Pasireotide (SOM230) demonstrates efficacy and safety in patients with acromegaly: a randomized, multicenter, phase II trial. J Clin Endocrinol Metab. 2010 Jun;95(6):2781-9. doi: 10.1210/jc.2009-2272. Epub 2010 Apr 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pasireotide (SOM230), Octreotide (Sandostatin) in people with Acromegaly, run by Novartis Pharmaceuticals at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulating GH- and IGF-1 concentrations measured every 2 weeks (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00088582, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2016.