AcromegalyPhase 4NCT00171886
Octreotide Efficacy and Safety in First-line Acromegalic Patients
A Phase 4 study testing Octreotide in people with Acromegaly, run by Novartis Pharmaceuticals at 8 sites in Spain.
Trial summary
Primary Acromegaly is a clinical and metabolic disease caused by growth hormone (GH) hypersecretion from a pituitary adenoma and is an insidious, chronic disease that is associated with bony and soft tissue overgrowth. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acromegaly
- What is being tested?
- Octreotide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 8 sitesSpain
- Study dates
- Jul 2002to May 2006
- Phase
- Phase 4
- 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
- Males and females 18 and < 80 years old.
- Recently diagnosed not previously treated patients with acromegaly.
- Presence of a pituitary tumor (microadenoma or macroadenoma), documented by a MNR performed in the 12 weeks before enrolment.
- Absence of nadir suppression of the nadir of GH to < 1.0 ng/mL, after oral administration of 75 g of glucose (OTTG).
- IGF-I levels over normal upper limits, e.g. 97 percentile (age- and sex-matched).
- Tolerance shown with a test of a subcutaneous injection of octreotide
- Written Informed Consent before any procedure specific to the study. Inclus
Who cannot join
- Previously treated patients with any therapy for acromegaly, including surgery, radiotherapy, bromocriptin, and somatostatin analogues.
- Compression of optic chiasm that produces any impairment of field of vision.
- Need of surgery to improve any neurological sign or symptom associated with a direct incidence on the tumour.
- Intolerance to octreotide or to any component of Sandostatin® LAR® preparation.
- Patients with an hepatic condition such as cirrhosis, active or persisting chronic hepatitis, or other hepatopathy of fast evolution.
- Pregnant women
Show all 10Show fewer
- History of alcohol or drug abuse in the six months prior to the inclusion visit.
- Patients suffering from any condition that may jeopardize the interpretation of study results or may impede to obtain informed consent
- Intake of an investigational drug during the study and 30 days before patient inclusion in this study
- Other protocol-defined inclusion / exclusion criteria may apply.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Spain8 sites
Novartis Investigative site
A Coruña
Novartis Investigative site
Alicante
Novartis Investigative site
Barcelona
Novartis Investigative site
Burgos
Novartis Investigative site
Córdoba
Novartis Investigative site
Madrid
Novartis Investigative site
Málaga
Novartis Investigative site
Tarragona
About this study
Primary Acromegaly is a clinical and metabolic disease caused by growth hormone (GH) hypersecretion from a pituitary adenoma and is an insidious, chronic disease that is associated with bony and soft tissue overgrowth. Goals of therapy are to eradicate the tumor, suppress GH secretion, normalize IGF-I levels, and preserve normal pituitary function.
This study will evaluate the safety and efficacy of octreotide as primary therapy for the treatment of acromegaly and as therapy for patients with acromegaly and a pituitary macroadenoma or microadenoma.
- Conditions
- Acromegaly
- Being tested
- Octreotide
- Keywords
- Acromegaly, Otreotide, Tumor reduction
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OctreotideDrug
Also called SMS995
| Study group | Role | What they receive |
|---|---|---|
| octrotide | Experimental | Not described Receives: Drug: Octreotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the ability of Sandostatin® LAR® to decrease GH and IGF-I levels in acromegaly patients with micro- or macroadenomas not previously treated
Measured: at baseline, weeks 12, 24, 48
To evaluate efficacy of Sandostatin® LAR® to reduce the size of micro- or macroadenomas in acromegaly patients with micro- or macroadenomas not previous treated
Measured: at baseline, weeks 12, 24, 48
Secondary outcomes (2)
To evaluate the effect of Sandostatin® LAR® on Health Related Quality of Life.
Measured: at baseline, weeks 12, 24, 48
To evaluate the ability of Sandostatin® LAR® to relieve acromegaly signs and symptoms
Measured: at baseline, weeks 12, 24, 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJul 2002
- Primary completionMay 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00171886
- Sponsor's protocol ID
- CSMS995BES02
- Status last verified
- Mar 2011
- First submitted
- 13 Sep 2005
- Last updated
- 24 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Octreotide Efficacy and Safety in First-line Acromegalic Patients
- ClinicalTrials.gov ID
- NCT00171886
- Acronym / sponsor ID
- CSMS995BES02
- Conditions
- Acromegaly
- Keywords
- Acromegaly, Otreotide, Tumor reduction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2002
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 15 Sep 2005 (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.
Primary Acromegaly is a clinical and metabolic disease caused by growth hormone (GH) hypersecretion from a pituitary adenoma and is an insidious, chronic disease that is associated with bony and soft tissue overgrowth. Goals of therapy are to eradicate the tumor, suppress GH secretion, normalize IGF-I levels, and preserve normal pituitary function.
This study will evaluate the safety and efficacy of octreotide as primary therapy for the treatment of acromegaly and as therapy for patients with acromegaly and a pituitary macroadenoma or microadenoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| octrotide | Experimental | Drug: Octreotide |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females 18 and < 80 years old.
- Recently diagnosed not previously treated patients with acromegaly.
- Presence of a pituitary tumor (microadenoma or macroadenoma), documented by a MNR performed in the 12 weeks before enrolment.
- Absence of nadir suppression of the nadir of GH to < 1.0 ng/mL, after oral administration of 75 g of glucose (OTTG).
- IGF-I levels over normal upper limits, e.g. 97 percentile (age- and sex-matched).
Key exclusion criteria (10 listed)
- Previously treated patients with any therapy for acromegaly, including surgery, radiotherapy, bromocriptin, and somatostatin analogues.
- Compression of optic chiasm that produces any impairment of field of vision.
- Need of surgery to improve any neurological sign or symptom associated with a direct incidence on the tumour.
- Intolerance to octreotide or to any component of Sandostatin® LAR® preparation.
- Patients with an hepatic condition such as cirrhosis, active or persisting chronic hepatitis, or other hepatopathy of fast evolution.
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 |
|---|---|---|
| OctreotideAlso: SMS995 | Drug | octrotide |
Primary outcome
To evaluate the ability of Sandostatin® LAR® to decrease GH and IGF-I levels in acromegaly patients with micro- or macroadenomas not previously treated
Time frame: at baseline, weeks 12, 24, 48
To evaluate efficacy of Sandostatin® LAR® to reduce the size of micro- or macroadenomas in acromegaly patients with micro- or macroadenomas not previous treated
Time frame: at baseline, weeks 12, 24, 48
2 secondary outcomes
To evaluate the effect of Sandostatin® LAR® on Health Related Quality of Life.
Time frame: at baseline, weeks 12, 24, 48
To evaluate the ability of Sandostatin® LAR® to relieve acromegaly signs and symptoms
Time frame: at baseline, weeks 12, 24, 48
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 24 Feb 2017.
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A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
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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
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Octreotide in people with Acromegaly, run by Novartis Pharmaceuticals at 8 sites in Spain.
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 7 inclusion and 10 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 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
To evaluate the ability of Sandostatin® LAR® to decrease GH and IGF-I levels in acromegaly patients with micro- or macroadenomas not previously treated (time frame: at baseline, weeks 12, 24, 48). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2017.