AcromegalyPhase 3NCT00128232
Safety and Efficacy of Octreotide Long Acting Release (LAR) in Treatment Naïve Acromegalic Patients
A Phase 3 study testing Octreotide LAR in people with Acromegaly, run by Novartis.
Trial summary
Currently, the first line treatment for acromegaly is surgery, in order to remove the adenoma causing overproduction of growth hormone which leads to acromegaly. Octreotide LAR is approved for treatment of acromegaly after surgery if the disease is not controlled. 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 LAR
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2002to Aug 2004
- Phase
- Phase 3
- 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
- Adult, Older adult
Who may be able to join
- Newly diagnosed or previously untreated acromegalic patients
- Lack of suppression of growth hormone (GH) nadir to <1.0 µg/L, after oral administration of 75g of glucose (oral glucose tolerance test [OGTT])
- Insulin-like growth factor-I (IGF-I) levels above the upper limits of normal, i.e. 97th percentile (adjusted for age and gender)
Who cannot join
- Requires surgery for recent significant deterioration in visual fields or other neurological signs, which are related to the pituitary tumor mass
- No evidence of pituitary adenoma on magnetic resonance imaging (MRI)
- Symptomatic cholelithiasis
About this study
Official title: Safety and Efficacy of Octreotide LAR in Treatment Naïve Acromegalic Patients
Currently, the first line treatment for acromegaly is surgery, in order to remove the adenoma causing overproduction of growth hormone which leads to acromegaly. Octreotide LAR is approved for treatment of acromegaly after surgery if the disease is not controlled. This study was aimed to test the safety and efficacy of octreotide LAR in acromegalic patients who did not have any previous treatment for acromegaly.
- Conditions
- Acromegaly
- Being tested
- Octreotide LAR
- Keywords
- Acromegaly, untreated, newly diagnosed, octreotide LAR
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Octreotide LARDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean GH and IGF-I at baseline, week 12, 24 and 48
Secondary outcomes (3)
Tumor volume at baseline, week 24 and 48
Signs and symptoms of acromegaly at baseline, week 12, 24 and 48
Safety and tolerability at any time on treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2005 (estimated)
- Study startDec 2002
- Primary completionAug 2004
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephan Petersenn, MD, Principal investigator, Universität Duisburg-Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00128232
- Sponsor's protocol ID
- CSMS995B2401
- Status last verified
- Apr 2012
- First submitted
- 8 Aug 2005
- Last updated
- 30 Apr 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Octreotide LAR in Treatment Naïve Acromegalic Patients
- ClinicalTrials.gov ID
- NCT00128232
- Acronym / sponsor ID
- CSMS995B2401
- Conditions
- Acromegaly
- Keywords
- Acromegaly, untreated, newly diagnosed, octreotide LAR
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Aug 2004 (actual)
- First posted
- 9 Aug 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.
Currently, the first line treatment for acromegaly is surgery, in order to remove the adenoma causing overproduction of growth hormone which leads to acromegaly. Octreotide LAR is approved for treatment of acromegaly after surgery if the disease is not controlled. This study was aimed to test the safety and efficacy of octreotide LAR in acromegalic patients who did not have any previous treatment for acromegaly.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Newly diagnosed or previously untreated acromegalic patients
- Lack of suppression of growth hormone (GH) nadir to <1.0 µg/L, after oral administration of 75g of glucose (oral glucose tolerance test [OGTT])
- Insulin-like growth factor-I (IGF-I) levels above the upper limits of normal, i.e. 97th percentile (adjusted for age and gender)
Key exclusion criteria (3 listed)
- Requires surgery for recent significant deterioration in visual fields or other neurological signs, which are related to the pituitary tumor mass
- No evidence of pituitary adenoma on magnetic resonance imaging (MRI)
- Symptomatic cholelithiasis
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 |
|---|---|---|
| Octreotide LAR | Drug | – |
Primary outcome
Mean GH and IGF-I at baseline, week 12, 24 and 48
3 secondary outcomes
Tumor volume at baseline, week 24 and 48
Signs and symptoms of acromegaly at baseline, week 12, 24 and 48
Safety and tolerability at any time on treatment
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 30 Apr 2012.
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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.
Stephan Petersenn, MD principal investigator
Universität Duisburg-Essen
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Octreotide LAR in people with Acromegaly, run by Novartis.
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 3 inclusion and 3 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 30 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Mean GH and IGF-I at baseline, week 12, 24 and 48. 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 30 Apr 2012.