AcromegalyPhase 4NCT00376064
Efficacy of Octreotide Acetate and Cabergoline in Patients With Acromegaly
A Phase 4 study testing Octreotide acetate and cabergoline/Octrotide and Somavert in people with Acromegaly, run by Novartis Pharmaceuticals at 16 sites in Germany.
Trial summary
This study will investigate the efficacy of a combination treatment with octreotide acetate and cabergoline in acromegalic patients that are only partially responsive to a somatostatin analog monotherapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly
- What is being tested?
- Octreotide acetate and cabergoline/Octrotide and Somavert
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 16 sitesGermany
- Study dates
- Mar 2006to Jan 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients (> 18 years) with prior surgery of micro- or macroadenoma of the pituitary.
- At least 6 months chronic treatment with 30mg octreotide (long acting release).
- Partial responsiveness, which is defined as follows: at any one point within the 6 months monotherapy with 30mg/month octreotide (long acting release) the patient must have experienced a decrease in GH and IGF-1 of at least 25% as compared to pre-monotherapy values (= baseline). Note: For efficacy analysis GH- and IGF-1-values measured in the central laboratory at visit 1 (=study baseline) will be used.
- Lack of suppression of GH nadir to < 1.0 µg/L, after oral administration of 75 g of glucose (OGTT) and IGF-I levels at least 10% above the normal value ± 2 SD (adjusted for age and gender; Brabant 2003) must be proven within 4 weeks prior to visit 1. However, if acromegaly symptoms are inadequately controlled as defined in the acromegaly comorbidities and symptom evaluation (as judged by the investigator), an abnormal GH or IGF-1-value as defined above is sufficient.
- Patient's written informed consent.
Who cannot join
- Requires surgery for recent significant deterioration in visual fields or other neurological signs, which are related to the pituitary tumor mass.
- Radiotherapy planned or radiotherapy for acromegaly within the last 2 years.
- Symptomatic cholelithiasis that is clinically relevant.
- Receiving treatment with dopamine agonists within the last 6 months or prior treatment with GH-receptor-antagonists.
- Patients with renal insufficiency, Raynaud-Syndrome or gastrointestinal ulcer/ bleeding cannot be included in the study or psychose in anamnesis.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Germany16 sites
Novartis Investigative Site
Aachen
Novartis Investigative Site
Berlin
Novartis Investigative Site
Bochum
Novartis Investigative Site
Cologne
Novartis Investigative Site
Erlangen
Novartis Investigative Site
Essen
Novartis Investigative Site
Greifswald
Novartis Investigative Site
Heidelberg
Novartis Investigative Site
Leipzig
Novartis Investigative Site
Marburg
Novartis Investigative Site
München
Novartis Investigative Site
Oldenburg
Novartis Investigative Site
Regensburg
Novartis Investigative Site
Tübingen
Novartis Investigative Site
Ulm
Novartis Investigative Site
Würzburg
About this study
Official title: A Multicenter, Single Arm, Proof of Concept Study to Investigate the Efficacy of an 8 Month Combination Therapy of Octreotide and Cabergoline in Acromegalic Patients Only Partially Responsive to Somatostatin Analog Monotherapy
This study will investigate the efficacy of a combination treatment with octreotide acetate and cabergoline in acromegalic patients that are only partially responsive to a somatostatin analog monotherapy
- Conditions
- Acromegaly
- Being tested
- Octreotide acetate and cabergoline/Octrotide and Somavert
- Keywords
- Growth hormone (GH), IGF-1, Acromegaly, Pituitary adenoma, Brain tumor, Brain cancer, Octreotide acetate
- Medical subject headings
- Acromegaly, Pituitary Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Octreotide acetate and cabergoline/Octrotide and SomavertDrug
| Study group | Role | What they receive |
|---|---|---|
| SMS995 + Carbegolin, Somavert + SMS995 | Experimental | Not described Receives: Drug: Octreotide acetate and cabergoline/Octrotide and Somavert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical control (% of patients) as measured by GH- and IGF-1-values (baseline, EOS)
Measured: 8 months
Secondary outcomes (5)
Effect of tumor size
Measured: 8 months
Biochemical control (mean, normalization) as measured by GH- and/or IGF-1-values
Measured: 8 months
Control clinical of symptoms of acromegaly
Measured: 8 months
Quality of Life assessment
Measured: 8 months
Safety and tolerability as assessed by frequency of AEs
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2006 (estimated)
- Study startMar 2006
- Primary completionJan 2010
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
- Not applicable
- 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)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmeceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00376064
- Sponsor's protocol ID
- CSMS995BDE16
- Status last verified
- Sep 2011
- First submitted
- 13 Sep 2006
- Last updated
- 6 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single Arm, Proof of Concept Study to Investigate the Efficacy of an 8 Month Combination Therapy of Octreotide and Cabergoline in Acromegalic Patients Only Partially Responsive to Somatostatin Analog Monotherapy
- ClinicalTrials.gov ID
- NCT00376064
- Acronym / sponsor ID
- CSMS995BDE16
- Conditions
- Acromegaly
- Keywords
- Growth hormone (GH), IGF-1, Acromegaly, Pituitary adenoma, Brain tumor, Brain cancer, Octreotide acetate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Jan 2010 (actual)
- First posted
- 14 Sep 2006 (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.
This study will investigate the efficacy of a combination treatment with octreotide acetate and cabergoline in acromegalic patients that are only partially responsive to a somatostatin analog monotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SMS995 + Carbegolin, Somavert + SMS995 | Experimental | Drug: Octreotide acetate and cabergoline/Octrotide and Somavert |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female patients (> 18 years) with prior surgery of micro- or macroadenoma of the pituitary.
- At least 6 months chronic treatment with 30mg octreotide (long acting release).
- Partial responsiveness, which is defined as follows: at any one point within the 6 months monotherapy with 30mg/month octreotide (long acting release) the patient must have experienced a decrease in GH and IGF-1 of at least 25% as compared to pre-monotherapy values (= baseline). Note: For efficacy analysis GH- and IGF-1-values measured in the central laboratory at visit 1 (=study baseline) will be used.
- Lack of suppression of GH nadir to < 1.0 µg/L, after oral administration of 75 g of glucose (OGTT) and IGF-I levels at least 10% above the normal value ± 2 SD (adjusted for age and gender; Brabant 2003) must be proven within 4 weeks prior to visit 1. However, if acromegaly symptoms are inadequately controlled as defined in the acromegaly comorbidities and symptom evaluation (as judged by the investigator), an abnormal GH or IGF-1-value as defined above is sufficient.
- Patient's written informed consent.
Key exclusion criteria (6 listed)
- Requires surgery for recent significant deterioration in visual fields or other neurological signs, which are related to the pituitary tumor mass.
- Radiotherapy planned or radiotherapy for acromegaly within the last 2 years.
- Symptomatic cholelithiasis that is clinically relevant.
- Receiving treatment with dopamine agonists within the last 6 months or prior treatment with GH-receptor-antagonists.
- Patients with renal insufficiency, Raynaud-Syndrome or gastrointestinal ulcer/ bleeding cannot be included in the study or psychose in anamnesis.
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 acetate and cabergoline/Octrotide and Somavert | Drug | SMS995 + Carbegolin, Somavert + SMS995 |
Primary outcome
Biochemical control (% of patients) as measured by GH- and IGF-1-values (baseline, EOS)
Time frame: 8 months
5 secondary outcomes
Effect of tumor size
Time frame: 8 months
Biochemical control (mean, normalization) as measured by GH- and/or IGF-1-values
Time frame: 8 months
Control clinical of symptoms of acromegaly
Time frame: 8 months
Quality of Life assessment
Time frame: 8 months
Safety and tolerability as assessed by frequency of AEs
Time frame: 8 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 6 Mar 2017.
Related trials for Acromegaly
RecruitingPhase 1
A Phase 1 Clinical Trial of NTQ6179 Tablets in Healthy Volunteers
Acromegaly
RecruitingObservational study
An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly
Acromegaly
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
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RecruitingObservational study
An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
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Recruiting
Managing Pasireotide-associated Hyperglycaemia in Acromegaly With Ketogenic Diet
Acromegaly Due to Pituitary Adenoma, Hyperglycemia
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 Pharmeceuticals
16 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 acetate and cabergoline/Octrotide and Somavert in people with Acromegaly, run by Novartis Pharmaceuticals at 16 sites in Germany.
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 5 inclusion and 6 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 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Germany. 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?
Biochemical control (% of patients) as measured by GH- and IGF-1-values (baseline, EOS) (time frame: 8 months). 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 6 Mar 2017.