AcromegalyPhase 3NCT00765323
Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly
A Phase 3 study testing Octreotide Implant and Sandostatin LAR Depot in people with Acromegaly, run by Endo USA Inc., a Keenova Therapeutics Company at 47 sites in 9 countries.
Trial summary
Evaluate the efficacy, safety and tolerability of the octreotide implant in patients with acromegaly that were previously treated with octreotide depot. 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 Implant and Sandostatin LAR Depot
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 47 sitesin 9 countries
- Study dates
- Sep 2008to Jun 2011
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients with acromegaly
- Confirmed diagnosis of a growth hormone-secreting tumor
- Received a stable dose of monthly octreotide depot injections for a minimum of 3 consecutive months immediately prior to screening
- Must show a response to octreotide treatment with documented laboratory results at the screening visits defined as follows: IGF-1 < 20% above the upper limit of normal age and sex-adjusted levels and GH ≤ 2.5 ng/mL
Who cannot join
- Patients with pituitary surgery less than 3 months prior to screening
- Uncontrolled diabetes defined as having a fasting glucose > 150 mg/dl and HbA1c >= 9%
- Symptomatic cholelithiasis
- Received pegvisomant, Lanreotide, or a dopamine agonist within 3 months of screening, or at any time during the trial
- Received radiotherapy for pituitary tumor or any radiotherapy above the neck at any time before Screening
Trial locations and contacts
47 sites in 9 countries.
47 sites in 9 countries
Russia15 sites
State Institution of Healthcare "Regional Clinical Hospital"
Barnaul
State Intitution of Healthcare "Mark of Honour "Irkutsk Regional Clinical Hospital"
Irkutsk
State Institution of Healthcare "Kemerovo State Clinical Hospital"
Kemerovo
Regional State Institution of Healthcare "Regional State Hospital"
Krasnoyarsk
Federal State Institution "Endocrinology Research Center of Rosmedtechnology"
Moscow
State Educational Institution of High Professional Education "Moscow Medical Academy named after I.M. Sechenov of Federal Agency of Healthcare and Social Development"
Moscow
State Institution Moscow Regional Scientific-Research Clinical Institute named after M.F. Vladimirsky
Moscow
State Institution of Healthcare "N. Novgorod Regional Clinical Hospital named after N.A. Semashko"
Nizhny Novgorod
State Educational Institution of High Professional Education "Novosibirsk State medical Univeristy of Federal Agency of Healthcare and Social Development
Novosibirsk
State Educational Institution of High Professional Education "Perm State Medical Academy named after academician E.A.Vagner of Roszdrav"
Perm
National Educational Institution of Additional Professional Education "St. Petersburg Medical Academy of Postgraduate Studies of Roszdrav"
Saint Petersburg, Russian Federation
Federal State Institution "federal Center of Heart, Blood and Endocrinology named after V.A. Almazov of Rosmedtechnology"
Saint Petersburg
Center "Diabetes", LLC
Samara
State Educational Institution of High Professional Education "Siberian State Medical University of Federal Agency of Healthcare and Social Development"
Tomsk
Municipal Health Care Institution Clinical Hospital for Emergency Medical Care named after N.V. Solovyov
Yaroslavl
United States8 sites
Sinai Hospital of Baltimore, Medicine - Div. of Endocrinology and Metabolism
Baltimore, Maryland, 21215
The University of Illinois at Chicago
Chicago, Illinois, 60608
The Cleveland Clinic
Cleveland, Ohio, 44195
University of Colorado - Veterans Administration Medical Center - Endocrinology
Denver, Colorado, 80220
Galiz Research
Miami, Florida, 33145
Stanford University Medical Center - Stanford Hospitals and Clinics
Palo Alto, California, 94304
Oregon Health and Science University, Endocrinology
Portland, Oregon, 97239
Seattle Neuroscience Institute - Swedish Medical Center
Seattle, Washington, 98122
Germany8 sites
Charité Berlin, Campus Benjamin Franklin, Abteilung fϋr Endokrinologie, Diabetes und Ernährungsmedizin
Berlin
Universitätsklinikum zu Köln, Klinik und Poliklinik II Innnere
Cologne
Universitätsklinikum Erlangen, Medizinische Klinik 1, Gastroenterologie, Pneumologie und Endokrinologie
Erlangen
Klinikum der Johann Wolfgang Goethe-Universität, Medizinische Klinik 1, Endokrinologie
Frankfurt
Universitätsklinikum Hamburg-Eppendorf - Bereich Endokrinologie, Diabetologie und Adipositas
Hamburg
Universitätsklinikum Schleswig-Holstein, Medizinische Klinik 1
Lübeck
Klinik für Endokrinologie und Stoffwechselkrankheiten Otto-von-Guericke-Universität Magdeburg
Magdeburg
Klinikum der Philipps Universitaet Marburg Bereich Endokrinologie & Diabetologie
Marburg
Poland5 sites
Akademickie Centrum Kliniczne - Szpital Akademii Medycznej w Gdańsku
Gdansk
Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Poznan
Indywidualna Specjalistyczna Praktyka Lekarska Dr n. med. Grzegorz Kulig
Szczecin
Szpital Bielański im. Ks. Jerzego Popiełuszki SPZOZ
Warsaw
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu, Klinika Endokrynologii, Diabetologii i Leczenia Izotopami
Wroclaw
Hungary3 sites
Semmelweis University, Faculty of Medicine, 2nd Department of Medicine
Budapest
University of Debrecen Medical and Health Science Center, Division of Endocrinology
Debrecen
University of Pécs, School of Medicine, 1st Department of Medicine
Pécs
Spain3 sites
Hospital General Universitario de Alicante Endocrinología y Nutrición
Alicante
Hospital Universitario Gregorio Marañón Endocrinología y Nutrición
Madrid
Hospital Universitario la Fé Endocrinología y Nutrición
Valencia
Czechia2 sites
2. interni klinika fakultní nemocnice Hradec Králové
Hradec Králové
3. interni klinika Vseobecne fakultni nemocnice
Prague
Slovakia2 sites
Endotopmed s.r.o., Tehelná
Bratislava
Národný endokrinologický a diabetologický ústav
Lubocna
About this study
Official title: Phase III, Open-Label, Multicenter International Study to Evaluate the Efficacy and Safety of an Octreotide Implant vs. Sandostatin LAR Depot in Patients With Acromegaly
Evaluate the efficacy, safety and tolerability of the octreotide implant in patients with acromegaly that were previously treated with octreotide depot.
Read the detailed description
This study will be conducted in 3 phases: Screening, the Primary Treatment Phase (ie, Day 1 to Week 24), and the Extension Phase (Post Week 24 to Week 48). Primary efficacy and safety will be determined from the Primary Treatment Phase. Eligible patients will be randomized during the Primary Treatment Phase; in a 3 to 1 ratio to receive 6 months of open-label treatment with either the 84 mg octreotide implant or monthy Injections of S-LAR. Each patient in this study will return to the investigational center every 4 weeks; safety and efficacy assessments will be performed during these visits. All patients who complete the Primary Treatment Phase and who continue to meet eligibility criteria will be offered the opportunity to enter the Extension Phase; patients entering the Extension Phase will be treated with an octreotide implant for 6 months.During the Extension Phase, patients will return to the investigational center every 4 weeks; safety and efficacy assessments will be performed during these visits.
- Conditions
- Acromegaly
- Being tested
- Octreotide Implant, Sandostatin LAR Depot
- Keywords
- Octreotide, Sandostatin LAR, Growth hormone, IGF-1
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Octreotide ImplantDrug
Also called somatostatin analogue
84 mg octreotide subcutaneous implant for 6 months
Sandostatin LAR DepotDrug
Also called somatostatin analogue
Injections of Sandostatin LAR (dose range ~10-40 mg every 28 days)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 84 mg octreotide implant for 6 months Receives: Drug: Octreotide Implant |
| 2 | Active comparator | Injections of Sandostatin LAR Depot(20, 30, 40 mg) every 4 weeks Receives: Drug: Sandostatin LAR Depot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy based on IGF-1, GH, signs and symptoms scores, tumor size, QoL and Patient Treatment Assessments
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionFeb 2011
- Study completionJun 2011
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00765323
- Sponsor's protocol ID
- IP107-001
- Status last verified
- Sep 2013
- First submitted
- 30 Sep 2008
- Last updated
- 27 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Chieffo C, Cook D, Xiang Q, Frohman LA. Efficacy and safety of an octreotide implant in the treatment of patients with acromegaly. J Clin Endocrinol Metab. 2013 Oct;98(10):4047-54. doi: 10.1210/jc.2013-2262. Epub 2013 Aug 22.
PubMed 23969184
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III, Open-Label, Multicenter International Study to Evaluate the Efficacy and Safety of an Octreotide Implant vs. Sandostatin LAR Depot in Patients With Acromegaly
- ClinicalTrials.gov ID
- NCT00765323
- Acronym / sponsor ID
- IP107-001
- Conditions
- Acromegaly
- Keywords
- Octreotide, Sandostatin LAR, Growth hormone, IGF-1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 2 Oct 2008 (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.
Evaluate the efficacy, safety and tolerability of the octreotide implant in patients with acromegaly that were previously treated with octreotide depot.
Detailed description
This study will be conducted in 3 phases: Screening, the Primary Treatment Phase (ie, Day 1 to Week 24), and the Extension Phase (Post Week 24 to Week 48). Primary efficacy and safety will be determined from the Primary Treatment Phase. Eligible patients will be randomized during the Primary Treatment Phase; in a 3 to 1 ratio to receive 6 months of open-label treatment with either the 84 mg octreotide implant or monthy Injections of S-LAR. Each patient in this study will return to the investigational center every 4 weeks; safety and efficacy assessments will be performed during these visits. All patients who complete the Primary Treatment Phase and who continue to meet eligibility criteria will be offered the opportunity to enter the Extension Phase; patients entering the Extension Phase will be treated with an octreotide implant for 6 months.During the Extension Phase, patients will return to the investigational center every 4 weeks; safety and efficacy assessments will be performed during these visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Octreotide Implant84 mg octreotide implant for 6 months |
| 2 | Active comparator | Drug: Sandostatin LAR DepotInjections of Sandostatin LAR Depot(20, 30, 40 mg) every 4 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients with acromegaly
- Confirmed diagnosis of a growth hormone-secreting tumor
- Received a stable dose of monthly octreotide depot injections for a minimum of 3 consecutive months immediately prior to screening
- Must show a response to octreotide treatment with documented laboratory results at the screening visits defined as follows: IGF-1 < 20% above the upper limit of normal age and sex-adjusted levels and GH ≤ 2.5 ng/mL
Key exclusion criteria (5 listed)
- Patients with pituitary surgery less than 3 months prior to screening
- Uncontrolled diabetes defined as having a fasting glucose > 150 mg/dl and HbA1c >= 9%
- Symptomatic cholelithiasis
- Received pegvisomant, Lanreotide, or a dopamine agonist within 3 months of screening, or at any time during the trial
- Received radiotherapy for pituitary tumor or any radiotherapy above the neck at any time before Screening
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 ImplantAlso: somatostatin analogue84 mg octreotide subcutaneous implant for 6 months | Drug | 1 |
| Sandostatin LAR DepotAlso: somatostatin analogueInjections of Sandostatin LAR (dose range ~10-40 mg every 28 days) | Drug | 2 |
Primary outcome
Efficacy based on IGF-1, GH, signs and symptoms scores, tumor size, QoL and Patient Treatment Assessments
Time frame: 12 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2013.
- Derived from this study: PubMed 23969184Chieffo C, Cook D, Xiang Q, Frohman LA. Efficacy and safety of an octreotide implant in the treatment of patients with acromegaly. J Clin Endocrinol Metab. 2013 Oct;98(10):4047-54. doi: 10.1210/jc.2013-2262. Epub 2013 Aug 22.
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
Acromegaly
RecruitingObservational study
An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
Panhypopituitarism, Gigantism/Acromegaly
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.
The record lists no contact. Use the official record to reach the sponsor.
47 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Octreotide Implant and Sandostatin LAR Depot in people with Acromegaly, run by Endo USA Inc., a Keenova Therapeutics Company at 47 sites in 9 countries.
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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 27 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in Russia, United States, Germany, Poland, Hungary and 4 more countries. 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 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 was stopped early. Results are not available in the source record.
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?
Efficacy based on IGF-1, GH, signs and symptoms scores, tumor size, QoL and Patient Treatment Assessments (time frame: 12 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 NCT00765323, 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 27 Sep 2013.