AcromegalyPhase 2NCT00001860
Sandostatin LAR Depot vs. Surgery for Treating Acromegaly
A Phase 2 study testing Sandostatin LAR Depot versus transsphenoidal surgery in people with Acromegaly and Pituitary Neoplasm, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
The purpose of this study is to compare the efficacy of Sandostatin LAR® (Registered Trademark) Depot to transsphenoidal surgery in previously untreated acromegalic patients with macroadenomas. The primary goal is to normalize insulin-like growth factor-1 (IGF-1) levels. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acromegaly, Pituitary Neoplasm
- What is being tested?
- Sandostatin LAR Depot versus transsphenoidal surgery
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1999to Jul 2002
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female patients, 18 years of age or older.
- Newly diagnosed patients with acromegaly, or previously untreated.
- Presence of a pituitary tumor greater than 10 mm at greatest diameter (macroadenoma).
- Lack of suppression of GH to less than 2.0 ng/mL using a regular GH RIA, or less than one ng/mL using a two-site immunoradiometric or chemiluminescent GH assay, after oral administration of 100 g of glucose.
- IGF-1 levels above the upper limits of normal (adjusted for age and gender).
- Demonstrated tolerance to a test dose of s.c. Sandostatin Injection.
- Demonstrated responsiveness to a 100 ug s.c. Sandostatin Injection test dose, as evidenced by suppression of mean 4HR GH to less than 5 ng/mL, or to greater than 50 % of the baseline value.
- Patients who are able to provide written informed consent.
Who cannot join
- Patients demonstrating intolerance to a s.c. Sandostatin (octreotide acetate) test dose.
- Patients who have received any prior treatment for their acromegaly, including radiotherapy, octreotide, bromocriptine, lanreotide, or prior surgery.
- Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control.
- Patients with compression of the optic chiasm significant enough to cause visual field defects on automated testing.
- Patients who require surgery for relief of any neurologic signs or symptoms associated with their tumor.
- Patients with symptomatic cholelithiasis.
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- Patients who have congestive heart failure (NYHA Class III and IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation, or a history of acute myocardial infarction within the three months preceding study entry.
- Patients with liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis, or persistent ALT, AST, or alkaline phosphatase 2X greater than upper limit of normal; or direct bilirubin more than 10% greater than upper limit of normal.
- Patients with abnormal clinical laboratory values considered by the Investigator or the Sponsor's Medical Monitor to be clinically significant and which could affect the interpretation of the study results.
- Patients who have any current or prior medical condition that may interfere with the conduct of the study or of the evaluation of its result in the opinion of the Investigator or Sponsor's Medical Monitor.
- Patients who have a history of alcohol or drug abuse in the six month period prior to Visit 1.
- Patients who have received any investigational drug within one month prior to Visit 1, or who plan to take an investigational drug during the study.
- Patients with any mental impairment limiting their ability to comply with all study requirements.
- Patients who, for any reason, will be unable to complete the entire study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Bethesda, Maryland, 20892
About this study
Official title: Sandostatin LAR vs. Surgery in Acromegalics With Macroadenoma
The purpose of this study is to compare the efficacy of Sandostatin LAR® (Registered Trademark) Depot to transsphenoidal surgery in previously untreated acromegalic patients with macroadenomas. The primary goal is to normalize insulin-like growth factor-1 (IGF-1) levels. Secondary goals are to compare Sandostatin LAR® (Registered Trademark) Depot treatment and transsphenoidal surgery to achieve the following goals: suppress growth hormone levels to less than or equal to 2.5 ng/mL, relieve the clinical signs and symptoms of acromegaly, reduce the size of the macroadenomas, produce few side effects, assess the prognostic value of baseline pituitary adenoma size, extension and baseline growth hormone level on post-treatment growth hormone and IGF-1 levels, and assess the resource utilization of each treatment type.
Read the detailed description
The purpose of this study is to compare the efficacy of Sandostatin LAR® (Registered Trademark) Depot to transsphenoidal surgery in previously untreated acromegalic patients with macroadenomas. The primary goal is to normalize insulin-like growth factor-1 (IGF-1) levels. Secondary goals are to compare Sandostatin LAR® (Registered Trademark) Depot treatment and transsphenoidal surgery to achieve the following goals: suppress growth hormone levels to less than or equal to 2.5 ng/mL, relieve the clinical signs and symptoms of acromegaly, reduce the size of the macroadenomas, produce few side effects, assess the prognostic value of baseline pituitary adenoma size, extension and baseline growth hormone level on post-treatment growth hormone and IGF-1 levels, and assess the resource utilization of each treatment type.
- Conditions
- Acromegaly, Pituitary Neoplasm
- Being tested
- Sandostatin LAR Depot versus transsphenoidal surgery
- Keywords
- Growth Hormone, Somatostatin, Insulin-like Growth Factor-One, Acromegaly, Macroadenoma
- Medical subject headings
- Acromegaly, Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sandostatin LAR Depot versus transsphenoidal surgeryDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startAug 1999
- Study completionJul 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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
- Enrolment
- 5 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001860
- Sponsor's protocol ID
- 990162
- Other IDs
- 99-DK-0162
- Status last verified
- Jul 2002
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Barkan AL. Acromegaly. Diagnosis and therapy. Endocrinol Metab Clin North Am. 1989 Jun;18(2):277-310.
PubMed 2663476Bates AS, Van't Hoff W, Jones JM, Clayton RN. An audit of outcome of treatment in acromegaly. Q J Med. 1993 May;86(5):293-9.
PubMed 8327647Melmed S, Jackson I, Kleinberg D, Klibanski A. Current treatment guidelines for acromegaly. J Clin Endocrinol Metab. 1998 Aug;83(8):2646-52. doi: 10.1210/jcem.83.8.4995.
PubMed 9709926
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sandostatin LAR vs. Surgery in Acromegalics With Macroadenoma
- ClinicalTrials.gov ID
- NCT00001860
- Acronym / sponsor ID
- 990162
- Conditions
- Acromegaly, Pituitary Neoplasm
- Keywords
- Growth Hormone, Somatostatin, Insulin-like Growth Factor-One, Acromegaly, Macroadenoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Aug 1999
- Study completion
- Jul 2002
- First posted
- 4 Nov 1999 (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.
The purpose of this study is to compare the efficacy of Sandostatin LAR® (Registered Trademark) Depot to transsphenoidal surgery in previously untreated acromegalic patients with macroadenomas. The primary goal is to normalize insulin-like growth factor-1 (IGF-1) levels. Secondary goals are to compare Sandostatin LAR® (Registered Trademark) Depot treatment and transsphenoidal surgery to achieve the following goals: suppress growth hormone levels to less than or equal to 2.5 ng/mL, relieve the clinical signs and symptoms of acromegaly, reduce the size of the macroadenomas, produce few side effects, assess the prognostic value of baseline pituitary adenoma size, extension and baseline growth hormone level on post-treatment growth hormone and IGF-1 levels, and assess the resource utilization of each treatment type.
Detailed description
The purpose of this study is to compare the efficacy of Sandostatin LAR® (Registered Trademark) Depot to transsphenoidal surgery in previously untreated acromegalic patients with macroadenomas. The primary goal is to normalize insulin-like growth factor-1 (IGF-1) levels. Secondary goals are to compare Sandostatin LAR® (Registered Trademark) Depot treatment and transsphenoidal surgery to achieve the following goals: suppress growth hormone levels to less than or equal to 2.5 ng/mL, relieve the clinical signs and symptoms of acromegaly, reduce the size of the macroadenomas, produce few side effects, assess the prognostic value of baseline pituitary adenoma size, extension and baseline growth hormone level on post-treatment growth hormone and IGF-1 levels, and assess the resource utilization of each treatment type.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female patients, 18 years of age or older.
- Newly diagnosed patients with acromegaly, or previously untreated.
- Presence of a pituitary tumor greater than 10 mm at greatest diameter (macroadenoma).
- Lack of suppression of GH to less than 2.0 ng/mL using a regular GH RIA, or less than one ng/mL using a two-site immunoradiometric or chemiluminescent GH assay, after oral administration of 100 g of glucose.
- IGF-1 levels above the upper limits of normal (adjusted for age and gender).
Key exclusion criteria (14 listed)
- Patients demonstrating intolerance to a s.c. Sandostatin (octreotide acetate) test dose.
- Patients who have received any prior treatment for their acromegaly, including radiotherapy, octreotide, bromocriptine, lanreotide, or prior surgery.
- Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control.
- Patients with compression of the optic chiasm significant enough to cause visual field defects on automated testing.
- Patients who require surgery for relief of any neurologic signs or symptoms associated with their tumor.
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 |
|---|---|---|
| Sandostatin LAR Depot versus transsphenoidal surgery | Drug | – |
Primary outcome
Not reported in the source record.
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 4 Mar 2008.
- Background: PubMed 2663476Barkan AL. Acromegaly. Diagnosis and therapy. Endocrinol Metab Clin North Am. 1989 Jun;18(2):277-310.
- Background: PubMed 8327647Bates AS, Van't Hoff W, Jones JM, Clayton RN. An audit of outcome of treatment in acromegaly. Q J Med. 1993 May;86(5):293-9.
- Background: PubMed 9709926Melmed S, Jackson I, Kleinberg D, Klibanski A. Current treatment guidelines for acromegaly. J Clin Endocrinol Metab. 1998 Aug;83(8):2646-52. doi: 10.1210/jcem.83.8.4995.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sandostatin LAR Depot versus transsphenoidal surgery in people with Acromegaly and Pituitary Neoplasm, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site 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 8 inclusion and 14 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 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001860, which also lists 3 linked publications.
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 4 Mar 2008.