Status:
COMPLETED
Effects of Sandostatin LAR® in Acromegaly
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Novartis
Conditions:
Acromegaly
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study aims primarily to determine the effect Insulin-like Growth Factor 1 (IGF-1) normalization into current IGF-I normal ranges with Sandostatin LAR® therapy on biochemical metabolic, cardiovasc...
Detailed Description
A major goal of treatment of acromegaly is to normalize serum IGF-1 levels. Recently developed new normative data for serum IGF-1 levels has lowered the upper limit of normal for this hormone level. O...
Eligibility Criteria
Inclusion
- Adults (age \> 18 years) with diagnosis of Acromegaly ( previously confirmed by an elevated IGF-1 level)
- IGF-1 concentrations\> 10% above the upper limit of normal at screening
- If the patient have undergone surgical resection of a pituitary adenoma, A minimum of two months must have elapsed post surgery prior to enrollment
- May have a history of radiotherapy
- Stable pituitary hormone supplements(x months) prior to baseline visit
- if female ,
- not pregnant (as evidence by negative serum pregnancy test) or lactating; and
- If childbearing potential, agree to use a medically acceptable form of contraception (such as oral, implantable, or barrier contraception) from the screening, for the duration of the study, and for at least on month after study discontinuation or completion. Childbearing potential is defined as women who are not surgically sterile or not at least one year postmenopausal.
- Sign and date an consent form document indicating that the subject (or legally acceptable representative) has been informed of and agrees to all pertinent aspects of trial
Exclusion
- Have other conditions that may result in abnormal growth hormone (GH) and/or IGF-1 concentrations (e.g., severe hepatic disease, severe renal disease Malnutrition, treatment with levodopa)
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 x Upper limit of normal or clinically significant hepatic disease
- Prior somatostatin analog therapy within 6 months of the screening visit
- Other medical therapy for acromegaly for 6 weeks to screening visit
- Visual field defects or other neurological symptoms due to tumor mass
- Have known or suspected drug or alcohol abuse
- Have received an investigational medication within four week prior to screening or is scheduled to received any investigational medication during the study
- Do not have ability to fully comprehend the nature of the study, to follow instructions, cooperate with study procedures, and/or are unable to adhere to the visit scheduled outlined in the protocol
- Have other severe acute or chronic medical or psychiatry condition or Laboratory abnormality that may increase the risk associated with study Participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
- Patient who have known hypersensitivity to Sandostatin acetate or other related drug or compound
- Patient with current gallstones
- Patient who have received supraphysiologic doses of glucocorticoid within the past 6 months (except for peri-operative (\<3 days duration) of dexamethasone) or who currently received chemotherapeutics agents, or exogenous growth hormone
- Patients who have received other investigational drugs administered or Received within 30 days of study entry
- Patients who exhibit symptoms indicative of intolerance during the 2 weeks Course of Sandostatin injection.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01424241
Start Date
October 1 2006
End Date
January 1 2014
Last Update
July 24 2024
Active Locations (1)
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1
Columbia University Medical Center
New York, New York, United States, 10032