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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00171730
Other study ID # CSOM230B2201E1
Secondary ID 2004-002849-12
Status Completed
Phase Phase 2
First received
Last updated
Start date August 24, 2004
Est. completion date December 6, 2013

Study information

Verified date September 2021
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Acromegaly is a rare, serious condition characterized by chronic hypersecretion of growth hormone (GH), generally caused by a GH-secreting pituitary adenoma. The study assessed the long-term safety and efficacy of pasireotide in participants with acromegaly.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 6, 2013
Est. primary completion date December 6, 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Participants who have completed all four treatment regimens in the core study CSOM230B2201 (NCT00088582) and achieved biochemical control in growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels after at least one month of pasireotide administration at any of the three doses. - Participants who did not experience any unacceptable adverse events or tolerability issues during the core study CSOM230B2201. Exclusion Criteria: - Participants who experienced or developed compression of the optic chiasm causing any visual field defect during the core study CSOM230B2201. - Participants who required a surgical intervention for relief of any sign or symptom associated with tumor compression during the core study CSOM230B2201. - Participants who experienced or developed congestive heart failure, unstable angina, sustained ventricular tachycardia, ventricular fibrillation or acute myocardial infraction during the core study CSOM230B2201. Other protocol-defined inclusion/exclusion criteria may apply.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Pasireotide


Locations

Country Name City State
Australia Novartis Investigative Site Woolloongabba Queensland
Belgium Novartis Investigative Site Edegem
France Novartis Investigative Site Toulouse Cédex 4
Germany Novartis Investigative Site Essen
Germany Novartis Investigative Site Muenchen
Italy Novartis Investigative Site Napoli
Switzerland Novartis Investigative Site Lausanne
United States University of Michigan Health System StudyCoordinatorCSOM230B2201E1 Ann Arbor Michigan
United States Cedars Sinai Medical Center Dept. of Pituitary Ctr. Los Angeles California
United States NYU / VA Medical Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  France,  Germany,  Italy,  Switzerland, 

References & Publications (1)

Petersenn S, Farrall AJ, De Block C, Melmed S, Schopohl J, Caron P, Cuneo R, Kleinberg D, Colao A, Ruffin M, Hermosillo Reséndiz K, Hughes G, Hu K, Barkan A. Long-term efficacy and safety of subcutaneous pasireotide in acromegaly: results from an open-end — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Growth Hormone (GH) and Insulin-like Growth Factor 1 (IGF-1) Observed Response by Dose Class A participant was a responder to a dose level if the mean GH level after dosing (t30, t60, t90, and t120) was below/equal to 2.5 microgram/litre (µg/L), and if the mean of IGF-1 of the two pre-dose values (t-30, t-1) was within normal limits for age-sex matched controls. If three or more of t30, t60, t90, or t120 were missing, mean GH was considered missing. If either t-30 or t-1 was missing, mean IGF-1 was considered missing. Pasireotide incident dose classes were defined by total daily doses ranges (<1200 µg/d, 1200 to <1500 µg/d, = 1500 µg/d). Month 9 (Month 9 visit is at the completion of six months in this extension study)
Secondary Time to Tumor Response Time to tumor response was defined as time from Sandostatin baseline (core study baseline) to at least 20% decrease in tumor volume. Core study baseline to at least a 20% decrease in pituitary tumor volume (up to approximately 114 months)
Secondary Summary Magnetic Resonance Imaging (MRI) Pituitary Tumor Volumes Pituitary Tumor Volumes were assessed by MRI. Core study baseline was defined as the last non-missing observation prior to the start of Sandostatin s.c. treatment. Core study baseline, Months 9, 27, 63, 75 and 99
Secondary Percentage of Participants With Symptoms of Acromegaly Participants scored the following symptoms of acromegaly: Headache, perspiration, paresthesia, fatigue, osteoarthralgia, and carpal tunnel syndrome on a 5-point scale (0 = None/absent, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Very severe). Core study baseline till the last assessment of the extension study (up to approximately 114 months)
Secondary Percentage of Participants With Sleep Apnea Symptoms as Assessed by Epworth Sleepiness Scale by Situation Sleep apnea symptoms were assessed using the Epworth Sleepiness Scale (ESS). The ESS is a self-administered questionnaire with 8 questions. It provides a measure of a person's general level of daytime sleepiness, or average sleep propensity in daily life. Percentage of participants were reported in 8 different situations: sitting and reading; watching TV; sitting, inactive in a public place; passenger in a car, an hour without break; lying down to rest in the afternoon; sitting and talking to someone; sitting quietly after a lunch without alcohol; and in a car, stopped a few minutes in the traffic. The participants were rated: 0 = would never doze, 1 = slight chance of dozing, 2 = moderate chance of dozing, 3 = high chance of dozing. Higher scores indicate more severe daytime sleepiness. Core study baseline till the last assessment of the extension study (up to approximately 114 months)
Secondary Percentage of Participants With One or More Adverse Events (AEs) An AE was any undesirable sign, symptom or medical condition that occurred after starting study drug even if the event was not considered to be related to study drug. Percentage of participants with any AE were categorized by pasireotide incident dose classes, which were defined by total daily doses ranges (<1200 µg/d, 1200 to <1500 µg/d, = 1500 µg/d). From start of study drug treatment up to end of study (approximately 111 months)
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