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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00171730
Registration number
NCT00171730
Ethics application status
Date submitted
13/09/2005
Date registered
15/09/2005
Date last updated
5/09/2021
Titles & IDs
Public title
An Extension Study to Assess the Long-Term Safety and Efficacy of Pasireotide in Participants With Acromegaly
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Scientific title
Extension to a Multi-Center, Randomized, Crossover, Open Label, Dose Finding Study to Compare the Safety, Efficacy, and Pharmacokinetics/Pharmacodynamics (PK/PD) Relationship of Multiple Doses of Pasireotide (SOM230) (200, 400, and 600 µg Bid) and Doses of Open Label Sandostatin® (SMS) (100 µg Tid) in Acromegalic Patients
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Secondary ID [1]
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2004-002849-12
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Secondary ID [2]
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CSOM230B2201E1
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acromegaly
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Condition category
Condition code
Metabolic and Endocrine
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Other endocrine disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Pasireotide
Experimental: Pasireotide s.c. Overall - Participants received pasireotide as a daily subcutaneous (s.c) injection, every 12 hours at 9:00 AM and 9:00 PM at the dose at which the biochemical control was achieved (either 200, 400, or 600 microgram (µg)) for as long as the participant benefited from the treatment, and there were no safety or tolerability concerns (median duration of 22.7 months).
Treatment: Drugs: Pasireotide
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Growth Hormone (GH) and Insulin-like Growth Factor 1 (IGF-1) Observed Response by Dose Class
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Assessment method [1]
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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).
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Timepoint [1]
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Month 9 (Month 9 visit is at the completion of six months in this extension study)
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Secondary outcome [1]
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Time to Tumor Response
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Assessment method [1]
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Time to tumor response was defined as time from Sandostatin baseline (core study baseline) to at least 20% decrease in tumor volume.
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Timepoint [1]
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Core study baseline to at least a 20% decrease in pituitary tumor volume (up to approximately 114 months)
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Secondary outcome [2]
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Summary Magnetic Resonance Imaging (MRI) Pituitary Tumor Volumes
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Assessment method [2]
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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.
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Timepoint [2]
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Core study baseline, Months 9, 27, 63, 75 and 99
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Secondary outcome [3]
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Percentage of Participants With Symptoms of Acromegaly
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Assessment method [3]
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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).
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Timepoint [3]
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Core study baseline till the last assessment of the extension study (up to approximately 114 months)
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Secondary outcome [4]
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Percentage of Participants With Sleep Apnea Symptoms as Assessed by Epworth Sleepiness Scale by Situation
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Assessment method [4]
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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.
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Timepoint [4]
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Core study baseline till the last assessment of the extension study (up to approximately 114 months)
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Secondary outcome [5]
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Percentage of Participants With One or More Adverse Events (AEs)
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Assessment method [5]
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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).
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Timepoint [5]
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From start of study drug treatment up to end of study (approximately 111 months)
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
24/08/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
6/12/2013
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Sample size
Target
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Accrual to date
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Final
30
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Novartis Investigative Site - Woolloongabba
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Recruitment postcode(s) [1]
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4102 - Woolloongabba
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Michigan
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Country [3]
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United States of America
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State/province [3]
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New York
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Country [4]
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Belgium
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State/province [4]
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Edegem
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Country [5]
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France
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State/province [5]
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Toulouse Cédex 4
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Country [6]
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Germany
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State/province [6]
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Essen
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Country [7]
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Germany
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State/province [7]
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Muenchen
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Country [8]
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Italy
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State/province [8]
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Napoli
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Country [9]
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Switzerland
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State/province [9]
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Lausanne
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00171730
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00171730
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