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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
2004-002849-12
Secondary ID [2] 0 0
CSOM230B2201E1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acromegaly 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Growth Hormone (GH) and Insulin-like Growth Factor 1 (IGF-1) Observed Response by Dose Class
Timepoint [1] 0 0
Month 9 (Month 9 visit is at the completion of six months in this extension study)
Secondary outcome [1] 0 0
Time to Tumor Response
Timepoint [1] 0 0
Core study baseline to at least a 20% decrease in pituitary tumor volume (up to approximately 114 months)
Secondary outcome [2] 0 0
Summary Magnetic Resonance Imaging (MRI) Pituitary Tumor Volumes
Timepoint [2] 0 0
Core study baseline, Months 9, 27, 63, 75 and 99
Secondary outcome [3] 0 0
Percentage of Participants With Symptoms of Acromegaly
Timepoint [3] 0 0
Core study baseline till the last assessment of the extension study (up to approximately 114 months)
Secondary outcome [4] 0 0
Percentage of Participants With Sleep Apnea Symptoms as Assessed by Epworth Sleepiness Scale by Situation
Timepoint [4] 0 0
Core study baseline till the last assessment of the extension study (up to approximately 114 months)
Secondary outcome [5] 0 0
Percentage of Participants With One or More Adverse Events (AEs)
Timepoint [5] 0 0
From start of study drug treatment up to end of study (approximately 111 months)

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.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/08/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/12/2013
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Novartis Investigative Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
Belgium
State/province [4] 0 0
Edegem
Country [5] 0 0
France
State/province [5] 0 0
Toulouse Cédex 4
Country [6] 0 0
Germany
State/province [6] 0 0
Essen
Country [7] 0 0
Germany
State/province [7] 0 0
Muenchen
Country [8] 0 0
Italy
State/province [8] 0 0
Napoli
Country [9] 0 0
Switzerland
State/province [9] 0 0
Lausanne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Petersenn S, Farrall AJ, De Block C, Melmed S, Sch... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT00171730