Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00600886
First received: January 14, 2008
Last updated: January 28, 2015
Last verified: January 2015
Results First Received: December 19, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Acromegaly
Interventions: Drug: Pasireotide
Drug: Octreotide

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pasireotide LAR up to 26 Months Patients in this arm received Pasireotide LAR 40 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Patients who did not respond to their randomized treatment (i.e. Pasireotide LAR ) at the end of the core (Month 12) were allowed to switch to receive the other treatment in the extension, and those who were responders continued with the same treatment as in the core at the discretion of the investigator. Dose could be down- or up-titrated to 20 or 60 mg, respectively.
Octreotide LAR (Core) Followed by Pasireotide LAR (Extension) Patients in this arm received Octreotide LAR 20 im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Patients who did not respond to their randomized treatment (Octreotide LAR) at the end of the core (Month 12) were allowed to switch to receive the other treatment in the extension, and those who were responders continued with the same treatment as in the core at the discretion of the investigator (up to 2 years of treatment). Dose could be down- or up-titrated to 10 or 30 mg, respectively.

Participant Flow for 3 periods

Period 1:   Core Phase - Full Analysis Set
    Pasireotide LAR up to 26 Months     Octreotide LAR (Core) Followed by Pasireotide LAR (Extension)  
STARTED     176     182  
Did Not Enter Extension     29     29  
Entered Extension, Crossed Over     38     81  
Entered Ext Continued Same Treatment     74     46  
COMPLETED     141 [1]   156 [1]
NOT COMPLETED     35     26  
Adverse Event                 14                 6  
Protocol Violation                 7                 8  
Lack of Efficacy                 5                 8  
Withdrawal by Subject                 5                 3  
Administrative Problems                 2                 0  
Abnormal laboratory value(s)                 1                 0  
Lost to Follow-up                 1                 0  
Death                 0                 1  
[1] Completed = anyone who did not discontinue prior to month 12.

Period 2:   Ext Month 12 - 26 Same Treatment
    Pasireotide LAR up to 26 Months     Octreotide LAR (Core) Followed by Pasireotide LAR (Extension)  
STARTED     74     46  
Completed Study at Month 26     0     31  
Continued Beyond Month 26     51     5  
COMPLETED     51 [1]   36 [1]
NOT COMPLETED     23     10  
Withdrawal by Subject                 9                 2  
Lack of Efficacy                 3                 3  
Administrative Problems                 3                 2  
Lost to Follow-up                 3                 1  
Adverse Event                 2                 1  
Abnormal Lab Value (s)                 2                 0  
Death                 1                 1  
[1] Completed Month 12 and continued beyond Month 26.

Period 3:   Extension-start of Crossover to Month 26
    Pasireotide LAR up to 26 Months     Octreotide LAR (Core) Followed by Pasireotide LAR (Extension)  
STARTED     81     38  
Completed Study at Month 26     0     25  
Continued Beyond Month 26     50     0  
COMPLETED     50 [1]   25 [1]
NOT COMPLETED     31     13  
Adverse Event                 12                 1  
Withdrawal by Subject                 8                 4  
Lack of Efficacy                 7                 4  
Administrative Problems                 1                 4  
Subject no longer requires study drug                 2                 0  
Abnormal Lab Value (s)                 1                 0  
[1] Completed and continued beyond month 26.



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Paseriotide LAR Patients in this arm received Octreotide LAR 20 im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Patients who did not respond to their randomized treatment (i.e. Pasireotide LAR or Octreotide LAR) at the end of the core (Month 12) were allowed to switch to receive the other treatment in the extension, and those who were responders continued with the same treatment as in the core at the discretion of the investigator (up to 2 years of treatment). Dose could be down- or up-titrated to 10 or 30 mg, respectively.
Octreotide LAR up to 26 Months Patients in this arm received Octreotide LAR 20 im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Patients who did not respond to their randomized treatment (Octreotide LAR) at the end of the core (Month 12) were allowed to switch to receive the other treatment in the extension, and those who were responders continued with the same treatment as in the core at the discretion of the investigator (up to 2 years of treatment). Dose could be down- or up-titrated to 10 or 30 mg, respectively.
Total Total of all reporting groups

Baseline Measures
    Paseriotide LAR     Octreotide LAR up to 26 Months     Total  
Number of Participants  
[units: participants]
  176     182     358  
Age, Customized  
[units: Participants]
     
<65 Years     168     167     335  
>=65 years     8     15     23  
Gender  
[units: Participants]
     
Female     91     95     186  
Male     85     87     172  



  Outcome Measures

1.  Primary:   Compare the Proportion of Patients With a Reduction of Mean GH Level to <2.5 ug/L and the Normalization of IGF-1 Between the Two Teatments Groups   [ Time Frame: 12 months ]

2.  Secondary:   Effect of Pasireotide LAR vs. Octreotide LAR on Reduction of GH to <2.5 ug/L Alone   [ Time Frame: 12 Months ]
Results not yet reported.   Anticipated Reporting Date:   03/2015   Safety Issue:   No

3.  Secondary:   Effect of Pasireotide LAR vs. Octreotide LAR on Tumor Volume   [ Time Frame: 12 Months ]
Results not yet reported.   Anticipated Reporting Date:   03/2015   Safety Issue:   No

4.  Secondary:   Effect of Pasireotide LAR vs. Octreotide LAR on Health Related Quality of Life   [ Time Frame: 12 Months ]
Results not yet reported.   Anticipated Reporting Date:   03/2015   Safety Issue:   No

5.  Secondary:   Effect of Pasireotide LAR vs. Octreotide LAR as Long Term Treatment and After Cross-over on the Proportion of Patients With a Reduction of Mean GH Level to <2.5 ug/L and Nomalization of IGF-1 to Within Normal Limits (Age and Sex Related)   [ Time Frame: 12 Months ]
Results not yet reported.   Anticipated Reporting Date:   03/2015   Safety Issue:   No

6.  Secondary:   Effect of Pasireotide LAR and Octreotide LAR as Long Term Treatment and After Cross Over on (i)GH<2.5 ug/L and (ii) Normalized IGF-1   [ Time Frame: 12 Months ]
Results not yet reported.   Anticipated Reporting Date:   03/2015   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


No publications provided


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00600886     History of Changes
Other Study ID Numbers: CSOM230C2305, 2007-001972-36
Study First Received: January 14, 2008
Results First Received: December 19, 2014
Last Updated: January 28, 2015
Health Authority: United States: Food and Drug Administration
Argentina: Ministry of Health
Australia: Department of Health
Belgium: Ministry of Social Affairs, Public Health and the Environment
Brazil: National Health Surveillance Agency
Canada: Food Inspection Agency
China: Ministry of Health
Colombia: Institutional Review Board
Czech Republic: Ministry of Health
Denmark: Ministry of Health
France: Ministry of Health
Greece: Ministry of Health and Welfare
Germany: Ministry of Health
Hungary: National Institute of Pharmacy
Israel: Ministry of Health
Italy: Ministry of Health
Korea, Republic of: Food and Drug Administration
Mexico: Ministry of Health
Netherlands: Ministry of Health, Welfare and Sports
Norway: Norwegian Medicines Agency
Poland: Ministry of Health and Social Security
Portugal: Ministry of Health
Russia: Ministry of Public health
Spain: Ministry of Health and Consumption
Sweden: Medical Products Agency
Switzerland: Ethikkommission
Turkey: Ministry of Health
Taiwan: Department of Health
United Kingdom: Health Protection Agency
Venezuela: Ministry of Health and Social Development