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Efficacy/Safety of Octreotide Acetate in Patients With Uncontrolled Acromegaly

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00372697
First received: September 6, 2006
Last updated: April 19, 2011
Last verified: April 2011
Results First Received: January 12, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Acromegaly
Intervention: Drug: Octreotide acetate 30 mg suspension

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Octreotide 30 mg Every 21 Days Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
Octreotide 60 mg Every 28 Days Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.

Participant Flow:   Overall Study
    Octreotide 30 mg Every 21 Days     Octreotide 60 mg Every 28 Days  
STARTED     16     12  
COMPLETED     15     11  
NOT COMPLETED     1     1  
Protocol Violation                 1                 1  



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Octreotide 30 mg Every 21 Days Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
Octreotide 60 mg Every 28 Days Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
Total Total of all reporting groups

Baseline Measures
    Octreotide 30 mg Every 21 Days     Octreotide 60 mg Every 28 Days     Total  
Number of Participants  
[units: participants]
  16     12     28  
Age  
[units: years]
Mean ± Standard Deviation
  51.3  ± 12.1     51.8  ± 15.7     51.5  ± 13.9  
Gender  
[units: participants]
     
Female     10     4     14  
Male     6     8     14  



  Outcome Measures
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1.  Primary:   Change in Growth Hormone (GH) Level From Screening to End of Study (Week 24)   [ Time Frame: Screening to end of study (Week 24) ]

2.  Primary:   Change in Insulin-like Growth Factor 1 (IGF-1) Level From Screening to End of Study (Week 24)   [ Time Frame: Screening to end of study (Week 24) ]

3.  Secondary:   Change in Tumor Volume From Screening to End of Study (Week 24)   [ Time Frame: Screening to end of study (Week 24) ]

4.  Secondary:   Percentage of Participants With > 20% Tumor Shrinkage From Screening to End of Study (Week 24)   [ Time Frame: Screening to end of study (Week 24) ]

5.  Secondary:   Percentage of Participants Asymptomatic for Acromegaly Symptoms at Week 12 and End of Study (Week 24)   [ Time Frame: Week 12 and end of study (Week 24) ]

6.  Secondary:   Acromegaly Quality of Life (AcroQoL) Questionnaire Physical Scale Score at End of Study (Week 24)   [ Time Frame: End of study (Week 24) ]

7.  Secondary:   Acromegaly Quality of Life (AcroQoL) Questionnaire Psychological Scale Score at End of Study (Week 24)   [ Time Frame: End of study (Week 24) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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 by Novartis

Publications automatically indexed to this study:

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00372697     History of Changes
Other Study ID Numbers: CSMS995BIT12
Study First Received: September 6, 2006
Results First Received: January 12, 2011
Last Updated: April 19, 2011
Health Authority: Italy: Ethic Committee of Ospedali Civili di Brescia on behalf of National Health Authority