Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients (HOSCAR)

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT01278342
First received: January 14, 2011
Last updated: April 20, 2011
Last verified: April 2011
Results First Received: January 22, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Acromegaly
Interventions: Drug: Sandostatin LAR
Drug: pegvisomant
Drug: cabergoline

  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
Sandostatin LAR High Dose Alone All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months.
Sandostatin LAR High Dose + Pegvisomat All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months.
Sandostatin LAR High Dose + Cabergoline

All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Cabergoline for a further 4 months, with Cabergoline doses as follows:

  • 1st week: 0.25 mg twice a week (0.50 mg/week)
  • 2nd week: 0.50 mg/week twice a week (1 mg/week)
  • 3rd week: 0.50 mg four times a week (2 mg/week)
  • 4th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)

Participant Flow:   Overall Study
    Sandostatin LAR High Dose Alone     Sandostatin LAR High Dose + Pegvisomat     Sandostatin LAR High Dose + Cabergoline  
STARTED     7     31     32  
COMPLETED     3     30     32  
NOT COMPLETED     4     1     0  
Physician Decision                 0                 1                 0  
Lost to Follow-up                 1                 0                 0  
Administrative problems                 2                 0                 0  
Other                 1                 0                 0  



  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
Sandostatin LAR High Dose Alone All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months.
Sandostatin LAR High Dose + Pegvisomat All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months.
Sandostatin LAR High Dose + Cabergoline

All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Cabergoline for a further 4 months, with Cabergoline doses as follows:

  • 1st week: 0.25 mg twice a week (0.50 mg/week)
  • 2nd week: 0.50 mg/week twice a week (1 mg/week)
  • 3rd week: 0.50 mg four times a week (2 mg/week)
  • 4th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)
Total Total of all reporting groups

Baseline Measures
    Sandostatin LAR High Dose Alone     Sandostatin LAR High Dose + Pegvisomat     Sandostatin LAR High Dose + Cabergoline     Total  
Number of Participants  
[units: participants]
  7     31     32     70  
Age  
[units: years]
Mean ± Standard Deviation
  57.9  ± 7.71     44.6  ± 10.54     49.3  ± 10.50     48.1  ± 10.90  
Gender  
[units: participants]
       
Female     3     17     18     38  
Male     4     14     14     32  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Percentage of Participants With Complete Response (CR) at 8 Months   [ Time Frame: From Baseline to 8 months ]

2.  Secondary:   The Percentage of Participants With Complete Response (CR) At 3 Months   [ Time Frame: From Baseline to 3 months ]

3.  Secondary:   The Percentage of Participants With Partial Response (PR) at 8 Months   [ Time Frame: From Baseline to 8 months ]


  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: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01278342     History of Changes
Other Study ID Numbers: CSMS995BIC03, 2005-005852-42
Study First Received: January 14, 2011
Results First Received: January 22, 2011
Last Updated: April 20, 2011
Health Authority: France: National Consultative Ethics Committee for Health and Life Sciences
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Portugal: Health Ethic Committee
Switzerland: Swissmedic
Poland: Ministry of Health