Lanreotide as Primary Treatment for Acromegalic Patients With Pituitary Gland Macroadenoma (PRIMARYS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00690898
First received: June 3, 2008
Last updated: February 27, 2014
Last verified: February 2014
Results First Received: November 4, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Acromegaly
Intervention: Drug: Lanreotide autogel 120 mg

  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
Newly diagnosed acromegaly patients with pituitary tumour were recruited at 27 investigational sites in 9 countries namely Belgium, Finland, France, Czech Republic, Germany, Italy, the Netherlands, Turkey and the United Kingdom.

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
Lanreotide Autogel 120 mg One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.

Participant Flow for 2 periods

Period 1:   SCREENING
    Lanreotide Autogel 120 mg  
STARTED     108 [1]
COMPLETED     90 [2]
NOT COMPLETED     18  
Screen failure                 18  
[1] Total of patients screened for the study.
[2] Number of patients included in the study.

Period 2:   TREATMENT
    Lanreotide Autogel 120 mg  
STARTED     90 [1]
COMPLETED     64  
NOT COMPLETED     26  
Adverse Event                 3  
Lack of Efficacy                 18  
Withdrawal by Subject                 4  
Other (not otherwise specified)                 1  
[1] Total number of patients treated.



  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.
No text entered.

Reporting Groups
  Description
Lanreotide Autogel 120 mg One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.

Baseline Measures
    Lanreotide Autogel 120 mg  
Number of Participants  
[units: participants]
  90  
Age  
[units: years]
Mean ± Standard Deviation
  49.5  ± 12.4  
Gender  
[units: participants]
 
Female     47  
Male     43  
Region of Enrollment  
[units: participants]
 
France     42  
United Kingdom     17  
Germany     10  
Italy     7  
Netherlands     4  
Czech Republic     3  
Finland     3  
Belgium     2  
Turkey     2  
Maximum pituitary adenoma diameter (V1)  
[units: mm]
Mean ± Standard Deviation
  19.0  ± 7.1  
Acromegaly Symptoms [1]
[units: score on a scale]
Mean ± Standard Deviation
 
Headache     2.8  ± 2.6  
Excessive perspiration     4.1  ± 2.4  
Fatigue     4.2  ± 2.5  
Soft tissue swelling     4.1  ± 2.4  
Arthralgia     3.5  ± 2.6  
Time since acromegaly diagnosis  
[units: days]
Mean ± Standard Deviation
  121.2  ± 149.9  
Pituitary gland MRI volume (V1)  
[units: mm^3]
Mean ± Standard Deviation
  2739.3  ± 3262.7  
Growth Hormone (GH) level  
[units: mcg/L]
Mean ± Standard Deviation
  15.0  ± 18.8  
Insulin-like Growth Factor 1 (IGF-1) level  
[units: mcg/L]
Mean ± Standard Deviation
  810  ± 300  
Prolactin level  
[units: mcg/L]
Mean ± Standard Deviation
  19.0  ± 20.2  
Global AcroQoL score [2]
[units: score on a scale]
Mean ± Standard Deviation
  56.4  ± 16.1  
[1] Acromegaly symptoms assessed on a scale of 0 to 8 (0- no symptoms to 8-severe/incapacitating).
[2] Acromegaly Quality of Life Assessment (AcroQoL) questionnaire response scores range from 0 to 100. Higher scores indicate best possible Quality of Life. AcroQoL not assessed in patients from Turkey and Finland.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Patients With Relevant Reduction in Pituitary Tumour Volume (as Measured by MRI) From Baseline Volume (Visit 1) to Week 48 (After 12 Injections at Visit 5)   [ Time Frame: Week 1 and Week 48 ]

2.  Secondary:   Number of Patients With at Least a 20% Reduction in Tumour Volume From Baseline Volume (Visit 1) to Week 12 (Visit 3) and Week 24 (Visit 4).   [ Time Frame: Baseline (week 1) to week 12 and week 24 ]

3.  Secondary:   Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of IGF-1 Levels   [ Time Frame: Week 12, 24, and 48 ]

4.  Secondary:   Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Serum GH Levels.   [ Time Frame: Week 12, 24, and 48 ]

5.  Secondary:   Change From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Prolactin Levels   [ Time Frame: Week 12, 24 and 48 ]

6.  Secondary:   Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Arthralgia) From Baseline   [ Time Frame: Week 12, 24 and 48 ]

7.  Secondary:   Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Excessive Perspiration) From Baseline   [ Time Frame: Week 12, 24 and 48 ]

8.  Secondary:   Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Fatigue) From Baseline   [ Time Frame: Week 12, 24 and 48 ]

9.  Secondary:   Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Headache) From Baseline   [ Time Frame: Week 12, 24 and 48 ]

10.  Secondary:   Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Soft Tissue Swelling) From Baseline   [ Time Frame: Week 12, 24 and 48 ]

11.  Secondary:   Changes in the Global Acromegaly Quality of Life Assessment (AcroQoL) From Baseline   [ Time Frame: Week 12, 24 and 48 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


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.  


Results Point of Contact:  
Name/Title: Medical Director, Endocrinology
Organization: Ipsen
phone: clinical.trials@ipsen.com
e-mail: clinical.trials@ipsen.com


Publications of Results:

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00690898     History of Changes
Other Study ID Numbers: 2-79-52030-207, 2007-000155-34
Study First Received: June 3, 2008
Results First Received: November 4, 2013
Last Updated: February 27, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Germany: Ministry of Health
Sweden: Medical Products Agency
Czech Republic: State Institute for Drug Control
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Finland: Finnish Medicines Agency
Turkey: Ministry of Health
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency