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Study to Assess the Efficacy of an Extended Injection Interval Schedule of Lanreotide Autogel in Acromegalic Subjects (LEAD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00701363
First received: June 18, 2008
Last updated: November 10, 2015
Last verified: November 2015
Results First Received: September 11, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: 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
Study initiation date: 06-Oct-2008. Study completion date: 20-May-2013. Screened subjects were 128 and screen failure subjects were 4. Subjects treated were 124 and subjects withdrawn early were 17. Subjects completed the study were 107.

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
Phase 1: Lanreotide Autogel 120 mg Subjects in phase 1 received 5 injections of Lanreotide Autogel 120 mg subcutaneously (SC) at baseline and weeks 6, 12, 18 and 24. Baseline and week 24 injections were administered in the investigational centre, whereas the patient could receive weeks 6, 12 and 18 injections at home as part of the subject’s normal medical care, completing details of the injection in the diary cards provided.
Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks Subjects with IGF-1 levels >100% to ≤130% of ULN at week 24 were assigned to group A. These subjects received 5 injections of Lanreotide Autogel 120 mg at 4-week intervals from week 24 up to week 48.
Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks Subjects with IGF-1 levels >50% to ≤100% of ULN at week 24 were assigned to group B. These subjects received 3 injections of Lanreotide Autogel 120 mg at 6-week intervals from week 24 up to week 48.
Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks Subjects with IGF-1 levels ≤50% of ULN at week 24 were assigned to group C. These subjects received 2 injections of Lanreotide Autogel 120 mg at 8-week intervals from week 24 up to week 48.

Participant Flow for 3 periods

Period 1:   Screening (Pre-assignment) Phase
    Phase 1: Lanreotide Autogel 120 mg   Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks   Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks   Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks
STARTED   128   0   0   0 
COMPLETED   124   0   0   0 
NOT COMPLETED   4   0   0   0 
Does not meet entry Criteria                4                0                0                0 

Period 2:   Treatment Phase 1
    Phase 1: Lanreotide Autogel 120 mg   Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks   Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks   Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks
STARTED   124   0   0   0 
COMPLETED   109   0   0   0 
NOT COMPLETED   15   0   0   0 
Does not meet entry Criteria                1                0                0                0 
Adverse Event                7                0                0                0 
Protocol Violation                1                0                0                0 
Withdrawal by Subject                5                0                0                0 
Lack of Efficacy                1                0                0                0 

Period 3:   Treatment Phase 2
    Phase 1: Lanreotide Autogel 120 mg   Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks   Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks   Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks
STARTED   0   13   70   26 
COMPLETED   0   13   68   26 
NOT COMPLETED   0   0   2   0 
Adverse Event                0                0                1                0 
Withdrawal by Subject                0                0                1                0 



  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.
Phase 1: 15 subjects participated only in phase 1 and did not enter in phase 2.

Reporting Groups
  Description
Phase 1: Lanreotide Autogel 120 mg Subjects in phase 1 received 5 injections of Lanreotide Autogel 120 mg subcutaneously (SC) at baseline and weeks 6, 12, 18 and 24. Baseline and week 24 injections were administered in the investigational centre, whereas the patient could receive weeks 6, 12 and 18 injections at home as part of the subject’s normal medical care, completing details of the injection in the diary cards provided.
Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks Subjects with IGF-1 levels >100% to ≤130% of ULN at week 24 were assigned to group A. These subjects received 5 injections of Lanreotide Autogel 120 mg at 4-week intervals from week 24 up to week 48.
Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks Subjects with IGF-1 levels >50% to ≤100% of ULN at week 24 were assigned to group B. These subjects received 3 injections of Lanreotide Autogel 120 mg at 6-week intervals from week 24 up to week 48.
Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks Subjects with IGF-1 levels ≤50% of ULN at week 24 were assigned to group C. These subjects received 2 injections of Lanreotide Autogel 120 mg at 8-week intervals from week 24 up to week 48.
Total Total of all reporting groups

Baseline Measures
   Phase 1: Lanreotide Autogel 120 mg   Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks   Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks   Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   13   70   26   124 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.2  (15.3)   55.0  (10.1)   53.2  (10.4)   57.0  (9.8)   55.4  (10.9) 
Gender 
[Units: Participants]
         
Female   9   8   41   20   78 
Male   6   5   29   6   46 
Region of Enrollment 
[Units: Participants]
         
Russian Federation   1   3   12   4   20 
Korea, Republic of   2   4   7   4   17 
Brazil   2   0   12   1   15 
Serbia   2   3   8   2   15 
France   1   0   9   4   14 
Poland   1   1   8   2   12 
Latvia   1   0   7   2   10 
Greece   2   0   3   4   9 
Sweden   1   0   3   0   4 
Finland   1   1   0   1   3 
Denmark   0   0   0   2   2 
Norway   1   0   0   0   1 
Romania   0   0   1   0   1 
Netherlands   0   1   0   0   1 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation)
 28.4  (2.9)   29.2  (4.1)   29.5  (6.5)   27.0  (4.3)   28.8  (5.6) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Subjects Having Maintained Their Injection Interval Schedule of Six Weeks or Increased Their Injection Interval to Eight Weeks Whilst Keeping Their Normalised Insulin Growth Factor (IGF-1) Levels (Age and Sex Adjusted)   [ Time Frame: At week 48 (End of Study) ]

2.  Secondary:   Percentage of Subjects With Normalised IGF-1 Levels (Age and Sex Adjusted)   [ Time Frame: At week 24 ]

3.  Secondary:   Percentage of Subjects Having Maintained an Injection Interval of Six Weeks or Increasing Their Injection Interval to Eight Weeks   [ Time Frame: During phase 2 of the study (up to week 48) ]

4.  Secondary:   Percentage of Subjects Who Extend Their Injection Interval to Eight Weeks During Phase 2 of the Study, Whilst Maintaining Normalised IGF-1 Levels   [ Time Frame: At week 48 ]

5.  Secondary:   Mean Change From Baseline in IGF-1 Values [Expressed as % of Upper Limit of Normal (ULN)], Overall and by Injection Interval   [ Time Frame: Baseline (visit 1) and week 48 ]

6.  Secondary:   Treatment Group (A, B or C) Mean Baseline IGF-1 Levels (Expressed as % of ULN) in Subjects Who Maintained Normalised IGF-1 Values at Week 48. Comparisons Will be Made as Follows: A Versus B, A Versus C, A Versus (B+C) and B Versus C   [ Time Frame: Baseline (visit 1) ]

7.  Secondary:   Mean Baseline IGF-1 Levels (Expressed as % of ULN) in All Groups (A, B and C) Versus Mean Baseline IGF-1 Levels (Expressed as % of ULN) in Subjects With Uncontrolled IGF-1 Levels at Week 24   [ Time Frame: Baseline (visit 1) ]

8.  Secondary:   Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia)   [ Time Frame: At baseline, week 24 and week 48 ]

9.  Secondary:   Mean Changes From Baseline in Quality of Life Scores (AcroQoL)   [ Time Frame: At weeks 24 and 48 ]

10.  Secondary:   Mean Changes From Baseline in Quality of Life Scores (SF-36)   [ Time Frame: At weeks 24 and 48 ]

11.  Secondary:   Percentage of Subjects With Normalized IGF-1 Levels (Age and Sex Adjusted), Without Any Worsening of the AcroQoL Change Score Between Inclusion and Week 48   [ Time Frame: At week 48 (End of Study) ]

12.  Secondary:   Correlation Between the Changes From Baseline in Quality of Life (AcroQoL) With the Corresponding Changes in IGF-1 Level (Expressed as % of ULN) at Each Visit   [ Time Frame: At weeks 24 and 48 ]

13.  Secondary:   Serum Growth Hormone (GH) Levels   [ Time Frame: At Baseline, week 24 and week 48 ]

14.  Secondary:   Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL   [ Time Frame: At weeks 24 and 48 ]

15.  Secondary:   Subject Treatment Schedule Preference   [ Time Frame: At weeks 24 and 48 ]


  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 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.


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



Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00701363     History of Changes
Other Study ID Numbers: A-38-52030-214
2007-005838-37 ( EudraCT Number )
Study First Received: June 18, 2008
Results First Received: September 11, 2015
Last Updated: November 10, 2015
Health Authority: Sweden: Medical Products Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Latvia: State Agency of Medicines
South Korea: Korea Food and Drug Administration (KFDA)
Russia: Ministry of Health of the Russian Federation
Greece: National Organization of Medicines
Brazil: Ministry of Health
Norway: Norwegian Medicines Agency
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Poland: Ministry of Health
Romania: Ministry of Public Health