Trial Outcomes & Findings for Lanreotide as Primary Treatment for Acromegalic Patients With Pituitary Gland Macroadenoma (NCT NCT00690898)
NCT ID: NCT00690898
Last Updated: 2022-10-14
Results Overview
A blinded, centrally assessed evaluation of all MRIs was performed. A 20% reduction from the volume at Visit 1 was considered to be clinically relevant.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
108 participants
Primary outcome timeframe
Week 1 and Week 48
Results posted on
2022-10-14
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
SCREENING
STARTED
|
108
|
|
SCREENING
COMPLETED
|
90
|
|
SCREENING
NOT COMPLETED
|
18
|
|
TREATMENT
STARTED
|
90
|
|
TREATMENT
COMPLETED
|
64
|
|
TREATMENT
NOT COMPLETED
|
26
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
SCREENING
Screen failure
|
18
|
|
TREATMENT
Adverse Event
|
3
|
|
TREATMENT
Lack of Efficacy
|
18
|
|
TREATMENT
Withdrawal by Subject
|
4
|
|
TREATMENT
Other (not otherwise specified)
|
1
|
Baseline Characteristics
Lanreotide as Primary Treatment for Acromegalic Patients With Pituitary Gland Macroadenoma
Baseline characteristics by cohort
| Measure |
Lanreotide Autogel 120 mg
n=90 Participants
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.
|
|---|---|
|
Age, Continuous
|
49.5 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
42 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
17 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Finland
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
2 participants
n=5 Participants
|
|
Maximum pituitary adenoma diameter (V1)
|
19.0 mm
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
Acromegaly Symptoms
Headache
|
2.8 score on a scale
STANDARD_DEVIATION 2.6 • n=5 Participants
|
|
Acromegaly Symptoms
Excessive perspiration
|
4.1 score on a scale
STANDARD_DEVIATION 2.4 • n=5 Participants
|
|
Acromegaly Symptoms
Fatigue
|
4.2 score on a scale
STANDARD_DEVIATION 2.5 • n=5 Participants
|
|
Acromegaly Symptoms
Soft tissue swelling
|
4.1 score on a scale
STANDARD_DEVIATION 2.4 • n=5 Participants
|
|
Acromegaly Symptoms
Arthralgia
|
3.5 score on a scale
STANDARD_DEVIATION 2.6 • n=5 Participants
|
|
Time since acromegaly diagnosis
|
121.2 days
STANDARD_DEVIATION 149.9 • n=5 Participants
|
|
Pituitary gland MRI volume (V1)
|
2739.3 mm^3
STANDARD_DEVIATION 3262.7 • n=5 Participants
|
|
Growth Hormone (GH) level
|
15.0 mcg/L
STANDARD_DEVIATION 18.8 • n=5 Participants
|
|
Insulin-like Growth Factor 1 (IGF-1) level
|
810 mcg/L
STANDARD_DEVIATION 300 • n=5 Participants
|
|
Prolactin level
|
19.0 mcg/L
STANDARD_DEVIATION 20.2 • n=5 Participants
|
|
Global AcroQoL score
|
56.4 score on a scale
STANDARD_DEVIATION 16.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 1 and Week 48Population: Analysis based on intent-to-treat (ITT) population comprised of 89 patients.
A blinded, centrally assessed evaluation of all MRIs was performed. A 20% reduction from the volume at Visit 1 was considered to be clinically relevant.
Outcome measures
| Measure |
Lanreotide Autogel 120 mg
n=89 Participants
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.
|
|---|---|
|
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)
Greater than or equal to 20%
|
62.9 percentage of subjects
Interval 52.0 to 72.9
|
|
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)
Less than 20%
|
37.1 percentage of subjects
Interval 27.1 to 48.0
|
SECONDARY outcome
Timeframe: Baseline (week 1) to week 12 and week 24Population: Analysis based on number (n) of subjects in the Intent to Treat population (ITT) with a valid value.
Outcome measures
| Measure |
Lanreotide Autogel 120 mg
n=89 Participants
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.
|
|---|---|
|
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).
Greater than or equal to 20% at week 12 (n=85)
|
46 participants
Interval 44.7 to 67.3
|
|
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).
Less than 20% at week 12 (n=85)
|
39 participants
Interval 43.0 to 65.0
|
|
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).
Greater than or equal to 20% at week 24 (n=80)
|
45 participants
|
|
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).
Less than 20% at week 24 (n=80)
|
35 participants
|
SECONDARY outcome
Timeframe: Week 12, 24, and 48Population: Analysis based on number (n) of patients with a valid value in the intent-to-treat (ITT) population.
Outcome measures
| Measure |
Lanreotide Autogel 120 mg
n=89 Participants
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.
|
|---|---|
|
Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of IGF-1 Levels
Week 48 (n=62)
|
-56.7 percentage change
Interval -62.1 to -51.3
|
|
Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of IGF-1 Levels
Week 12 (n=85)
|
-43.8 percentage change
Interval -50.1 to -37.5
|
|
Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of IGF-1 Levels
Week 24 (n=78)
|
-47.4 percentage change
Interval -53.6 to -41.2
|
SECONDARY outcome
Timeframe: Week 12, 24, and 48Population: Analysis based on number (n) of subjects in the Intent to Treat population (ITT) with a valid value.
Outcome measures
| Measure |
Lanreotide Autogel 120 mg
n=85 Participants
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.
|
|---|---|
|
Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Serum GH Levels.
Week 12 (n=85)
|
-62.1 percentage change
Interval -70.5 to -53.6
|
|
Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Serum GH Levels.
Week 24 (n=78)
|
-64.6 percentage change
Interval -72.3 to -57.0
|
|
Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Serum GH Levels.
Week 48 (n=63)
|
-70.9 percentage change
Interval -79.2 to -62.5
|
SECONDARY outcome
Timeframe: Week 12, 24 and 48Population: Analysis based on the number (n) of subjects with baseline level between 20 ng/ml and 100 ng/ml in the ITT population with a valid value.
Outcome measures
| Measure |
Lanreotide Autogel 120 mg
n=21 Participants
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.
|
|---|---|
|
Change From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Prolactin Levels
Prolactin levels at baseline (n=21)
|
48.0 mcg/L
Standard Deviation 24.4
|
|
Change From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Prolactin Levels
Change From Baseline to Week 12 (n=20)
|
-18.0 mcg/L
Standard Deviation 19.0 • Interval -26.9 to -9.1
|
|
Change From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Prolactin Levels
Change From Baseline to Week 24 (n=20)
|
-18.6 mcg/L
Standard Deviation 20.3 • Interval -28.1 to -9.1
|
|
Change From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Prolactin Levels
Change From Baseline to Week 48 (n=12)
|
-17.3 mcg/L
Standard Deviation 18.4 • Interval -29.0 to -5.6
|
SECONDARY outcome
Timeframe: Week 12, 24 and 48Population: Analysis based on the number (n) of subjects in the ITT population with a valid value.
The status of clinical signs of acromegaly assessed by an acromegaly symptoms questionnaire (paper form) completed by the patient at each study visit. The scoring for each clinical sign of acromegaly on the questionnaire is from 0 (no symptom) to 8 (severe, incapacitating symptom). The variation (or no variation) in scores indicate whether the clinical sign of acromegaly had improved, worsened or was unchanged.
Outcome measures
| Measure |
Lanreotide Autogel 120 mg
n=89 Participants
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.
|
|---|---|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Arthralgia) From Baseline
Baseline to week 12 - Worsened (n=88)
|
9.1 percentage of subjects
Interval 3.1 to 15.1
|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Arthralgia) From Baseline
Baseline to week 12 - Unchanged (n=88)
|
26.1 percentage of subjects
Interval 17.0 to 35.3
|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Arthralgia) From Baseline
Baseline to week 12 - Improved (n=88)
|
64.8 percentage of subjects
Interval 54.8 to 74.8
|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Arthralgia) From Baseline
Baseline to week 24 - Worsened (n=81)
|
11.1 percentage of subjects
Interval 4.3 to 18.0
|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Arthralgia) From Baseline
Baseline to week 24 - Unchanged (n=81)
|
24.7 percentage of subjects
Interval 15.3 to 34.1
|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Arthralgia) From Baseline
Baseline to week 24 - Improved (n=81)
|
64.2 percentage of subjects
Interval 53.8 to 74.6
|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Arthralgia) From Baseline
Baseline to week 48 - Worsened (n=62)
|
17.7 percentage of subjects
Interval 8.2 to 27.3
|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Arthralgia) From Baseline
Baseline to week 48 - Unchanged (n=62)
|
22.6 percentage of subjects
Interval 12.2 to 33.0
|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Arthralgia) From Baseline
Baseline to week 48 - Improved (n=62)
|
59.7 percentage of subjects
Interval 47.5 to 71.9
|
SECONDARY outcome
Timeframe: Week 12, 24 and 48Population: Analysis based on the number (n) of subjects in the ITT population with a valid value.
The status of clinical signs of acromegaly assessed by an acromegaly symptoms questionnaire (paper form) completed by the patient at each study visit. The scoring for each clinical sign of acromegaly on the questionnaire is from 0 (no symptom) to 8 (severe, incapacitating symptom). The variation (or no variation) in scores indicate whether the clinical sign of acromegaly had improved, worsened or was unchanged.
Outcome measures
| Measure |
Lanreotide Autogel 120 mg
n=88 Participants
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.
|
|---|---|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Excessive Perspiration) From Baseline
Baseline to week 12 - Worsened (n=88)
|
11.4 percentage of subjects
Interval 4.7 to 18.0
|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Excessive Perspiration) From Baseline
Baseline to week 12 - Unchanged (n=88)
|
25.0 percentage of subjects
Interval 16.0 to 34.0
|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Excessive Perspiration) From Baseline
Baseline to week 12 - Improved (n=88)
|
63.6 percentage of subjects
Interval 53.6 to 73.7
|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Excessive Perspiration) From Baseline
Baseline to week 24 - Worsened (n=81)
|
14.8 percentage of subjects
Interval 7.1 to 22.6
|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Excessive Perspiration) From Baseline
Baseline to week 24 - Unchanged (n=81)
|
21.0 percentage of subjects
Interval 12.1 to 29.9
|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Excessive Perspiration) From Baseline
Baseline to week 24 - Improved (n=81)
|
64.2 percentage of subjects
Interval 53.8 to 74.6
|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Excessive Perspiration) From Baseline
Baseline to week 48 - Worsened (n=62)
|
9.7 percentage of subjects
Interval 2.3 to 17.0
|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Excessive Perspiration) From Baseline
Baseline to week 48 - Unchanged (n=62)
|
24.2 percentage of subjects
Interval 13.5 to 34.9
|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Excessive Perspiration) From Baseline
Baseline to week 48 - Improved (n=62)
|
66.1 percentage of subjects
Interval 54.3 to 77.9
|
SECONDARY outcome
Timeframe: Week 12, 24 and 48Population: Analysis based on the number (n) of subjects in the ITT population with a valid value.
The status of clinical signs of acromegaly assessed by an acromegaly symptoms questionnaire (paper form) completed by the patient at each study visit. The scoring for each clinical sign of acromegaly on the questionnaire is from 0 (no symptom) to 8 (severe, incapacitating symptom). The variation (or no variation) in scores indicate whether the clinical sign of acromegaly had improved, worsened or was unchanged.
Outcome measures
| Measure |
Lanreotide Autogel 120 mg
n=88 Participants
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.
|
|---|---|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Fatigue) From Baseline
Baseline to week 12 - Worsened (n=88)
|
13.6 percentage of subjects
Interval 6.5 to 20.8
|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Fatigue) From Baseline
Baseline to week 12 - Unchanged (n=88)
|
25.0 percentage of subjects
Interval 16.0 to 34.0
|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Fatigue) From Baseline
Baseline to week 12 - Improved (n=88)
|
61.4 percentage of subjects
Interval 51.2 to 71.5
|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Fatigue) From Baseline
Baseline to week 24 - Worsened (n=81)
|
16.0 percentage of subjects
Interval 8.1 to 24.0
|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Fatigue) From Baseline
Baseline to week 24 - Unchanged (n=81)
|
17.3 percentage of subjects
Interval 9.0 to 25.5
|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Fatigue) From Baseline
Baseline to week 24 - Improved (n=81)
|
66.7 percentage of subjects
Interval 56.4 to 76.9
|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Fatigue) From Baseline
Baseline to week 48 - Worsened (n=62)
|
14.5 percentage of subjects
Interval 5.7 to 23.3
|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Fatigue) From Baseline
Baseline to week 48 - Unchanged (n=62)
|
29.0 percentage of subjects
Interval 17.7 to 40.3
|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Fatigue) From Baseline
Baseline to week 48 - Improved (n=62)
|
56.5 percentage of subjects
Interval 44.1 to 68.8
|
SECONDARY outcome
Timeframe: Week 12, 24 and 48Population: Analysis based on the number (n) of subjects in the ITT population with a valid value.
The status of clinical signs of acromegaly assessed by an acromegaly symptoms questionnaire (paper form) completed by the patient at each study visit. The scoring for each clinical sign of acromegaly on the questionnaire is from 0 (no symptom) to 8 (severe, incapacitating symptom). The variation (or no variation) in scores indicate whether the clinical sign of acromegaly had improved, worsened or was unchanged.
Outcome measures
| Measure |
Lanreotide Autogel 120 mg
n=88 Participants
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.
|
|---|---|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Headache) From Baseline
Baseline to week 12 - Worsened (n=88)
|
13.6 percentage of subjects
Interval 6.5 to 20.8
|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Headache) From Baseline
Baseline to week 12 - Unchanged (n=88)
|
46.6 percentage of subjects
Interval 36.2 to 57.0
|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Headache) From Baseline
Baseline to week 12 - Improved (n=88)
|
39.8 percentage of subjects
Interval 29.5 to 50.0
|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Headache) From Baseline
Baseline to week 24 - Worsened (n=81)
|
11.1 percentage of subjects
Interval 4.3 to 18.0
|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Headache) From Baseline
Baseline to week 24 - Unchanged (n=81)
|
42.0 percentage of subjects
Interval 31.2 to 52.7
|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Headache) From Baseline
Baseline to week 24 - Improved (n=81)
|
46.9 percentage of subjects
Interval 36.0 to 57.8
|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Headache) From Baseline
Baseline to week 48 - Worsened (n=62)
|
14.5 percentage of subjects
Interval 5.7 to 23.3
|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Headache) From Baseline
Baseline to week 48 - Unchanged (n=62)
|
46.8 percentage of subjects
Interval 34.4 to 59.2
|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Headache) From Baseline
Baseline to week 48 - Improved (n=62)
|
38.7 percentage of subjects
Interval 26.6 to 50.8
|
SECONDARY outcome
Timeframe: Week 12, 24 and 48Population: Analysis based on the number (n) of subjects in the ITT population with a valid value.
The status of clinical signs of acromegaly assessed by an acromegaly symptoms questionnaire (paper form) completed by the patient at each study visit. The scoring for each clinical sign of acromegaly on the questionnaire is from 0 (no symptom) to 8 (severe, incapacitating symptom). The variation (or no variation) in scores indicate whether the clinical sign of acromegaly had improved, worsened or was unchanged.
Outcome measures
| Measure |
Lanreotide Autogel 120 mg
n=88 Participants
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.
|
|---|---|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Soft Tissue Swelling) From Baseline
Baseline to week 12 - Worsened (n=88)
|
10.2 percentage of subjects
Interval 3.9 to 16.6
|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Soft Tissue Swelling) From Baseline
Baseline to week 12 - Unchanged (n=88)
|
26.1 percentage of subjects
Interval 17.0 to 35.3
|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Soft Tissue Swelling) From Baseline
Baseline to week 12 - Improved (n=88)
|
63.6 percentage of subjects
Interval 53.6 to 73.7
|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Soft Tissue Swelling) From Baseline
Baseline to week 24 - Worsened (n=81)
|
11.1 percentage of subjects
Interval 4.3 to 18.0
|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Soft Tissue Swelling) From Baseline
Baseline to week 24 - Unchanged (n=81)
|
22.2 percentage of subjects
Interval 13.2 to 31.3
|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Soft Tissue Swelling) From Baseline
Baseline to week 24 - Improved (n=81)
|
66.7 percentage of subjects
Interval 56.4 to 76.9
|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Soft Tissue Swelling) From Baseline
Baseline to week 48 - Worsened (n=62)
|
14.5 percentage of subjects
Interval 5.7 to 23.3
|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Soft Tissue Swelling) From Baseline
Baseline to week 48 - Unchanged (n=62)
|
19.4 percentage of subjects
Interval 9.5 to 29.2
|
|
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Soft Tissue Swelling) From Baseline
Baseline to week 48 - Improved (n=62)
|
66.1 percentage of subjects
Interval 54.3 to 77.9
|
SECONDARY outcome
Timeframe: Week 12, 24 and 48Population: Analysis based on the number (n) of subjects in the ITT population with a valid value.
Acromegaly Quality of Life Assessment (AcroQoL) questionnaire response scores range from 0 to 100. Higher scores indicate best possible Quality of Life.
Outcome measures
| Measure |
Lanreotide Autogel 120 mg
n=84 Participants
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.
|
|---|---|
|
Changes in the Global Acromegaly Quality of Life Assessment (AcroQoL) From Baseline
Baseline to week 12 (n=82)
|
7.8 units on a scale
Interval 5.7 to 9.8
|
|
Changes in the Global Acromegaly Quality of Life Assessment (AcroQoL) From Baseline
Baseline to week 24 (n=75)
|
8.0 units on a scale
Interval 5.3 to 10.8
|
|
Changes in the Global Acromegaly Quality of Life Assessment (AcroQoL) From Baseline
Baseline to week 48 (n=59)
|
9.5 units on a scale
Interval 6.2 to 12.8
|
Adverse Events
Lanreotide Autogel 120 mg
Serious events: 13 serious events
Other events: 72 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lanreotide Autogel 120 mg
n=90 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
1/90 • Number of events 1 • Four years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.1%
1/90 • Number of events 1 • Four years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.1%
1/90 • Number of events 1 • Four years
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.1%
1/90 • Number of events 1 • Four years
|
|
Endocrine disorders
Hyperparathyroidism
|
1.1%
1/90 • Number of events 1 • Four years
|
|
Surgical and medical procedures
Hypophysectomy
|
1.1%
1/90 • Number of events 1 • Four years
|
|
General disorders
Hypothermia
|
1.1%
1/90 • Number of events 1 • Four years
|
|
Investigations
Insulin-like growth factor increased
|
1.1%
1/90 • Number of events 1 • Four years
|
|
Nervous system disorders
Intracranial hypotension
|
1.1%
1/90 • Number of events 1 • Four years
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.1%
1/90 • Number of events 1 • Four years
|
|
Reproductive system and breast disorders
Ovarian cyst
|
1.1%
1/90 • Number of events 1 • Four years
|
|
Investigations
Oxygen saturation decreased
|
1.1%
1/90 • Number of events 1 • Four years
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
1.1%
1/90 • Number of events 1 • Four years
|
|
Renal and urinary disorders
Renal colic
|
1.1%
1/90 • Number of events 1 • Four years
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
1.1%
1/90 • Number of events 2 • Four years
|
|
Nervous system disorders
Syncope
|
2.2%
2/90 • Number of events 2 • Four years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
1.1%
1/90 • Number of events 1 • Four years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
1.1%
1/90 • Number of events 1 • Four years
|
|
Eye disorders
Visual acuity reduced
|
1.1%
1/90 • Number of events 1 • Four years
|
Other adverse events
| Measure |
Lanreotide Autogel 120 mg
n=90 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
9/90 • Number of events 16 • Four years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
13.3%
12/90 • Number of events 12 • Four years
|
|
Hepatobiliary disorders
Cholelithiasis 6 (6.7%) [7]
|
6.7%
6/90 • Number of events 7 • Four years
|
|
Gastrointestinal disorders
Diarrhoea
|
38.9%
35/90 • Number of events 98 • Four years
|
|
General disorders
Fatigue
|
5.6%
5/90 • Number of events 5 • Four years
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
11.1%
10/90 • Number of events 16 • Four years
|
|
Gastrointestinal disorders
Nausea
|
6.7%
6/90 • Number of events 14 • Four years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place