Acromegaly
Conditions
Brief summary
Acromegaly is a chronic disease caused by excessive secretion of growth hormone (GH) and mainly due to benign tumour localized in the pituitary gland. The disease develops insidiously, causing a gradual progression of symptoms; consequently most patients are diagnosed in their fourth decade of life. Administration of somatostatin analogues such as lanreotide have been shown to result in normalisation or the decrease of GH and insulin growth factor (IGF-1) levels and improvement of clinical symptoms in acromegalic patients. The purpose of this study is to evaluate whether lanreotide is also effective on tumour volume reduction (tumour shrinkage) and the benefits of this potential tumour shrinkage on disease symptoms and patient's quality of life.
Interventions
12 months
Sponsors
Ipsen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* The patient has given written informed consent prior to any study related procedures * The patient is male or female and is aged between 18 and 75 years, inclusive, * Diagnosis of acromegaly defined by i) GH nadir \> 1 ng/mL as assessed by an oral glucose tolerance test for non diabetic patients (central laboratory results) or a mean GH level \> 1 ng/mL based on 5 samples taken every 10 to 15 minutes for diabetic patients ( central laboratory results) AND ii) IGF-1 concentrations elevated above the age- and sex-matched normal range for diabetic and non diabetic patients (central laboratory results), * The patient has a pituitary adenoma with a diameter greater than or equal to 10 mm based on Magnetic Resonance Imaging (MRI) central reading, * The patient has no visual field defect identified at the visual evaluation, performed by Goldman Visual Fields Analyser and Automated visual field static perimeter, except visual field abnormality at the time of screening and that is in the investigator's Clinical judgement: * Not related to the pituitary adenoma * Clinically stable condition not presumed to change during the study period * Not modifying the ability to evaluate visual field changes related to the macroadenoma
Exclusion criteria
* The patient has a history of hypersensitivity to Lanreotide or drugs with a similar chemical structure, * The patient has received any unlicensed drug within the 30 days prior to the screening visit or is scheduled to receive an unlicensed drug during the course of the study, * The patient is likely to require treatment during the study with somatostatin analogues other than Lanreotide Autogel 120 mg, dopamine agonist, GH receptor antagonist (pegvisomant), and Cyclosporine or drugs that are not permitted by the study protocol, * The patient is a female at risk of pregnancy during the study and is not using acceptable contraceptive methods. Females of childbearing potential must provide a negative pregnancy test at start of study and must be using oral, double barrier (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide), injectable contraception or an intra uterine device. Non childbearing potential is defined as post-menopause for at least 1 year, surgical sterilisation or hysterectomy at least three months before the start of the study, * The patient is pregnant or lactating, * The patient has a history of, or known current, problems with alcohol abuse, * The patient has any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude. * The patient has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardize the patient's safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study, * The patient has undergone pituitary surgery or pituitary radiotherapy prior to study entry, * The patient has previously been treated with a somatostatin analogue, * The patient has received a dopamine agonist or a GH receptor antagonist (pegvisomant) prior to study entry, * The patient is expected to require pituitary surgery (adenomectomy) or to receive radiotherapy during the study period, * Patients with suspected associated prolactinoma: prolactin level \> 100 ng/mL (central laboratory results), * Patient is allergic to Gadolinium (MRI contrast agent) or has acute or chronic severe renal insufficiency (glomerular filtration rate \<30 mL/min/1.73m2), * Patient known by Investigator, to have congenital or acquired optic nerve disease or any visual abnormality with risk of worsening during the course of the study (e.g glaucoma), influencing ability to evaluate Visual Field changes related to the macroadenoma.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Week 1 and Week 48 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of IGF-1 Levels | Week 12, 24, and 48 | — |
| Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Serum GH Levels. | Week 12, 24, and 48 | — |
| Change From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Prolactin Levels | Week 12, 24 and 48 | — |
| Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Arthralgia) From Baseline | Week 12, 24 and 48 | 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. |
| 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). | Baseline (week 1) to week 12 and week 24 | — |
| Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Fatigue) From Baseline | Week 12, 24 and 48 | 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. |
| Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Headache) From Baseline | Week 12, 24 and 48 | 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. |
| Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Soft Tissue Swelling) From Baseline | Week 12, 24 and 48 | 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. |
| Changes in the Global Acromegaly Quality of Life Assessment (AcroQoL) From Baseline | Week 12, 24 and 48 | Acromegaly Quality of Life Assessment (AcroQoL) questionnaire response scores range from 0 to 100. Higher scores indicate best possible Quality of Life. |
| Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Excessive Perspiration) From Baseline | Week 12, 24 and 48 | 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. |
Countries
Belgium, Czechia, Finland, France, Germany, Italy, Netherlands, Turkey (Türkiye), United Kingdom
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 90 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| SCREENING | Screen failure | 18 |
| TREATMENT | Adverse Event | 3 |
| TREATMENT | Lack of Efficacy | 18 |
| TREATMENT | Other (not otherwise specified) | 1 |
| TREATMENT | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Lanreotide Autogel 120 mg |
|---|---|
| Acromegaly Symptoms Arthralgia | 3.5 score on a scale STANDARD_DEVIATION 2.6 |
| Acromegaly Symptoms Excessive perspiration | 4.1 score on a scale STANDARD_DEVIATION 2.4 |
| Acromegaly Symptoms Fatigue | 4.2 score on a scale STANDARD_DEVIATION 2.5 |
| Acromegaly Symptoms Headache | 2.8 score on a scale STANDARD_DEVIATION 2.6 |
| Acromegaly Symptoms Soft tissue swelling | 4.1 score on a scale STANDARD_DEVIATION 2.4 |
| Age, Continuous | 49.5 years STANDARD_DEVIATION 12.4 |
| Global AcroQoL score | 56.4 score on a scale STANDARD_DEVIATION 16.1 |
| Growth Hormone (GH) level | 15.0 mcg/L STANDARD_DEVIATION 18.8 |
| Insulin-like Growth Factor 1 (IGF-1) level | 810 mcg/L STANDARD_DEVIATION 300 |
| Maximum pituitary adenoma diameter (V1) | 19.0 mm STANDARD_DEVIATION 7.1 |
| Pituitary gland MRI volume (V1) | 2739.3 mm^3 STANDARD_DEVIATION 3262.7 |
| Prolactin level | 19.0 mcg/L STANDARD_DEVIATION 20.2 |
| Region of Enrollment Belgium | 2 participants |
| Region of Enrollment Czech Republic | 3 participants |
| Region of Enrollment Finland | 3 participants |
| Region of Enrollment France | 42 participants |
| Region of Enrollment Germany | 10 participants |
| Region of Enrollment Italy | 7 participants |
| Region of Enrollment Netherlands | 4 participants |
| Region of Enrollment Turkey | 2 participants |
| Region of Enrollment United Kingdom | 17 participants |
| Sex: Female, Male Female | 47 Participants |
| Sex: Female, Male Male | 43 Participants |
| Time since acromegaly diagnosis | 121.2 days STANDARD_DEVIATION 149.9 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 72 / 90 |
| serious Total, serious adverse events | 13 / 90 |
Outcome results
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)
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.
Time frame: Week 1 and Week 48
Population: Analysis based on intent-to-treat (ITT) population comprised of 89 patients.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
Secondary
Changes in the Global Acromegaly Quality of Life Assessment (AcroQoL) From Baseline
Acromegaly Quality of Life Assessment (AcroQoL) questionnaire response scores range from 0 to 100. Higher scores indicate best possible Quality of Life.
Time frame: Week 12, 24 and 48
Population: Analysis based on the number (n) of subjects in the ITT population with a valid value.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Lanreotide Autogel 120 mg | Changes in the Global Acromegaly Quality of Life Assessment (AcroQoL) From Baseline | Baseline to week 12 (n=82) | 7.8 units on a scale |
| Lanreotide Autogel 120 mg | Changes in the Global Acromegaly Quality of Life Assessment (AcroQoL) From Baseline | Baseline to week 24 (n=75) | 8.0 units on a scale |
| Lanreotide Autogel 120 mg | Changes in the Global Acromegaly Quality of Life Assessment (AcroQoL) From Baseline | Baseline to week 48 (n=59) | 9.5 units on a scale |
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
Population: Analysis based on number (n) of subjects in the Intent to Treat population (ITT) with a valid value.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Arthralgia) From Baseline
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.
Time frame: Week 12, 24 and 48
Population: Analysis based on the number (n) of subjects in the ITT population with a valid value.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
Secondary
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Excessive Perspiration) From Baseline
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.
Time frame: Week 12, 24 and 48
Population: Analysis based on the number (n) of subjects in the ITT population with a valid value.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
Secondary
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Fatigue) From Baseline
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.
Time frame: Week 12, 24 and 48
Population: Analysis based on the number (n) of subjects in the ITT population with a valid value.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
Secondary
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Headache) From Baseline
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.
Time frame: Week 12, 24 and 48
Population: Analysis based on the number (n) of subjects in the ITT population with a valid value.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
Secondary
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Soft Tissue Swelling) From Baseline
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.
Time frame: Week 12, 24 and 48
Population: Analysis based on the number (n) of subjects in the ITT population with a valid value.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
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
Population: Analysis based on number (n) of patients with a valid value in the intent-to-treat (ITT) population.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
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
Population: Analysis based on number (n) of subjects in the Intent to Treat population (ITT) with a valid value.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |