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)
| Group | Value (percentage of subjects) |
|---|---|
| Lanreotide Autogel 120 mg | 62.9 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataShort name PRIMARYS
Belgium, Czechia, Finland, France, Germany, Italy, Netherlands, Turkey (Türkiye), United Kingdom
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Experimental
Lanreotide autogel 120 mg
Outcomes the sponsor listed as 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
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.
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
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
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
Change From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Prolactin Levels
Time frame · Week 12, 24 and 48
Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Arthralgia) From Baseline
Time frame · 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 (Excessive Perspiration) From Baseline
Time frame · 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 (Fatigue) From Baseline
Time frame · 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
Time frame · 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
Time frame · 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
Time frame · 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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percentage of subjects) |
|---|---|
| Lanreotide Autogel 120 mg | 62.9 |
| Group | Value (participants) |
|---|---|
| Lanreotide Autogel 120 mg | 46 |
| Group | Value (percentage change) |
|---|---|
| Lanreotide Autogel 120 mg | -43.8 |
| Group | Value (percentage change) |
|---|---|
| Lanreotide Autogel 120 mg | -62.1 |
| Group | Value (mcg/L) | Spread |
|---|---|---|
| Lanreotide Autogel 120 mg | 48.0 | 24.4 |
| Group | Value (percentage of subjects) |
|---|---|
| Lanreotide Autogel 120 mg | 9.1 |
| Group | Value (percentage of subjects) |
|---|---|
| Lanreotide Autogel 120 mg | 11.4 |
| Group | Value (percentage of subjects) |
|---|---|
| Lanreotide Autogel 120 mg | 13.6 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Lanreotide Autogel 120 mgOne 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. | – | 13 / 90 | 72 / 90 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
2 studies on this page
Indexing hint: Clinical trial · 2016
Caron et al. 2016Pituitarycited by 32
PMID 26603536PMC4799252DOI 10.1007/s11102-015-0693-yPUB-26603536
Indexing hint: Clinical trial · 2014
Caron et al. 2014The Journal of clinical endocrinology and metabolismcited by 129
PMID 24423301PMC4009579DOI 10.1210/jc.2013-3318PUB-24423301
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