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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Lanreotide as Primary Treatment for Acromegalic Patients With Pituitary Gland Macroadenoma

Short name PRIMARYS

NCTNCT00690898 (opens ClinicalTrials.gov in a new tab)Other id2-79-52030-207Other id2007-000155-34

Overview

Status
Completed
Phase
Phase 3
Enrollment
108 participants (actual)
Sponsor
Ipsen · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
9 countries

Belgium, Czechia, Finland, France, Germany, Italy, Netherlands, Turkey (Türkiye), United Kingdom

Start
May 2008
Primary completion
Feb 2012
Completion
Feb 2012
First posted
5 Jun 2008 (estimated)
Last update posted
14 Oct 2022
Conditions
Acromegaly

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200820092010201120122013
  1. Ph 3

    PRIMARYS

    NCT00690898

    May 2008 to Feb 2012

Registry summary

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.

Interventions

  • Lanreotide autogel 120 mgDrug

Arms1

  • Experimental

    Lanreotide autogel 120 mg

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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

    Registry description

    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 outcomes(10)
  1. 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

  2. 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

  3. 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

  4. Change From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Prolactin Levels

    Time frame · Week 12, 24 and 48

  5. Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Arthralgia) From Baseline

    Time frame · Week 12, 24 and 48

    Registry description

    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.

  6. Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Excessive Perspiration) From Baseline

    Time frame · Week 12, 24 and 48

    Registry description

    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.

  7. Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Fatigue) From Baseline

    Time frame · Week 12, 24 and 48

    Registry description

    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.

  8. Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Headache) From Baseline

    Time frame · Week 12, 24 and 48

    Registry description

    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.

  9. Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Soft Tissue Swelling) From Baseline

    Time frame · Week 12, 24 and 48

    Registry description

    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.

  10. Changes in the Global Acromegaly Quality of Life Assessment (AcroQoL) From Baseline

    Time frame · Week 12, 24 and 48

    Registry description

    Acromegaly Quality of Life Assessment (AcroQoL) questionnaire response scores range from 0 to 100. Higher scores indicate best possible Quality of Life.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Week 1 and Week 48

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)

GroupValue (percentage of subjects)
Lanreotide Autogel 120 mg62.9
Secondary and other outcome results(7)
Secondary outcomeNumber· Baseline (week 1) to week 12 and week 24

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).

GroupValue (participants)
Lanreotide Autogel 120 mg46
Secondary outcomeMean· Week 12, 24, and 48

Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of IGF-1 Levels

GroupValue (percentage change)
Lanreotide Autogel 120 mg-43.8
Secondary outcomeMean· Week 12, 24, and 48

Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Serum GH Levels.

GroupValue (percentage change)
Lanreotide Autogel 120 mg-62.1
Secondary outcomeMean· Week 12, 24 and 48

Change From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Prolactin Levels

GroupValue (mcg/L)Spread
Lanreotide Autogel 120 mg48.024.4
Secondary outcomeNumber· Week 12, 24 and 48

Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Arthralgia) From Baseline

GroupValue (percentage of subjects)
Lanreotide Autogel 120 mg9.1
Secondary outcomeNumber· Week 12, 24 and 48

Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Excessive Perspiration) From Baseline

GroupValue (percentage of subjects)
Lanreotide Autogel 120 mg11.4
Secondary outcomeNumber· Week 12, 24 and 48

Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Fatigue) From Baseline

GroupValue (percentage of subjects)
Lanreotide Autogel 120 mg13.6

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther 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 / 9072 / 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

Studies2

Studies that cite this trial.

More studies

2 studies on this page

Indexing hint: Clinical trial · 2016

Effects of lanreotide Autogel primary therapy on symptoms and quality-of-life in acromegaly: data from the PRIMARYS study.

Caron et al. 2016Pituitarycited by 32

PMID 26603536PMC4799252DOI 10.1007/s11102-015-0693-yPUB-26603536

CC BY
Download PDF

Indexing hint: Clinical trial · 2014

Tumor shrinkage with lanreotide Autogel 120 mg as primary therapy in acromegaly: results of a prospective multicenter clinical trial.

Caron et al. 2014The Journal of clinical endocrinology and metabolismcited by 129

PMID 24423301PMC4009579DOI 10.1210/jc.2013-3318PUB-24423301

Free to read · publisher termsCC BY-NC
Read at source

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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