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Lanreotide as Primary Treatment for Acromegalic Patients With Pituitary Gland Macroadenoma (PRIMARYS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00690898
First received: June 3, 2008
Last updated: February 27, 2014
Last verified: February 2014

June 3, 2008
February 27, 2014
May 2008
February 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
The primary efficacy endpoint will be the percentage of patients achieving reduction in tumor volume at V5 (at Week 48) in comparison to baseline (as measured by MRI) [ Time Frame: From W1 (baseline) to W48. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00690898 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Prolactin Levels [ Time Frame: Week 12, 24 and 48 ] [ Designated as safety issue: No ]
  • Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Arthralgia) From Baseline [ Time Frame: Week 12, 24 and 48 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Acromegaly Quality of Life Assessment (AcroQoL) questionnaire response scores range from 0 to 100. Higher scores indicate best possible Quality of Life.
  • Change of serum IGF-1 level and serum GH levels [ Time Frame: At W1, 12, 24 & 48 ] [ Designated as safety issue: No ]
  • Changes of prolactin level in patients with initially increased prolactin level (at screening) [ Time Frame: At each assessment (W12, 24 & 48). ] [ Designated as safety issue: No ]
  • Change of clinical signs of acromegaly [ Time Frame: At each assessment visit at W12,24 &48 ] [ Designated as safety issue: No ]
  • Changes in the quality of life assessment [ Time Frame: At each assessment visit at W12, 24 & 48 ] [ Designated as safety issue: No ]
  • Adverse events and local tolerability information [ Time Frame: Recorded at any time during the study ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: Recorded at each assessment ] [ Designated as safety issue: Yes ]
  • Physical examination findings [ Time Frame: Recorded at each assessment ] [ Designated as safety issue: Yes ]
  • Gallbladder ultrasound [ Time Frame: Assessed at screening and W48 ] [ Designated as safety issue: Yes ]
  • Laboratory tests: standard haematology and biochemistry analyses [ Time Frame: At W1 and W48 ] [ Designated as safety issue: Yes ]
  • Glucose tolerance based on fasting blood glucose [ Time Frame: At W12, 24 & 48 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Lanreotide as Primary Treatment for Acromegalic Patients With Pituitary Gland Macroadenoma
Phase IIIb, Multicentre, Open-label, Single-arm, Study to Assess the Efficacy and Safety of Lanreotide Autogel 120 mg Administered Every 28 Days as Primary Medical Treatment in Acromegalic Patients With Macroadenoma

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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acromegaly
Drug: Lanreotide autogel 120 mg
12 months
Experimental: Lanreotide autogel 120 mg
Intervention: Drug: Lanreotide autogel 120 mg
Caron PJ, Bevan JS, Petersenn S, Flanagan D, Tabarin A, Prévost G, Maisonobe P, Clermont A; on behalf of the PRIMARYS Investigators. Tumor Shrinkage with Lanreotide Autogel 120 mg as Primary Therapy in Acromegaly: Results of a Prospective Multicenter Clinical Trial. J Clin Endocrinol Metab. 2013 Jan 1:jc20133318. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
108
February 2012
February 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Czech Republic,   Finland,   France,   Germany,   Italy,   Netherlands,   Turkey,   United Kingdom
 
NCT00690898
2-79-52030-207, 2007-000155-34
Yes
Ipsen
Ipsen
Not Provided
Study Director: Antoine Clermont, MD Ipsen
Ipsen
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP