Therapeutic Strategies in Acromegalic Subjects Treated With Lanreotide 120mg

NCT02698384 | Terminated

• 1 other identifier: A-54-52030-315
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 10

Brief Summary

The study aims to evaluate the biochemical and clinical effectiveness on symptoms and tumor size of a monotherapy with Lanreotide 120mg in acromegalic subjects, to describe criteria for starting alternative strategies, and to describe the modalities and the global effectiveness of alternative strategies.

Conditions

Acromegaly

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects who achieve a safe concentration of random Growth Hormone (GH) (≤2.5 ng/mL) and normal age and sex-matched Insulin-like Growth Factor-1 (IGF-1) concentration of the monotherapy phase.

  Month 5

Secondary Outcomes (15)

• Profile of subjects

  Baseline

• History of acromegaly

  Baseline

• History of treatment

  Baseline

• Achievement of safe concentration of random GH (≤2.5 ng/mL) and normal age- and sex-matched IGF-1 concentrations of the monotherapy phase

  Month 12 and 18

• Raw values at each visit and change from baseline in random Growth Hormone (GH)

  Baseline, month 5, 12 and 18

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Acromegalic subjects

You may qualify if:

• Male or female aged 18 years or more, suffering from acromegaly
• Treatment naïve or treated subject (whatever the previous treatments except Lanreotide 120mg and radiotherapy) who does not achieve biochemical control in the physician's opinion. Requiring a treatment with Somatostatin analog (SSA)
• Having performed a Magnetic Resonance Imaging (MRI) to evaluate the tumor size within the previous 12 weeks (post-surgery MRI for operated subjects)
• In whom the physician has already decided to initiate a treatment with Lanreotide 120mg as a monotherapy

You may not qualify if:

• Subject previously/currently treated with Lanreotide 120mg
• History of radiotherapy for acromegaly
• Subject who requires a surgical intervention for relief of any sign or symptom associated with tumor compression
• Concomitant prolactin hypersecretion requiring a treatment with dopaminergic agonists
• Active neoplastic disease

Sponsors & Collaborators

• Ipsen: lead

Study Sites (10)

Hoptial Nord

Amiens, 80054, France

Location

Hopital jean Minjoz

Besançon, 25030, France

Location

Hopital Neuro-Cardiologique, Fédération d'Endocrinologie

Bron, 69677, France

Location

Hopital Albert Michallon

La Tronche, 38700, France

Location

Hopital De La Conception

Marseille, 13005, France

Location

Hopital Haut Leveque

Pessac, 33604, France

Location

Hopital Robert Debre

Reims, 51092, France

Location

Hopital Nord

Saint-Etienne, 42055, France

Location

Hopital De Hautepierre

Strasbourg, 67098, France

Location

Hopital Larrey

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Acromegaly

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2016
• First Posted: March 3, 2016
• Study Start: January 1, 2016
• Primary Completion: January 1, 2016
• Study Completion: June 1, 2016
• Last Updated: December 21, 2018

Record last verified: 2018-12

Locations

FR (10)