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Completed

NCT Number: NCT00216398

Lanreotide Autogel in Patients With Acromegaly Previously Treated With Octreotide LAR

The purpose of this study is to assess the efficacy, safety and patient acceptability of Somatuline Autogel in patients with acromegaly previously treated with octreotide LAR.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of acromegaly
  • The patient must have been tested at Week -4 (4 weeks prior to the Baseline visit) and shown to have a GH level <10 mU/L.
  • The patient must have been treated with a stable dose of octreotide LAR for at least four months prior to study entry
  • Life expectancy of at least 2 years

Exclusion criteria

  • Adenectomy within past 6 months, or likely during study period
  • Radiotherapy for acromegalic disease within 1 year, or likely during study period
  • Unstable concomitant dopamine agonist therapy

Treatment and study plan

Lanreotide (Autogel formulation)

Drug

Primary outcomes

  1. The percentage of patients with GH control (<5.0 mU.L) and normalised IGF-1 at week 44 compared to the baseline (Week 0) visit.

Secondary outcomes

  1. The percentage of patients with GH control (< 5.0 mU/L) at each visit to week 44 compared to the baseline (Week 0) visit.

  2. The percentage of patients with normalised IGF-1 compared to the baseline visit.

  3. Change in the GH values compared to the baseline (Week 0) visit.

  4. Change in the IGF-1 values compared to the baseline (Week 0) visit.

  5. Change in serum lanreotide levels compared to the baseline (Week 0) visit.

  6. Change in the serum octreotide levels compared to the baseline visit.

  7. Patient evaluation of lanreotide Autogel treatment compared with evaluation of octreotide LAR treatment.

  8. Investigator evaluation of lanreotide Autogel treatment compared with evaluation of octreotide LAR treatment.

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

A Phase IV, Open-label, Single Group Study to Evaluate the Dosing, Efficacy and Safety of Lanreotide Autogel® in Patients With Acromegaly Previously Treated With Octreotide LAR

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Sep 22, 2005
Registry last updated
Aug 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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