NCT00499993

Brief Summary

The purpose of the protocol, is to evaluate if lanreotide Autogel 120 mg is effective in the control of Growth Hormone (GH) secretion in patients with active acromegaly.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2001

Geographic Reach
1 country

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 12, 2007

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

First QC Date

July 11, 2007

Last Update Submit

January 11, 2019

Conditions

Acromegaly

Outcome Measures

Primary Outcomes (1)

  • Growth hormone assessment

    At every visit

Secondary Outcomes (9)

  • Insulin-like Growth Factor 1 (IGF-1) and Acid-Labile Subunit (ALS) assessments

    At every visit (with the exception of ALS at study inclusion)

  • Prolactin (PRL) assessment

    At study inclusion, visit 1 and at the final visit of the study

  • Lanreotide assessment

    At every visit

  • Clinical symptoms

    At every visit

  • Quality of life

    At visit 1 and at the final visit of the study

  • +4 more secondary outcomes

Interventions

lanreotide (Autogel formulation), duration of treatment 46-48 weeksDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Documented diagnosis of active acromegaly, defined by serum GH levels above 5 µg/L, absence of reduction of serum GH levels below 1µg/L after oral glucose tolerance test (OGTT) and abnormal IGF-1 values

You may not qualify if:

  • Patients who have undergone pituitary surgery less than 3 months before selection
  • Patients previously treated with radiotherapy
  • Patients previously treated with somatostatin analogue except for a pre-surgical treatment not longer than 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Ospedali Riuniti di Bergamo

Bergamo, 24128, Italy

Location

Ospedale Maggiore

Bologna, 40133, Italy

Location

Clinica Medica - Sezione II Medicina Endocrinologia

Brescia, 25125, Italy

Location

Università deglis Studi di Cagliari

Cagliari, 09124, Italy

Location

Ospedale Garibaldi

Catania, 95123, Italy

Location

Università degli Studi di Ferrara

Ferrara, 44100, Italy

Location

Università degli Studi di Firenze

Florence, 50134, Italy

Location

D.i.S.E.M. Dipartimento di Scienze Endocrinologiche e Metaboliche

Genova, 16100, Italy

Location

Istituto Auxologico

Milan, 20100, Italy

Location

Ospedale Maggiore IRCCS

Milan, 20122, Italy

Location

Ospedale di Niguarda Cà Granda

Milan, 20162, Italy

Location

Università "Federico II" di Napoli

Napoli, 80131, Italy

Location

Ospedale "S. Luigi Gonzaga"

Orbassano (TO), 10043, Italy

Location

Università degli Studi di Padova

Padua, 35128, Italy

Location

Azienda Ospedaliera "V. Cervello"

Palermo, 90148, Italy

Location

Ospedale Cisanello

Pisa, 56100, Italy

Location

Servizio di Endocrinologia

Reggio Emilia, 42100, Italy

Location

Università "La Sapienza" di Roma

Roma, 00161, Italy

Location

Policlinico Agostino Gemelli

Roma, 00168, Italy

Location

Istituto di Patologia Speciale Medica e Metodologia Clinica

Sassari, 07199, Italy

Location

Università degli Studi di Ancona, Ospedale Umberto I

Sede Di Torrette (AN) Ancona, 60020, Italy

Location

Ospedale Molinette

Torino, 10126, Italy

Location

Ospedale Cà Foncello

Treviso, 31100, Italy

Location

Ospedale Santa Maria della Misericordia

Udine, 33100, Italy

Location

Related Publications (1)

  • Lombardi G, Minuto F, Tamburrano G, Ambrosio MR, Arnaldi G, Arosio M, Chiarini V, Cozzi R, Grottoli S, Mantero F, Bogazzi F, Terzolo M, Tita P, Boscani PF, Colao A. Efficacy of the new long-acting formulation of lanreotide (lanreotide Autogel) in somatostatin analogue-naive patients with acromegaly. J Endocrinol Invest. 2009 Mar;32(3):202-9. doi: 10.1007/BF03346453.

    PMID: 19542735RESULT

MeSH Terms

Conditions

Acromegaly

Interventions

lanreotideDuration of Therapy

Condition Hierarchy (Ancestors)

Bone Diseases, EndocrineBone DiseasesMusculoskeletal DiseasesHyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Ipsen Medical Director

    Ipsen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2007

First Posted

July 12, 2007

Study Start

January 1, 2001

Study Completion

May 1, 2003

Last Updated

January 15, 2019

Record last verified: 2019-01

Locations

IT(24)