NCT00149188

Brief Summary

The purpose of this study is to allow patients with acromegaly, or their partners, to learn how to successfully inject Somatuline Autogel at home. Ability to perform unsupervised injections whilst maintaining adequate disease control will be assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2004

Geographic Reach
1 country

10 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

February 1, 2004

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2005

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
Last Updated

August 5, 2019

Status Verified

August 1, 2019

Enrollment Period

1.6 years

First QC Date

September 7, 2005

Last Update Submit

August 1, 2019

Conditions

Acromegaly

Keywords

Growth Hormone

Outcome Measures

Primary Outcomes (1)

  • To assess the ability of patients or their partners to perform unsupervised Somatuline Autogel injections.

Secondary Outcomes (3)

  • To assess whether administration of unsupervised injections of Somatuline Autogel has any effect on GH and IGF-1 control or serum lanreotide levels.

  • To assess patient/partner and healthcare professional experience with unsupervised injections.

  • To assess the safety of patients or their partners performance of unsupervised Somatuline Autogel injections.

Interventions

Lanreotide (Autogel formulation)DRUG

Eligibility Criteria

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

You may qualify if:

  • The patient must have a clinical diagnosis of acromegaly
  • The patient must have been tested and shown to have a GH level less than or equal to 10 micrograms/L within 28 days prior to the baseline visit
  • The patient must be currently treated with Somatuline Autogel and have been stable on their current dose for at least 6 months immediately prior to screening
  • The patient must be able to store study medication in a refrigerator in their own home

You may not qualify if:

  • The patient has had pituitary surgery (adenomectomy) within 6 months prior to screening
  • The patient has received pituitary radiotherapy within one year prior to screening
  • The patient is likely to require pituitary surgery (adenomectomy) or to receive radiotherapy during the study period
  • The patient is currently receiving a GH antagonist or a somatostatin analogue other than Somatuline Autogel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Michael White Centre Diabetes & Endocrinology, Hull Royal Infirmary

Hull, East Yorkshire, HU3 2JZ, United Kingdom

Location

Department of Endocrinology, The Royal Free Hospital

Hampstead, London, NW3 2QG, United Kingdom

Location

Dept of Endocrinology, Aberdeen Royal Infirmary

Aberdeen, AB25 2ZN, United Kingdom

Location

Department of Medicine, Queen Elizabeth Hospital

Birmingham, B15 2TH, United Kingdom

Location

Department of Endocrinology, Coventry & Warwickshire Hospital

Coventry, CV1 4FH, United Kingdom

Location

Department of Endocrinology, Leicester Royal Infirmary

Leicester, LE1 5WW, United Kingdom

Location

Department of Endocrinology, Manchester Royal Infirmary

Manchester, M13 9WL, United Kingdom

Location

The Oxford Centre for Diabetes, Endocrinology and Metabolism, The Churcill Hospital

Oxford, OX3 7LJ, United Kingdom

Location

Department of Endocrinology, Royal Hallamshire Hospital

Sheffield, S10 2JF, United Kingdom

Location

Department of Endocrinology, Sunderland Royal Hospital

Sunderland, SR4 7TP, United Kingdom

Location

Related Publications (1)

  • Bevan JS, Newell-Price J, Wass JA, Atkin SL, Bouloux PM, Chapman J, Davis JR, Howlett TA, Randeva HS, Stewart PM, Viswanath A. Home administration of lanreotide Autogel by patients with acromegaly, or their partners, is safe and effective. Clin Endocrinol (Oxf). 2008 Mar;68(3):343-9. doi: 10.1111/j.1365-2265.2007.03044.x. Epub 2007 Sep 24.

    PMID: 17892497RESULT

MeSH Terms

Conditions

Acromegaly

Interventions

lanreotide

Condition Hierarchy (Ancestors)

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

Study Officials

  • UK Medical Director, MD

    Ipsen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 8, 2005

Study Start

February 1, 2004

Primary Completion

August 24, 2005

Study Completion

August 24, 2005

Last Updated

August 5, 2019

Record last verified: 2019-08

Locations

GB(10)