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Trial · Interventional

CompletedPhase 4Registry data

Somatuline Autogel: Acromegaly Self/Partner Injection Study

NCTNCT00149188 (opens ClinicalTrials.gov in a new tab)Other idY-97-52030-150
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
30 participants (actual)
Sponsor
Ipsen · Industry
Design
Not randomized · Open label (no masking)
Countries
1 country

United Kingdom

Start
Feb 2004
Primary completion
24 Aug 2005
Completion
24 Aug 2005
First posted
8 Sept 2005 (estimated)
Last update posted
5 Aug 2019
Conditions
Acromegaly

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200420052006
  1. Ph 4

    Somatuline Autogel: Acromegaly Self/Partner Injection Study

    NCT00149188

    Feb 2004 to 24 Aug 2005

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Lanreotide (Autogel formulation)Drug

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

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

Secondary outcomes(3)

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

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

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2008

6 results

Home administration of lanreotide Autogel by patients with acromegaly, or their partners, is safe and effective.

Bevan et al. 2008Clinical endocrinologycited by 38

PMID 17892497PMC2268964DOI 10.1111/j.1365-2265.2007.03044.xPUB-17892497

CC BY6 results
Download PDFSee results (6)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 Exclusion Criteria: * 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

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