Observational study comparing the safety and tolerability of Somatuline (Registered trade mark) Autogel (Registered trade mark) injected by Health Care Professionals and patients who inject at home for the treatment of acromegaly.

An observational, multicentre, open label non interventional programme to assess the long-term safety and efficacy of Somatuline (registered trade mark) Autogel (registered trade mark) in the treatment of acromegaly when administered by patients or their partners ("Home Injection Group") or administered by healthcare professionals.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12608000606381

Enrollment

Registered

2008-12-04

Start date

2009-04-14

Completion date

2011-05-30

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will compare the safety and tolerability of a treatment for acromegaly in two groups: one group is injected by a health care professional the other group will inject themselves or have a carer/partner inject.

Interventions

Somatuline Autogel for acromegaly. This will be administered subcutaneously at a dose and frequency clinically indicated. The dose and frequency for Somatuline Autogel will vary for participants depending on the physicians discretion. The duration of the observation will be up to 4 years. Both the health care professional group and home injection group will be exposed to the therapy. The home injection group will inject themselves or have a partner/carer inject.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients on a stable dose of Somatuline Autogel for at least 4 months and with a diagnosis of Acromegaly.

Exclusion criteria

Patients who are pregnant or breastfeeding.

Outcome results