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AcromegalyPhase 3NCT01295060

Long-term Safety and Efficacy Study of Octreotide Implant in Patients With Acromegaly

A Phase 3 study testing Octreotide in people with Acromegaly, run by Endo USA Inc., a Keenova Therapeutics Company at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a long term study to evaluate the safety, tolerability and efficacy of an Octreotide Implant in patients that were previously treated with an Octreotide implant. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acromegaly
What is being tested?
Octreotide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
6 sitesUnited States
Study dates
Feb 2011to Jun 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Currently enrolled in the Extension Phase of Study IP107-001 and received at least one 84-mg octreotide hydrogel implant prior to enrollment OR previously enrolled in the Extension Phase of Study IP107-001 and currently taking lanreotide or octreotide.
  • Subjects who have been successfully treated with the 84-mg octreotide hydrogel implant in Study IP107 001.
  • In the opinion of the Investigator; subject has no unstable chronic medical conditions and no clinically significant findings that would preclude subject's participation in the study.
  • Subjects must be able to communicate, provide and sign written informed consent, and be willing to participate and comply with study requirements.

Who cannot join

  • Pituitary surgery less than 3 months prior to enrollment into this study
  • Liver disease (eg, cirrhosis, chronic active or persistent hepatitis or persistent abnormalities of ALT, AST [level >2× normal] or direct bilirubin [level >1.5× normal])
  • Unstable angina, sustained ventricular arrhythmias or heart failure (NYHA III and IV)
  • Acute myocardial infarction within 3 months of Screening
  • Uncontrolled diabetes defined as having an HbA1c ≥9%
  • Symptomatic cholelithiasis
Show all 13Show fewer
  • History of drug or alcohol abuse
  • Received any investigational drug or participated in another clinical trial except for study IP107 001 within 30 days of enrollment into this study
  • Received radiotherapy for pituitary tumor or any radiotherapy above the neck at any time prior to enrollment into this study
  • Receiving pegvisomant, dopamine agonist or other therapy in combination with somatostatin to control GH or IGF-1 levels prior to enrollment into this study
  • History or presence of significant cardiovascular, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric disease, any other severe coexisting or, terminal systemic disease that limits life expectancy, or may interfere with the conduct of the study, or subjects who are incarcerated in penal institutions or are committed to mental institutions
  • Women who are pregnant or lactating. For females of childbearing potential, a positive pregnancy test prior to enrollment, or an unwillingness to use accepted forms of reliable birth control for study duration (including bilateral tubal ligation, use of oral contraceptives, double barrier methods [diaphragm with spermicidal gel or condoms with contraceptive foam], Depo-Provera®, hormonal implants, partner vasectomy, and total abstinence). Pregnancy tests are not required (indicate "n/a") for males, or for females not of childbearing potential (post-menopausal with last menstrual period >1 year ago or total hysterectomy with bilateral oophorectomy)
  • An unwillingness on the part of a male subject to abstain from sexual intercourse with pregnant or lactating women or an unwillingness to use a condom and spermicide and another form of contraception (eg, IUD, birth control pills taken by female partner, diaphragm with spermicide) if engaging in sexual intercourse with a woman who could become pregnant until discharge from the study

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Study site

    Baltimore, Maryland, 21215

  • Study site

    Chicago, Illinois, 60611

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Denver, Colorado, 80220

  • Study site

    Portland, Oregon, 97239

  • Study site

    Seattle, Washington, 98122

Other trials in United States

About this study

Official title: PHASE IIIB, OPEN-LABEL, MULTICENTER STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF AN 84-MG OCTREOTIDE SUBCUTANEOUS HYDROGEL IMPLANT IN SUBJECTS WITH ACROMEGALY

This is a long term study to evaluate the safety, tolerability and efficacy of an Octreotide Implant in patients that were previously treated with an Octreotide implant.

Read the detailed description

Evaluation on the long-term safety and tolerability, including local tolerability of the implant site, of the 84-mg octreotide hydrogel implant in subjects with acromegaly who had been successfully treated with the 84-mg octreotide hydrogel implant in the Phase III study IP107-001.

Conditions
Acromegaly
Being tested
Octreotide
Keywords
Acromegaly, Octreotide, IGF-1, Growth Hormone, Implant, Hydrogel
Medical subject headings
Acromegaly

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OctreotideDrug

    84 mg Octreotide Implant

Study groups in NCT01295060
Study groupRoleWhat they receive
Octreotide ImplantExperimentalNot described
Receives: Drug: Octreotide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Long term safety and tolerability of the Octreotide Implant

    Subjects will be assessed every 3 months via adverse event reporting and examination of the implantation site

    Measured: every 3 months for up to 2 years

Secondary outcomes (1)

  1. Evaluate the long term efficacy of the Octreotide Implant

    Patients will have GH and IGF-1 analyzed every 3 months

    Measured: every 3 months for up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completionApr 2012
  4. Study completionJun 2012

Why it stopped: Program was terminated for business reasons

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01295060
Sponsor's protocol ID
EN3332-301
Status last verified
Sep 2013
First submitted
10 Feb 2011
Last updated
20 Sep 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Octreotide in people with Acromegaly, run by Endo USA Inc., a Keenova Therapeutics Company at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Program was terminated for business reasons). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Long term safety and tolerability of the Octreotide Implant (time frame: every 3 months for up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01295060.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2013.

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