Pilot Study to Determine Safety and Efficacy of Orbital Injections of LIPO-102 in Patients With Symptomatic Exophthalmos Associated With Thyroid-related Eye Disease (TED)

NCT ID: NCT00954057

Last Updated: 2015-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-06-30

Brief Summary

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This is a pilot study to determine the safety and efficacy of orbital injections of LIPO-102.

Detailed Description

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Conditions

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Thyroid-Related Eye Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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LIPO-102

Intraorbital Injection

Group Type EXPERIMENTAL

LIPO-102

Intervention Type DRUG

intraorbital injection

Placebo

Intraorbital Injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

intraorbital injection

Interventions

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LIPO-102

intraorbital injection

Intervention Type DRUG

Placebo

intraorbital injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or Non pregnant female
* Symptomatic exophthalmos
* Inactive Thyroid Eye Disease
* Signed informed consent

Exclusion Criteria

* Known hypersensitivity to study drugs
* Treatment with an investigational agent within 30 days of first dose
* History of Thyroid Eye Disease less than 6 months
* Previous decompression surgery
* Glaucoma
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Neothetics, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Adelaide, , Australia

Site Status

Brisbane, , Australia

Site Status

Melbourne, , Australia

Site Status

Sydney, , Australia

Site Status

Auckland, , New Zealand

Site Status

Countries

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Australia New Zealand

Other Identifiers

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LIPO-102-CL-06

Identifier Type: -

Identifier Source: org_study_id

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