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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00954057




Registration number
NCT00954057
Ethics application status
Date submitted
4/08/2009
Date registered
5/08/2009
Date last updated
5/03/2015

Titles & IDs
Public title
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)
Scientific title
A Single-masked, Placebo Controlled, Multi-center Pilot Study to Determine the Safety and Efficacy of Orbital Injections of a Fixed Dose of LIPO-102 in Patients With Symptomatic Exophthalmos Associated With Thyroid-related Eye Disease
Secondary ID [1] 0 0
LIPO-102-CL-06
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thyroid-Related Eye Disease 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LIPO-102
Treatment: Drugs - Placebo

Experimental: LIPO-102 - Intraorbital Injection

Placebo Comparator: Placebo - Intraorbital Injection


Treatment: Drugs: LIPO-102
intraorbital injection

Treatment: Drugs: Placebo
intraorbital injection

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety: physical examinations, laboratory tests, VISA activity score, AE assessments
Timepoint [1] 0 0
8 weeks treatment and 1 week follow up
Secondary outcome [1] 0 0
Efficacy: change in proptosis, VISA activity score, VAS for Eye Appearance Satisfaction
Timepoint [1] 0 0
8 weeks treatment and 1 week follow up

Eligibility
Key inclusion criteria
- Male or Non pregnant female

- Symptomatic exophthalmos

- Inactive Thyroid Eye Disease

- Signed informed consent
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Brisbane
Recruitment hospital [3] 0 0
- Melbourne
Recruitment hospital [4] 0 0
- Sydney
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Neothetics, Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a pilot study to determine the safety and efficacy of orbital injections of LIPO-102.
Trial website
https://clinicaltrials.gov/show/NCT00954057
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications