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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00954057
Ethics application status
Date submitted
4/08/2009
Date registered
6/08/2009
Date last updated
26/03/2015

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
Eye 0 0 0 0
Diseases / disorders of the eye
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders

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
Sex
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
1/09/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2011
Sample size
Target
Accrual to date
Final
11
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/study/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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00954057