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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00954057
First Posted: August 6, 2009
Last Update Posted: March 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Neothetics, Inc
August 4, 2009
August 6, 2009
March 26, 2015
September 2009
June 2011   (Final data collection date for primary outcome measure)
Safety: physical examinations, laboratory tests, VISA activity score, AE assessments [ Time Frame: 8 weeks treatment and 1 week follow up ]
Same as current
Complete list of historical versions of study NCT00954057 on ClinicalTrials.gov Archive Site
Efficacy: change in proptosis, VISA activity score, VAS for Eye Appearance Satisfaction [ Time Frame: 8 weeks treatment and 1 week follow up ]
Same as current
Not Provided
Not Provided
 
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)
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
This is a pilot study to determine the safety and efficacy of orbital injections of LIPO-102.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Thyroid-Related Eye Disease
  • Drug: LIPO-102
    intraorbital injection
  • Drug: Placebo
    intraorbital injection
  • Experimental: LIPO-102
    Intraorbital Injection
    Intervention: Drug: LIPO-102
  • Placebo Comparator: Placebo
    Intraorbital Injection
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
June 2011
June 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   New Zealand
 
 
NCT00954057
LIPO-102-CL-06
No
Not Provided
Not Provided
Neothetics, Inc
Neothetics, Inc
Not Provided
Not Provided
Neothetics, Inc
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP