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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:
Information provided by (Responsible Party):
Lithera, Inc
ClinicalTrials.gov Identifier:
NCT00954057
First received: August 4, 2009
Last updated: June 3, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention Phase
Thyroid-Related Eye Disease
Drug: LIPO-102
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Lithera, Inc:

Primary Outcome Measures:
  • Safety: physical examinations, laboratory tests, VISA activity score, AE assessments [ Time Frame: 8 weeks treatment and 1 week follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy: change in proptosis, VISA activity score, VAS for Eye Appearance Satisfaction [ Time Frame: 8 weeks treatment and 1 week follow up ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: September 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LIPO-102
Intraorbital Injection
Drug: LIPO-102
intraorbital injection
Placebo Comparator: Placebo
Intraorbital Injection
Drug: Placebo
intraorbital injection

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00954057

Locations
Australia
Adelaide, Australia
Brisbane, Australia
Melbourne, Australia
Sydney, Australia
New Zealand
Auckland, New Zealand
Sponsors and Collaborators
Lithera, Inc
  More Information

No publications provided

Responsible Party: Lithera, Inc
ClinicalTrials.gov Identifier: NCT00954057     History of Changes
Other Study ID Numbers: LIPO-102-CL-06
Study First Received: August 4, 2009
Last Updated: June 3, 2013
Health Authority: United States: Food and Drug Administration
Australia: Therapeutic Goods Administration
New Zealand: Ministry of Health

Keywords provided by Lithera, Inc:
TED

Additional relevant MeSH terms:
Exophthalmos
Eye Diseases
Thyroid Diseases
Endocrine System Diseases
Orbital Diseases

ClinicalTrials.gov processed this record on November 20, 2014