Completed studies and results - University of the Sunshine Coast, Queensland, Australia

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Completed studies and results

Helping to 'close the loop'.

When available, the results of studies completed by USC Clinical Trials are listed below.

Respiratory
Protocol Number Protocol Results Available?
205715 A Phase III, randomized, double-blind, active controlled, parallel group study, comparing the efficacy, safety and tolerability of the fixed dose combination FF/UMEC/VI with the fixed dose dual combination of FF/VI, administered once-daily via a dry powder inhaler in subjects with inadequately controlled asthma

Media Release

Results Available

200812 A Phase III, 4-week, randomised, double-blind study to compare ‘closed’ triple therapy (FF/UMEC/VI), 'open' triple therapy (FF/VI + UMEC) and dual therapy (FF/VI) in subjects with chronic obstructive pulmonary disease (COPD) Results Available
RTB-101-204 A Multicenter, Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Determine if RTB101 Prevents Symptomatic Respiratory Illness Associated with Laboratory-Confirmed Pathogens in the Elderly Results Pending
FBP-001 A phase I/II study of povidone-iodine nasal spray (“Nasodine”) to investigate safety and tolerability in healthy volunteers (Stage 1), and to investigate safety and efficacy in patients with the common cold (Stage 2). Results Pending
FBP-002 A phase III study of the safety and efficacy of povidone-iodine nasal spray (“Nasodine”) in the treatment of subjects with the common cold in the natural setting. Results Pending
Devices
Protocol Number Protocol Results Available?
FLU-AUS-1701 A Prospective Multi-Centre Study of the ellume·lab Flu A+B Test and iTreat Flu A+B Flu Test Performance versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction. Results Pending
RESP16001 A PROSPECTIVE MULTI-CENTRE STUDY OF THE RESPIRIO FLU TEST AND eLab FLU TEST PERFORMANCE VERSUS REVERSE TRANSCRIPTASE POLYMERASE CHAIN REACTION (RT-PCR) FOR THE RAPID DETECTION OF INFLUENZA A/B. Results Pending
GAS-AUS-1701 A PROSPECTIVE MULTI-CENTRE STUDY OF THE PERFORMANCE OF THE ELLUME·LAB GROUP A STREP TEST VERSUS CULTURE FOR THE RAPID DETECTION OF GROUP A STREPTOCOCCUS IN PARTICIPANTS WITH ACUTE PHARYNGITIS Results Pending
Inflammatory Bowel Diseases
Protocol Number Protocol Results Available?
RPC01-3202 INDUCTION STUDY #2 - A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ORAL OZANIMOD AS INDUCTION THERAPY FOR MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE Study Ongoing
GS-US-419-3895 Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease Results Pending
GS-US-419-3896 A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease Study Ongoing
GA29144 A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE Study Ongoing
GA29145 AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144 Study Ongoing
GS-US-418-3898 Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis Results Pending
GS-US-418-3899 A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis Study Ongoing
Opthalmology
Protocol Number Protocol Results Available?
SHP640-301 A Phase 3, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of SHP640 (PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension Compared to PVP-Iodine and Placebo in the Treatment of Adenoviral Conjunctivitis Results Pending
SHP640-303 A Phase 3, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of SHP640 (PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension Compared to Placebo in the Treatment of Bacterial Conjunctivitis Results Available
P2-868963_001 A Multicenter, Prospective, Randomized, Double- Masked, Phase 2 Study Evaluating the Safety, Tolerability, and Efficacy of Topical AG-86893 in Patients with Pterygium

Preliminary Media Release

Results Pending

Heart and Cardiovascular
Protocol Number Protocol Results Available?
1002-043 A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFECTS OF BEMPEDOIC ACID (ETC-1002) ON THE OCCURRENCE OF MAJOR CARDIOVASCULAR EVENTS IN PATIENTS WITH, OR AT HIGH RISK FOR, CARDIOVASCULAR DISEASE WHO ARE STATIN INTOLERANT

Preliminary Media Release

Results Pending

1245-0167 A phase III randomised, double-blind trial to evaluate the effect of 12 weeks treatment of once daily EMPagliflozin 10 mg compared with placebo on ExeRcise ability and heart failure symptoms, In patients with chronic HeArt FaiLure with preserved Ejection Fraction (HFpEF) (EMPERIAL – preserved) Results Pending
1245-0168 A phase III randomised, double-blind trial to evaluate the effect of 12 weeks treatment of once daily EMPagliflozin 10 mg compared with placebo on ExeRcise ability and heart failure symptoms, In patients with chronic HeArt FaiLure with reduced Ejection Fraction (HFrEF) (EMPERIAL – reduced)

Preliminary Media Release

Results Pending

ARROAPOC31001 A Phase 1 Single and Multiple Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of ARO-APOC3 in Adult Healthy Volunteers as well as in Severely Hypertriglyceridemic Patients and Patients with Familial Chylomicronemia Syndrome Recruiting
Haematology
Protocol Number Protocol Results Available?
BIVV009-03 A PHASE 3 PIVOTAL, OPEN-LABEL,MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WHO HAVE A RECENT HISTORY OF BLOOD TRANSFUSION Results Pending
BIVV009-04 A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WITHOUT A RECENT HISTORY OF BLOOD TRANSFUSION Recruiting
Vaccines
Protocol Number Protocol Results Available?
V160-002 Double-Blind, Randomized, Placebo-Controlled Phase 2b, Multi-center Study to Evaluate the Safety, Tolerability, Efficacy and Immunogenicity of a 2-Dose and a 3- Dose Regimen of V160 (Cytomegalovirus [CMV] Vaccine) in Healthy Seronegative Women, 16 to 35 Years of Age Results Pending
FLU009 A Phase 2b Study to Determine the Efficacy of Candidate Influenza Vaccine MVA-NP+M1 in Adults aged 18 years and over

Preliminary Media Release

Results Pending

P2-868963_001 A Multicenter, Prospective, Randomized, Double- Masked, Phase 2 Study Evaluating the Safety, Tolerability, and Efficacy of Topical AG-86893 in Patients with Pterygium

Preliminary Media Release

Results Pending

V199_04 A Phase IIIb-IV, Multicentre, Randomised, Open-label Study to Characterise the Reactogenicity of Afluria Quad Junior in Children 6 Months to Less Than 3 Years, and Afluria Quad in Children 3 Years to Less Than 9 Years Across Three Influenza Seasons

Recruiting

Cosmetics
Protocol Number Protocol Results Available?
MT14-AU18GBL208 Phase II, Randomized, Double-Blind, Placebo Controlled, Multi-Center, Dose-ranging and Open Label Extension Clinical Trial to Evaluate the Efficacy and Safety of MBA-P01 in Treatment of Moderate to Severe Glabellar Lines Study Ongoing
MT14-AU18LCL209 Phase , Randomized, Double-Blind, Placebo Controlled, Multi-Center, Dose-ranging and Open Label Extension Clinical Trial to Evaluate the Efficacy and Safety of MBA-P01 in Treatment of Moderate to Severe Lateral Canthal Lines Study Ongoing
Arthritis
Protocol Number Protocol Results Available?
ZYN2-CL-005 A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Multiple Center, Multiple-Dose Study to Assess the Efficacy and Safety of ZYN002 Administered as a Transdermal Gel to Patients with Knee Pain due to Osteoarthritis Results Pending
Sub-001 A Randomised, Double-blind, Placebo Controlled Study to Investigate the Efficacy on Pain Reduction and Safety of Swisse High Strength Deep Sea Krill Oil (Superba BOOST) in Adults with Mild to Moderate Osteoarthritis of the Knee Results Pending
Epilepsy
Protocol Number Protocol Results Available?
ZYN2-CL-03 A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Multi-Centre, Multiple-Dose Study to Assess the Safety and Efficacy of ZYN002 Administered as a Transdermal Gel to Patients with Partial Onset Seizures, Synthetic Transdermal Cannabidiol for the Treatment of Epilepsy (STAR 1) Results Pending
ZYN2-CL-004 Open Label Extension Study to ZYN2-CL-03 to Assess the Long Term Safety and Efficacy of ZYN002 Administered as a Transdermal Gel to Patients with Partial Onset Seizures (STAR 2) Results Pending
Dietary and Metabolic Intolerances
Protocol Number Protocol Results Available?
Nexvax2-1005 A BIOEQUIVALENCE STUDY OF NEXVAX2 IN HLA-DQ2.5+ ADULTS WITH CELIAC DISEASE

Media Release

Results Pending

Nexvax2-2006 A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY IN HLA-DQ2.5+ ADULTS WITH CELIAC DISEASE TO ASSESS THE EFFECT OF NEXVAX2 ON SYMPTOMS AFTER MASKED GLUTEN FOOD CHALLENGE

Study Closure Notification

Results Pending

CDX6114-002 A Phase 1, Multi-center, Randomized, Double-blind, Placebo-controlled, Cross-over Study to Evaluate the Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of a Single Oral Dose of CDX-6114 in Patients with Phenylketonuria (PKU).

Recruiting