Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001093875
Ethics application status
Approved
Date submitted
8/10/2012
Date registered
12/10/2012
Date last updated
12/10/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Double-Blind Study to Evaluate the Safety and Efficacy of RT001 Gel and Placebo for Treatment of Allergic Rhinitis
Scientific title
A Phase 2, Double-Blind, Placebo-Controlled, Parallel Dose Study to Evaluate the safety and Efficacy of RT001 Gel for the Treatment of Allergic Rhinitis
Secondary ID [1] 281329 0
Nil
Universal Trial Number (UTN)
U1111-1135-3434
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allergic rhinitis 287547 0
Condition category
Condition code
Inflammatory and Immune System 287872 287872 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Single 5 ng dose of RT001 Topical Gel applied to the nasal cavity. The dose is applied only once
Arm2: Single dose of Placebo Topical Gel applied to the nasal cavity. The dose is applied only once
Intervention code [1] 285791 0
Treatment: Drugs
Comparator / control treatment
Placebo Topical Gel
Control group
Placebo

Outcomes
Primary outcome [1] 288091 0
Change from baseline in Total Nasal Symptom score for RT001 versus placebo. The Total Nasal Symptom Score is the sum of 4 individual participant-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each rated on a 4-point scale of none to severe.
Timepoint [1] 288091 0
Baseline, Week 4
Secondary outcome [1] 299415 0
Individual nasal symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, are each rated by the subject on a 4-point scale of none to severe.
Timepoint [1] 299415 0
Baseline, Week 2, Week 4, Week 8
Secondary outcome [2] 299416 0
Rhinoconjuntivitis Quality of Life Questionnaire (RQLQ)
Timepoint [2] 299416 0
Baseline, Week 2, Week 4, Week 8
Secondary outcome [3] 299417 0
Peak Nasal Inspiratory Flow (PNIF) and Peak Expiratory Flow (PEF) as measured by flow meters
Timepoint [3] 299417 0
Baseline, Week 2, Week 4, Week 8
Secondary outcome [4] 299430 0
Safety assessments include safety labs, local irritation at gel application site, cranial nerve evaluations, adverse events and concomitant medication use.
Timepoint [4] 299430 0
Baseline and follow-up visits at Day 2, Week 2, Week 4 and Week 8

Eligibility
Key inclusion criteria
Seasonal allergic rhinitis reactive to rye grass allergen on skin prick test
Total nasal symptom score of at least 7 (scale 0-12)
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nasal disease such as sinusitis, polyps, or nasal structural abnormalities likely to affect application of medication
Bacterial or viral infection within 14 days of screening
Nasal surgery within 1 year
Active asthma requiring medication more than 3 times per week or significant pulmonary disease within 1 year
Frequent use of high doses of anti-inflammatory drugs within 2 weeks of treatment or antibiotics within 4 weeks
Current use of aminoglycoside or other agents that might interfere with neuromuscular transmission
Previous treatment with botulinum toxin or history of botulism
Neurological condition that might place subject at increased risk with exposure to Botulinum Toxin Type A

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)
Qualified subjects will be enrolled and allocated to treatment according to a sequential randomization held by the unblinded dose preparer and kept in a secure place, unavailable to staff involved in subject treatment and assessment. Active and placebo treatments appear identical.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization sequence will be prepared by an unblinded study statistician using a permuted block randomization. Active or placebo treatment will be assigned to a subject randomization number. These numbers will be assigned sequentially to subjects as they qualify for inclusion in the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/10/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286090 0
Commercial sector/Industry
Name [1] 286090 0
Revance Therapeutics, Inc.
Country [1] 286090 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
INC Research Australia Pty Ltd
Address
124 Lipson St
Port Adelaide, SA 5015
Country
Australia
Secondary sponsor category [1] 284904 0
None
Name [1] 284904 0
Address [1] 284904 0
Country [1] 284904 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288145 0
Research Directorate, Southern Health, Monash Medical Centre
Ethics committee address [1] 288145 0
Ethics committee country [1] 288145 0
Australia
Date submitted for ethics approval [1] 288145 0
09/08/2012
Approval date [1] 288145 0
28/09/2012
Ethics approval number [1] 288145 0
12233A

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34780 0
Address 34780 0
Country 34780 0
Phone 34780 0
Fax 34780 0
Email 34780 0
Contact person for public queries
Name 18027 0
Sharon Hall
Address 18027 0
7555 Gateway Boulevard
Newark, CA 94560
Country 18027 0
United States of America
Phone 18027 0
+1 510-742-3409
Fax 18027 0
+1 510-662-4925
Email 18027 0
[email protected]
Contact person for scientific queries
Name 8955 0
Sharon Hall
Address 8955 0
7555 Gateway Boulevard
Newark, CA 94560
Country 8955 0
United States of America
Phone 8955 0
+1 510-742-3409
Fax 8955 0
+1 510 662 4925
Email 8955 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.