Seasonal Allergic RhinitisPhase 2NCT01651871
Combination Study Of S-555739/Cetirizine HCl In Adult Patients With Seasonal Allergic Rhinitis
A Phase 2 study testing S-555739 Dose 1, S-555739 Dose 2 and Cetirizine HCl Dose 1 in people with Seasonal Allergic Rhinitis, run by Shionogi.
Trial summary
The primary objective of the study was to examine the efficacy and safety of S-555739/cetirizine HCl compared with the individual components and placebo. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- S-555739 Dose 1, S-555739 Dose 2 and Cetirizine HCl Dose 1
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 779 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to May 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- History and diagnosis of seasonal allergic rhinitis by skin prick test
- Have nasal symptom scores as defined by the study protocol
- Able to comply with study procedures
Who cannot join
- Any nasal disease or abnormality, active respiratory tract infections within the past 2 weeks, or recent nasal surgery or sinus surgery at Screening
- Use of any prohibited concomitant drugs or therapies
About this study
Official title: A Phase 2, Multicenter, Parallel-Group, Randomized, Double-Blind, Placebo- And Active Comparator-Controlled, Combination Study Of S-555739 And Cetirizine HCl In Adult Patients With Seasonal Allergic Rhinitis
The primary objective of the study was to examine the efficacy and safety of S-555739/cetirizine HCl compared with the individual components and placebo.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- S-555739 Dose 1, S-555739 Dose 2, Cetirizine HCl Dose 1, S-555739 placebo, Cetirizine HCl placebo
- Keywords
- Agents, anti allergic, Nasal congestion, Sneezing, Nasal discharge, D prostanoid (DP) receptor antagonist
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Nasal Obstruction, Sneezing, Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-555739 Dose 1Drug
S-555739 Dose 2Drug
Cetirizine HCl Dose 1Drug
S-555739 placeboDrug
Cetirizine HCl placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group 1 | Experimental | Not described Receives: Drug: S-555739 Dose 1; Drug: Cetirizine HCl Dose 1 |
| Treatment Group 2 | Experimental | Not described Receives: Drug: S-555739 Dose 2; Drug: Cetirizine HCl Dose 1; Drug: S-555739 placebo |
| Treatment Group 3 | Experimental | Not described Receives: Drug: S-555739 Dose 1; Drug: Cetirizine HCl placebo |
| Treatment Group 4 | Active comparator | Not described Receives: Drug: Cetirizine HCl Dose 1; Drug: S-555739 placebo |
| Treatment Group 5 | Placebo comparator | Not described Receives: Drug: S-555739 placebo; Drug: Cetirizine HCl placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in average morning/evening (AM/PM) reflective Total Nasal Symptom Score (rTNSS)
Measured: Change from baseline through the 2-week treatment period (Day 2 through Day 15)
Incidence of adverse events (AEs)
Measured: From Screening period to Week 6 (Follow-up)
Secondary outcomes (6)
Change in average AM/PM instantaneous Total Nasal Symptom Score (iTNSS)
Measured: Change from baseline through the 2-week treatment period (Day 2 through Day 15)
Change in average AM/PM Total Ocular Symptom Score
Measured: Change from baseline through the 2-week treatment period (Day 2 through Day 15)
Assessment of Quality of Life
Measured: Change from Week 3 to Week 5
Assessment of vital signs
Measured: At Week 1 (Screening), Week 2, Week 3, Week 4, and Week 5
Assessment of clinical laboratory parameters
Measured: At Week 1 (Screening), Week 4, Week 5, and Week 6 (Follow-up)
Assessment of electrocardiogram (ECG) findings
Measured: At Week 1 (Screening) and Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionNov 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by ShionogiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 779 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shionogi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shionogi Clinical Trials Administrator Clinical Support Help Line, Study director, Shionogi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651871
- Sponsor's protocol ID
- 1210D1526
- Status last verified
- Apr 2018
- First submitted
- 17 Jul 2012
- Last updated
- 27 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Parallel-Group, Randomized, Double-Blind, Placebo- And Active Comparator-Controlled, Combination Study Of S-555739 And Cetirizine HCl In Adult Patients With Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT01651871
- Acronym / sponsor ID
- 1210D1526
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- Agents, anti allergic, Nasal congestion, Sneezing, Nasal discharge, D prostanoid (DP) receptor antagonist
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 779 participants (actual)
- Lead sponsor
- ShionogiIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 27 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study was to examine the efficacy and safety of S-555739/cetirizine HCl compared with the individual components and placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Treatment Group 1 | Experimental | Drug: S-555739 Dose 1, Drug: Cetirizine HCl Dose 1 |
| Treatment Group 2 | Experimental | Drug: S-555739 Dose 2, Drug: Cetirizine HCl Dose 1, Drug: S-555739 placebo |
| Treatment Group 3 | Experimental | Drug: S-555739 Dose 1, Drug: Cetirizine HCl placebo |
| Treatment Group 4 | Active comparator | Drug: Cetirizine HCl Dose 1, Drug: S-555739 placebo |
| Treatment Group 5 | Placebo comparator | Drug: S-555739 placebo, Drug: Cetirizine HCl placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- History and diagnosis of seasonal allergic rhinitis by skin prick test
- Have nasal symptom scores as defined by the study protocol
- Able to comply with study procedures
Key exclusion criteria (2 listed)
- Any nasal disease or abnormality, active respiratory tract infections within the past 2 weeks, or recent nasal surgery or sinus surgery at Screening
- Use of any prohibited concomitant drugs or therapies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S-555739 Dose 1 | Drug | Treatment Group 1, Treatment Group 3 |
| S-555739 Dose 2 | Drug | Treatment Group 2 |
| Cetirizine HCl Dose 1 | Drug | Treatment Group 1, Treatment Group 2, Treatment Group 4 |
| S-555739 placebo | Drug | Treatment Group 2, Treatment Group 4, Treatment Group 5 |
| Cetirizine HCl placebo | Drug | Treatment Group 3, Treatment Group 5 |
Primary outcome
Change in average morning/evening (AM/PM) reflective Total Nasal Symptom Score (rTNSS)
Time frame: Change from baseline through the 2-week treatment period (Day 2 through Day 15)
Incidence of adverse events (AEs)
Time frame: From Screening period to Week 6 (Follow-up)
6 secondary outcomes
Change in average AM/PM instantaneous Total Nasal Symptom Score (iTNSS)
Time frame: Change from baseline through the 2-week treatment period (Day 2 through Day 15)
Change in average AM/PM Total Ocular Symptom Score
Time frame: Change from baseline through the 2-week treatment period (Day 2 through Day 15)
Assessment of Quality of Life
Time frame: Change from Week 3 to Week 5
Assessment of vital signs
Time frame: At Week 1 (Screening), Week 2, Week 3, Week 4, and Week 5
Assessment of clinical laboratory parameters
Time frame: At Week 1 (Screening), Week 4, Week 5, and Week 6 (Follow-up)
Assessment of electrocardiogram (ECG) findings
Time frame: At Week 1 (Screening) and Week 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shionogi Clinical Trials Administrator Clinical Support Help Line study director
Shionogi
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S-555739 Dose 1, S-555739 Dose 2 and Cetirizine HCl Dose 1 in people with Seasonal Allergic Rhinitis, run by Shionogi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in average morning/evening (AM/PM) reflective Total Nasal Symptom Score (rTNSS) (time frame: Change from baseline through the 2-week treatment period (Day 2 through Day 15)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2018.