Allergic RhinitisPhase 2NCT01614691
Safety and Efficacy of SPARC1203 in Allergic Rhinitis
A Phase 2 study testing SPARC1203 in people with Allergic Rhinitis, run by Sun Pharma Advanced Research Company Limited at 1 site in Germany.
Trial summary
This study will assess safety and efficacy of SPARC1203 delivered via nasal spray in patients with allergic rhinitis Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- SPARC1203
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2012to Mar 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients aged 18 to 65 years (both inclusive) with history of seasonal allergic rhinitis and positive skin prick test
Who cannot join
- History or presence of perennial allergic rhinitis
- Upper or lower respiratory tract infection 2 weeks before Visit 2
- Significant pulmonary disease other than allergic rhinitis or mild asthma controlled by beta-2-agonists alone
- Immunizations or vaccinations within 4 weeks prior to Visit 1
Trial locations and contacts
1 site in 1 country.
About this study
This study will assess safety and efficacy of SPARC1203 delivered via nasal spray in patients with allergic rhinitis
- Conditions
- Allergic Rhinitis
- Being tested
- SPARC1203, Placebo
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPARC1203Drug
Active
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| SPARC1203 low dose | Experimental | Not described Receives: Drug: SPARC1203 |
| SPARC1203 mid dose | Experimental | Not described Receives: Drug: SPARC1203 |
| SPARC1203 high dose | Experimental | Not described Receives: Drug: SPARC1203 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Nasal Symptom Score (TNSS)
Measured: Baseline and 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionNov 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- 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
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharma Advanced Research Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01614691
- Sponsor's protocol ID
- CLR_12_03
- Status last verified
- May 2019
- First submitted
- 6 Jun 2012
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Badorrek P, Hohlfeld JM, Krug N, Joshi A, Raut A. Efficacy and safety of a novel nasal steroid, S0597, in patients with seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2015 Oct;115(4):325-329.e1. doi: 10.1016/j.anai.2015.07.016. Epub 2015 Aug 11.
PubMed 26272281
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of SPARC1203 in Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT01614691
- Acronym / sponsor ID
- CLR_12_03
- Conditions
- Allergic Rhinitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Sun Pharma Advanced Research Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 8 Jun 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.
This study will assess safety and efficacy of SPARC1203 delivered via nasal spray in patients with allergic rhinitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SPARC1203 low dose | Experimental | Drug: SPARC1203 |
| SPARC1203 mid dose | Experimental | Drug: SPARC1203 |
| SPARC1203 high dose | Experimental | Drug: SPARC1203 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and female patients aged 18 to 65 years (both inclusive) with history of seasonal allergic rhinitis and positive skin prick test
Key exclusion criteria (4 listed)
- History or presence of perennial allergic rhinitis
- Upper or lower respiratory tract infection 2 weeks before Visit 2
- Significant pulmonary disease other than allergic rhinitis or mild asthma controlled by beta-2-agonists alone
- Immunizations or vaccinations within 4 weeks prior to Visit 1
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 |
|---|---|---|
| SPARC1203Active | Drug | SPARC1203 high dose, SPARC1203 low dose, SPARC1203 mid dose |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Change in Total Nasal Symptom Score (TNSS)
Time frame: Baseline and 2 weeks
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 3 May 2019.
- Derived from this study: PubMed 26272281Badorrek P, Hohlfeld JM, Krug N, Joshi A, Raut A. Efficacy and safety of a novel nasal steroid, S0597, in patients with seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2015 Oct;115(4):325-329.e1. doi: 10.1016/j.anai.2015.07.016. Epub 2015 Aug 11.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SPARC1203 in people with Allergic Rhinitis, run by Sun Pharma Advanced Research Company Limited at 1 site in Germany.
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 1 inclusion and 4 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 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Total Nasal Symptom Score (TNSS) (time frame: Baseline and 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01614691, which also lists 1 linked publication.
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 3 May 2019.