Seasonal Allergic RhinitisPhase 2STA-2NCT01171664
Clinical Trial of STAHIST in Seasonal Allergic Rhinitis (SAR) Subjects
A Phase 2 study testing STAHIST in people with Seasonal Allergic Rhinitis, run by Magna Pharmaceuticals, Inc. at 2 sites in United States.
Trial summary
To report and compare total symptom scores, nasal symptom scores, post-nasal drip symptom scores, and adverse reactions in and between SAR subjects on active drug and SAR subjects on placebo. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- STAHIST
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2010to Jan 2011
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males and females of any ethnic group between 18 and 60 years of age.
- History of moderate to severe SAR for at least two years.
- Subjects' symptoms resulting from the irritation of sinus, nasal and upper respiratory tract tissues will include the five symptoms that are th focus of this study: nasal congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip. Subjects must have a TSS baseline score of at least 8 on the S5 Subject Diary.
- Prior to study drug administration, subjects' good health will be confirmed by medical history and physical examination, including pregnancy test (urine dip) before study inception.
- Allergic hypersensitivity will be confirmed by the physician or well established patient medical history.
- Subject's compliance with requisite run-in period for each subject will be confirmed by investigator/designee.
Who cannot join
- Pregnancy or lactation.
- Immunotherapy unless at a stable maintenance dose.
- Presence of a medical condition that might interfere with treatment evaluation or require a change in therapy including but not limited to high blood pressure or urinary retention problems.
- Alcohol dependence.
- Use of any other investigational drug in the previous month.
- Subjects presenting with asthma requiring corticosteroid treatment.
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- Subjects with multiple drug allergies.
- Subjects known to have an idiosyncratic reaction to any of the ingredients in IMP (STAHIST).
- Subject who is participating in any other clinical study.
- Subject who is unable to meet washout requirements.
- Subject with clinically significant abnormal vital sign or laboratory value that precludes participation.
- Subject with any family relationship to the sponsor, investigator, or staff of sponsor or investigator.
- A URI within 4 weeks of study inception.
- Subjects taking beta blockers or try-cyclic antidepressants. -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Family Allergy & Asthma Research Institute
Louisville, Kentucky, 40215
The South Bend Clinic
South Bend, Indiana, 46617
About this study
Official title: A Bi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of STAHIST in Adult Subjects With a History of Seasonal Allergic Rhinitis
To report and compare total symptom scores, nasal symptom scores, post-nasal drip symptom scores, and adverse reactions in and between SAR subjects on active drug and SAR subjects on placebo.
Read the detailed description
This double-blind, placebo-controlled study will evaluate the efficacy and safety of STAHIST vs. placebo over a 2-week period in 100 study subjects with a history of SAR for at least two years. The study will take place in two sites, Louisville, KY and South Bend, IN. SAR symptoms to be scored and compared include: nasal congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Placebo, STAHIST
- Keywords
- Phase 2, SAR, STAHIST
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Tablet, one BID
STAHISTDrug
STAHIST in tablet form dosed one BID
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo containing no active pharmaceutical ingredients Receives: Drug: Placebo |
| STAHIST | Experimental | STAHIST tablet for the symptomatic treatment of Seasonal Allergic Rhinitis Receives: Drug: STAHIST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Symptom Scores(TSS)reported and compared between the two study arms
TSS includes the sum of nasal congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip
Measured: Twice daily over the 2 week study period
Secondary outcomes (1)
Adverse events--report and assess
Any/all adverse events will be recorded and scored, reported, evaluated, and results will be clinically and statistically compared between the placebo and active drug arms.
Measured: Continuous over the two week study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2010 (estimated)
- Study startSep 2010
- Primary completionOct 2010
- Study completionJan 2011
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.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Magna Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen J Pollard, MD, Principal investigator, Family Allergy & Asthma Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01171664
- Sponsor's protocol ID
- 105781-2
- Acronym
- STA-2
- Status last verified
- Sep 2010
- First submitted
- 27 Jul 2010
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of STAHIST in Adult Subjects With a History of Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT01171664
- Acronym / sponsor ID
- STA-2 / 105781-2
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- Phase 2, SAR, STAHIST
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Magna Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 28 Jul 2010 (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.
To report and compare total symptom scores, nasal symptom scores, post-nasal drip symptom scores, and adverse reactions in and between SAR subjects on active drug and SAR subjects on placebo.
Detailed description
This double-blind, placebo-controlled study will evaluate the efficacy and safety of STAHIST vs. placebo over a 2-week period in 100 study subjects with a history of SAR for at least two years. The study will take place in two sites, Louisville, KY and South Bend, IN. SAR symptoms to be scored and compared include: nasal congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo containing no active pharmaceutical ingredients |
| STAHIST | Experimental | Drug: STAHISTSTAHIST tablet for the symptomatic treatment of Seasonal Allergic Rhinitis |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Males and females of any ethnic group between 18 and 60 years of age.
- History of moderate to severe SAR for at least two years.
- Subjects' symptoms resulting from the irritation of sinus, nasal and upper respiratory tract tissues will include the five symptoms that are th focus of this study: nasal congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip. Subjects must have a TSS baseline score of at least 8 on the S5 Subject Diary.
- Prior to study drug administration, subjects' good health will be confirmed by medical history and physical examination, including pregnancy test (urine dip) before study inception.
- Allergic hypersensitivity will be confirmed by the physician or well established patient medical history.
Key exclusion criteria (14 listed)
- Pregnancy or lactation.
- Immunotherapy unless at a stable maintenance dose.
- Presence of a medical condition that might interfere with treatment evaluation or require a change in therapy including but not limited to high blood pressure or urinary retention problems.
- Alcohol dependence.
- Use of any other investigational drug in the previous month.
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 |
|---|---|---|
| PlaceboTablet, one BID | Drug | Placebo |
| STAHISTSTAHIST in tablet form dosed one BID | Drug | STAHIST |
Primary outcome
Total Symptom Scores(TSS)reported and compared between the two study arms
Time frame: Twice daily over the 2 week study period
TSS includes the sum of nasal congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip
1 secondary outcome
Adverse events--report and assess
Time frame: Continuous over the two week study period
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 26 Mar 2014.
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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.
Stephen J Pollard, MD principal investigator
Family Allergy & Asthma Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing STAHIST in people with Seasonal Allergic Rhinitis, run by Magna Pharmaceuticals, Inc. at 2 sites in United States.
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 6 inclusion and 14 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 26 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Total Symptom Scores(TSS)reported and compared between the two study arms (time frame: Twice daily over the 2 week study period). 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 26 Mar 2014.