Chronic SinusitisPhase 2NCT00447837
Evaluating SPRC-AB01 in Post-Surgical Subjects With Chronic Sinusitis
A Phase 2 study testing SPRC-AB01 in people with Chronic Sinusitis, run by Naryx Pharma at 43 sites in United States.
Trial summary
The primary objective of the study is to evaluate the safety and efficacy of SPRC-AB01 versus placebo for treatment of chronic sinusitis in subjects who have had sinus surgery. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Chronic Sinusitis
- What is being tested?
- SPRC-AB01
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 43 sitesUnited States
- Study dates
- Oct 2006to Jan 2008
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Outpatient subjects who have signed a written informed consent.
- A documented history of chronic sinusitis with clinical signs and symptoms suggestive of inflammation or infection for at least 90 consecutive days.
- A documented history of sinus surgery > 90 days.
- Nasal endoscopic exam documenting purulence (pus) from an open sinus cavity with mucosal swelling/edema.
- Women of childbearing potential must have a negative serum pregnancy test and must use adequate birth control throughout the study.
Who cannot join
- Pregnant females and females unwilling to use adequate birth control.
- Use of any investigational drug/device within 30 days of study screening.
- The following medications will require a certain washout period as determined by the protocol: systemic corticosteroids, mast cells and/or leukotriene inhibitors, anti-inflammatories, decongestants, antihistamines, non-steroidal anti-inflammatory (NSAID) or cyclooxygenase (COX)-2 inhibitors, antibiotics or antifungals.
- Presence of other infections which may require use of systemic antibiotics.
- Known allergy or hypersensitivity to aminoglycosides or other study drug formulation components.
- Recent hospitalization for any reason and/or major surgeries within 30 days of study screening.
Show all 15Show fewer
- Major elective and/or nasal and/or sinus surgical procedures (including sinuplasty) within 90 days before or 90 days after study screening.
- Known history of neurological or muscular disorders.
- Diagnosis of an immunodeficiency disease.
- Previous diagnosis of cystic fibrosis, ciliary dyskinesias, Kartagener syndrome, empty nose syndrome, Wegener granulomatosis, Churg-Strauss syndrome, Samter syndrome, or sarcoidosis.
- Current or known history of tinnitus, vertigo, or significant sensorineural hearing loss.
- Recent history of alcohol or drug abuse.
- Inability to understand the nature, scope, and possible consequences of the study or study procedures, unless cared for by a legally authorized representative.
- Inability to adhere to the study requirements.
- Previous participation in any Naryx Pharma protocol.
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
United States43 sites
Nasal Sinus and Allergy Institute
Alpharetta, Georgia, 30004
Clinical Trials Management LLC
Boca Raton, Florida, 33487
Massachusetts General Hospital - Allergy Clinical Research
Boston, Massachusetts, 02114
Clinical Research Group of Montana
Bozeman, Montana, 59718
The Connecticut Sinus Center
Bridgeport, Connecticut, 06606
1st Allergy & Clinical Research Center
Centennial, Colorado, 80112
Charlotte Eye, Ear, Nose & Throat Associates
Charlotte, North Carolina, 28210
Cleveland Clinic - Head & Neck Institute
Cleveland, Ohio, 44195
Colorado Otolaryngology Associates
Colorado Springs, Colorado, 80909
Ear, Nose & Throat Associates of Corpus Christi / Research
Corpus Christi, Texas, 78411
Henry Ford Health System
Detroit, Michigan, 48202
Allergy & Asthma Center / South Florida ENT
Fort Lauderdale, Florida, 33334
Central California Clinical Research
Fresno, California, 93720
Northeast Georgia Research Center
Gainsville, Georgia, 30501
ADAC Research PA
Greenville, South Carolina, 29607
Allergy & Sinus Center
Greenwood, Mississippi, 38930
Clinical Research Consultants
Hoover, Alabama, 35216
Allergy and Asthma Associates
Houston, Texas, 77054
The Jackson Clinic
Jackson, Tennessee, 38301
NEA Clinic
Jonesboro, Arkansas, 72401
The Allergy, Asthma & Sinus Center
Knoxville, Tennessee, 37909
Shah Eye Ear Nose & Throat
Lawrenceville, New Jersey, 08648
Allergy Research Foundation, Inc
Los Angeles, California, 90025
Commonwealth Ear, Nose & Throat
Louisville, Kentucky, 40207
Marshfield Clinic
Marshfield, Wisconsin, 54449
Weill Medical College-Department of Otorhinolaryngology
New York, New York, 10021
Children's Hospital of Orange County
Orange, California, 92868
University of Pittsburgh - The Eye and Ear Institute
Pittsburgh, Pennsylvania, 15213
Research Across America
Plano, Texas, 75093
Clinical Research Institute
Plymouth, Minnesota, 55441
Calvert Internal Medicine Group
Prince Frederick, Maryland, 20678
University of Rochester-Otolaryngology Associates
Rochester, New York, 14618
Allergy Medical Group of the North Area Inc
Roseville, California, 95678
Northside Ear, Nose & Throat
Roswell, Georgia, 30076
Sacramento Ear, Nose & Throat
Sacramento, California, 95815
San Antonio Ear, Nose and Throat Research
San Antonio, Texas, 78229
Allergy & Asthma Medical Group and Research Center
San Diego, California, 92123
ENT Care
Somerville, New Jersey, 08876
Toledo Center for Clinical Research
Sylvania, Ohio, 43560
Clinical Research of West Florida
Tampa, Florida, 33603
Center for Allergy and Asthma of Bronx and Westchester
The Bronx, New York, 10465
Marshfield Clinic - Weston Center
Weston, Wisconsin, 54476
Wilmington Health Associates
Wilmington, North Carolina, 28405
About this study
Official title: A Phase 2, Double-Blind, Placebo-Controlled, Multi-Center, Randomized Study Evaluating the Safety and Efficacy of SPRC-AB01, Tobramycin Solution for Nasal Inhalation, in Post-Surgical Subjects With Chronic Sinusitis
The primary objective of the study is to evaluate the safety and efficacy of SPRC-AB01 versus placebo for treatment of chronic sinusitis in subjects who have had sinus surgery.
- Conditions
- Chronic Sinusitis
- Being tested
- SPRC-AB01
- Keywords
- Chronic Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPRC-AB01Drug
90 mg/3 mL BID, 180 mg/3 mL bid, placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: SPRC-AB01 |
| 2 | Experimental | Not described Receives: Drug: SPRC-AB01 |
| 3 | Placebo comparator | Not described Receives: Drug: SPRC-AB01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in TSSS during first week post-therapy
Measured: 86 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2007 (estimated)
- Study startOct 2006
- Primary completionDec 2007
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic SinusitisStudies 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Naryx Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00447837
- Sponsor's protocol ID
- SPRC-AB01-003
- Status last verified
- Dec 2007
- First submitted
- 13 Mar 2007
- Last updated
- 17 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-Blind, Placebo-Controlled, Multi-Center, Randomized Study Evaluating the Safety and Efficacy of SPRC-AB01, Tobramycin Solution for Nasal Inhalation, in Post-Surgical Subjects With Chronic Sinusitis
- ClinicalTrials.gov ID
- NCT00447837
- Acronym / sponsor ID
- SPRC-AB01-003
- Conditions
- Chronic Sinusitis
- Keywords
- Chronic Sinusitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Naryx PharmaIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 15 Mar 2007 (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 is to evaluate the safety and efficacy of SPRC-AB01 versus placebo for treatment of chronic sinusitis in subjects who have had sinus surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SPRC-AB01 |
| 2 | Experimental | Drug: SPRC-AB01 |
| 3 | Placebo comparator | Drug: SPRC-AB01 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Outpatient subjects who have signed a written informed consent.
- A documented history of chronic sinusitis with clinical signs and symptoms suggestive of inflammation or infection for at least 90 consecutive days.
- A documented history of sinus surgery > 90 days.
- Nasal endoscopic exam documenting purulence (pus) from an open sinus cavity with mucosal swelling/edema.
- Women of childbearing potential must have a negative serum pregnancy test and must use adequate birth control throughout the study.
Key exclusion criteria (15 listed)
- Pregnant females and females unwilling to use adequate birth control.
- Use of any investigational drug/device within 30 days of study screening.
- The following medications will require a certain washout period as determined by the protocol: systemic corticosteroids, mast cells and/or leukotriene inhibitors, anti-inflammatories, decongestants, antihistamines, non-steroidal anti-inflammatory (NSAID) or cyclooxygenase (COX)-2 inhibitors, antibiotics or antifungals.
- Presence of other infections which may require use of systemic antibiotics.
- Known allergy or hypersensitivity to aminoglycosides or other study drug formulation components.
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 |
|---|---|---|
| SPRC-AB0190 mg/3 mL BID, 180 mg/3 mL bid, placebo | Drug | 1, 2, 3 |
Primary outcome
Change from baseline in TSSS during first week post-therapy
Time frame: 86 days
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 17 Mar 2008.
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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.
43 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 SPRC-AB01 in people with Chronic Sinusitis, run by Naryx Pharma at 43 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 5 inclusion and 15 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 17 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 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?
Change from baseline in TSSS during first week post-therapy (time frame: 86 days). 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 17 Mar 2008.