Dry Mouth Associated With Sjogren's SyndromePhase 2NCT00852839
A Safety and Efficacy Study of 552-02 in Subjects With Dry Mouth Associated With Sjogren's Syndrome
A Phase 2 study testing 552-02 in people with Dry Mouth Associated With Sjogren's Syndrome and Xerostomia, run by Parion Sciences at 15 sites in United States.
Trial summary
This clinical study is to determine whether daily administration of a formulation of 552-02 improves the dry mouth condition in subjects with primary Sjögren's syndrome. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dry Mouth Associated With Sjogren's Syndrome, Xerostomia
- What is being tested?
- 552-02
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 15 sitesUnited States
- Study dates
- Feb 2009to Nov 2009
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 18 to 80 years (inclusive), and capable of providing their written informed consent.
- Male subjects must be either not sexually active, surgically sterilized, or agree to use an appropriate "double-barrier" method during study participation and for at least 30 days after the completion of dosing.
- Non-pregnant female subjects must be either not sexually active, post-menopausal, surgically sterilized; or agree to use an appropriate "double-barrier" method; or are currently using a prescribed transdermal, injection, implant, or oral contraceptive for at least 30 days before study participation and at least 30 days after the completion of dosing.
- Good health, as determined by a medical history, a physical examination, a detailed oral examination, 12-lead ECG, and measurement of clinical chemistry, hematology, urinalysis, and serology data.
- Demonstrated minimal level of unstimulated whole mouth salivary flow (greater than or equal to 0.05 milliliters [ie, 0.05 grams] per 5 minutes).
- Demonstrated clinically significant, moderate to severe level of dry mouth at screening as determined by his/her score on a 100-mm global VAS of dry mouth symptoms with anchors ranging from 'not dry at all' (0) to 'dry as a desert' (100) as follows:
- Minimal VAS score of 50 mm at Visit 1.
- Diagnosis of primary Sjögren's syndrome.
Who cannot join
- Currently using a potassium-sparing diuretic antihypertensive drug that contains amiloride; spironolactone (e.g.,Aldactone, Novo-Spiroton, Spiractin, Spirtone, Verospiron or Berlactone); triamterene (e.g., Dyrenium); or plerenone (e.g., Inspra). Chronic use antihistamines will be permitted if started at least 30 days before Visit 1, and a stable dose is maintained throughout the trial.
- Started using systemic cholinergic secretagogues or tricyclic antidepressant drugs within 12 weeks before screening, is not on a stable dosing regimen for at least 14 days prior to the Screening visit, or who is unable to maintain stable dosing throughout the study.
- Unable to withhold the use of oral comfort agents (eg, Oasis, MouthKote, etc) following enrollment in the study (Visit 1).
- Shows evidence of a significant active or ongoing oral infection or other oral conditions (eg, lichen planus) that, in the opinion of the Investigator, might affect the safety of the subject or be exacerbated during study participation.
- Acutely infected salivary glands or suspected closure of the salivary glands.
- A condition that may confound the diagnosis of primary Sjögren's syndrome.
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- Received an investigational drug within the past 30 days.
- Received 552-02 in a previous study.
- History of multiple drug allergies or allergy to any medicine chemically related to the study drug (eg, amiloride, Moduretic, Midamor, triamterene).
- Any clinically significant allergic disease, including food allergies, with the exception of nonactive hayfever.
- Present history of any clinically significant and uncontrolled neurologic, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, or hematological disorder or disease, or any other major disorder or disease, in the opinion of the Investigator.
- Sitting blood pressure at screening higher than 150/90 mmHg or lower than 100/50 mmHg after resting for 5 minutes.
- Sitting pulse rate at screening outside the range of 50 - 90 beats per minute (bpm) after resting for 5 minutes.
- Consumes more than 2 alcoholic drinks per day or has a significant history of alcoholism or drug/chemical abuse within the past 12 months.
- History of using tobacco products within the last 3 months.
- Has viral hepatitis or tests positively for the hepatitis B surface antigen (HBsAg) or hepatitis C (non-A, non-B) antibody, or a positive result for human immunodeficiency virus (HIV) antibodies.
- Positive serum pregnancy test or is nursing (female subjects only).
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Tufts University School of Dental Medicine
Boston, Massachusetts, 02111
Carolinas Medical Center
Charlotte, North Carolina, 26232
Arthritis Centers of Texas
Dallas, Texas, 75246
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
University of Florida College of Dentristy
Gainesville, Florida, 32610
Indiana School of Dentristy
Indianapolis, Indiana, 46202
Rheumatology Consultants
Knoxville, Tennessee, 37909
Winthrop University Hospital
Mineola, New York, 11501
Oklahoma University
Oklahoma City, Oklahoma, 73104
Penn Rheumatology Associates
Philadelphia, Pennsylvania, 19104
AAIR Research Center
Rochester, New York, 14518
Univ. of Texas Health Science Center
San Antonio, Texas, 78229
Arthritis Northwest
Spokane, Washington, 99204
New England Research Associates, LLC
Trumbull, Connecticut, 06611
The Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902
About this study
Official title: A Randomized, Double-Blind, Vehicle-Controlled, Parallel Arm Study of 552-02 in Subjects With Dry Mouth Associated With Sjogren's Syndrome
This clinical study is to determine whether daily administration of a formulation of 552-02 improves the dry mouth condition in subjects with primary Sjögren's syndrome.
Read the detailed description
The primary objective of this clinical study is to determine whether daily administration of an oromucosal formulation of 552-02 improves the global assessment of dry mouth, as assessed by visual analog scale (VAS), in subjects with primary Sjögren's syndrome.
The secondary objectives of this study are as follows:
- To evaluate the safety of daily administration of an oromucosal formulation of 552-02 in subjects with primary Sjögren's syndrome.
- To evaluate whether administration of an oromucosal formulation of 552-02 improves the subjective measurement of 6 different salivary functions, as measured using VAS, in subjects with primary Sjögren's syndrome.
- Being tested
- Placebo, 552-02
- Keywords
- Dry mouth, Sjogren's syndrome, Xerostomia
- Medical subject headings
- Xerostomia, Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo to match oromucosal formulation of 552-02
552-02Drug
The oromucosal formulation of 552-02 contains 552-02 (25 μg/mL), surfactant, flavoring agents, a humectant, and preservatives.
| Study group | Role | What they receive |
|---|---|---|
| 552-02 | Experimental | Not described Receives: Drug: 552-02 |
| 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.
Global assessment of dry mouth, as assessed by visual analog scale (VAS), in subjects with primary Sjögren's syndrome.
Measured: 49 Days
Secondary outcomes (1)
To evaluate the safety of daily administration of an oromucosal formulation of 552-02 in subjects with primary Sjögren's syndrome.
Measured: 49 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionOct 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Mouth Associated With Sjogren's SyndromeStudies 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
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parion Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852839
- Sponsor's protocol ID
- 552-207S
- Status last verified
- Jul 2014
- First submitted
- 26 Feb 2009
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Vehicle-Controlled, Parallel Arm Study of 552-02 in Subjects With Dry Mouth Associated With Sjogren's Syndrome
- ClinicalTrials.gov ID
- NCT00852839
- Acronym / sponsor ID
- 552-207S
- Keywords
- Dry mouth, Sjogren's syndrome, Xerostomia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Parion SciencesIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 27 Feb 2009 (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 clinical study is to determine whether daily administration of a formulation of 552-02 improves the dry mouth condition in subjects with primary Sjögren's syndrome.
Detailed description
The primary objective of this clinical study is to determine whether daily administration of an oromucosal formulation of 552-02 improves the global assessment of dry mouth, as assessed by visual analog scale (VAS), in subjects with primary Sjögren's syndrome.
The secondary objectives of this study are as follows:
- To evaluate the safety of daily administration of an oromucosal formulation of 552-02 in subjects with primary Sjögren's syndrome.
- To evaluate whether administration of an oromucosal formulation of 552-02 improves the subjective measurement of 6 different salivary functions, as measured using VAS, in subjects with primary Sjögren's syndrome.
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 |
|---|---|---|
| 552-02 | Experimental | Drug: 552-02 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female, aged 18 to 80 years (inclusive), and capable of providing their written informed consent.
- Male subjects must be either not sexually active, surgically sterilized, or agree to use an appropriate "double-barrier" method during study participation and for at least 30 days after the completion of dosing.
- Non-pregnant female subjects must be either not sexually active, post-menopausal, surgically sterilized; or agree to use an appropriate "double-barrier" method; or are currently using a prescribed transdermal, injection, implant, or oral contraceptive for at least 30 days before study participation and at least 30 days after the completion of dosing.
- Good health, as determined by a medical history, a physical examination, a detailed oral examination, 12-lead ECG, and measurement of clinical chemistry, hematology, urinalysis, and serology data.
- Demonstrated minimal level of unstimulated whole mouth salivary flow (greater than or equal to 0.05 milliliters [ie, 0.05 grams] per 5 minutes).
Key exclusion criteria (17 listed)
- Currently using a potassium-sparing diuretic antihypertensive drug that contains amiloride; spironolactone (e.g.,Aldactone, Novo-Spiroton, Spiractin, Spirtone, Verospiron or Berlactone); triamterene (e.g., Dyrenium); or plerenone (e.g., Inspra). Chronic use antihistamines will be permitted if started at least 30 days before Visit 1, and a stable dose is maintained throughout the trial.
- Started using systemic cholinergic secretagogues or tricyclic antidepressant drugs within 12 weeks before screening, is not on a stable dosing regimen for at least 14 days prior to the Screening visit, or who is unable to maintain stable dosing throughout the study.
- Unable to withhold the use of oral comfort agents (eg, Oasis, MouthKote, etc) following enrollment in the study (Visit 1).
- Shows evidence of a significant active or ongoing oral infection or other oral conditions (eg, lichen planus) that, in the opinion of the Investigator, might affect the safety of the subject or be exacerbated during study participation.
- Acutely infected salivary glands or suspected closure of the salivary glands.
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 |
|---|---|---|
| PlaceboPlacebo to match oromucosal formulation of 552-02 | Drug | Placebo |
| 552-02The oromucosal formulation of 552-02 contains 552-02 (25 μg/mL), surfactant, flavoring agents, a humectant, and preservatives. | Drug | 552-02 |
Primary outcome
Global assessment of dry mouth, as assessed by visual analog scale (VAS), in subjects with primary Sjögren's syndrome.
Time frame: 49 Days
1 secondary outcome
To evaluate the safety of daily administration of an oromucosal formulation of 552-02 in subjects with primary Sjögren's syndrome.
Time frame: 49 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 18 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
15 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 552-02 in people with Dry Mouth Associated With Sjogren's Syndrome and Xerostomia, run by Parion Sciences at 15 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 8 inclusion and 17 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 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
Global assessment of dry mouth, as assessed by visual analog scale (VAS), in subjects with primary Sjögren's syndrome. (time frame: 49 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 18 Sep 2018.