XerostomiaPhase 2NCT00637793
Study of NGX267 Oral Capsules in Patients With Xerostomia Associated With Sjorgren's Syndrome
A Phase 2 study testing NGX267 in people with Xerostomia and Sjogren's Syndrome, run by TorreyPines Therapeutics at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of NGX267 in the improvement of decreased salivary flow associated with primary or secondary Sjögren's syndrome. For each patient, the study includes four periods of treatment separated by a washout period that may range from 4 - 8 days according to patient… Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Xerostomia, Sjogren's Syndrome
- What is being tested?
- NGX267
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2008to Nov 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 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males and females aged 21 to 55 years, diagnosed with primary or secondary Sjögren's syndrome.
- Patients with a complaint of dry mouth based upon difficulty in speaking, swallowing, a sensation of mouth or throat dryness, lip or tongue dryness, or a level of thirst of sufficient intensity for the patient to seek therapy.
- Females of childbearing potential must not be at risk for pregnancy during the study. Females not of childbearing potential include postmenopausal and women who have been surgically sterilized.
- Patients must not be in an acute phase of illness.
Who cannot join
- Patients who have clinically significant reduction kidney function. cardiovascular abnormalities; lymphoma secondary to Sjögren's syndrome; pulmonary disease; the presence of enlarged salivary glands; physical closure of the salivary gland or known surgical procedure on the lacrimal punctum.
- Patients with diagnoses of a current gastrointestinal (GI) disease that would be exacerbated by the use of cholinomimetics; a current and acute psychiatric disorder, acute iritis, narrow angle glaucoma, or retinal disease as determined by medical history and physical examination.
- Patients who are otherwise judged inappropriate for inclusion in the study by the investigator
- Patients who have received any experimental drugs or devices or participated in any clinical trial within 30 days prior to screening including participation in a previous NGX267 clinical trial.
- Patients who are allergic to compounds that are similar to NGX267.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Walter F. Chase MD PA
Austin, Texas, 78705
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Penn Rheumatology Associates and Sjogren's Syndrome Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Double-Blind, Placebo-Controlled, Cross Over Study Using a Latin Square Design to Evaluate the Safety, Tolerability, and Efficacy of NGX267 Oral Capsules in Patients With Xerostomia Associated With Sjogren's Syndrome
The purpose of this study is to evaluate the effectiveness of NGX267 in the improvement of decreased salivary flow associated with primary or secondary Sjögren's syndrome.
For each patient, the study includes four periods of treatment separated by a washout period that may range from 4 - 8 days according to patient and site discretion. Each treatment period includes two overnight stays in the clinic. One dose of study drug is taken during each treatment period
- Conditions
- Xerostomia, Sjogren's Syndrome
- Being tested
- NGX267
- Keywords
- Xerostomia, Sjogren's Syndrome
- 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.
NGX267Drug
2 capsules in the am of each treatment period
NGX267Drug
2 capsules in the am of each treatment period
NGX267Drug
2 capsules in the am of each treatment period
NGX267Drug
2 capsules in the am of each treatment period
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo capsules Receives: Drug: NGX267 |
| 2 | Experimental | 2 capsules in the am of each treatment period Receives: Drug: NGX267 |
| 3 | Experimental | 2 capsules in the am of each treatment period Receives: Drug: NGX267 |
| 4 | Experimental | 2 capsules in am of each treatment period Receives: Drug: NGX267 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative and qualitative assessment of dry mouth
Measured: 36 days
Secondary outcomes (1)
Tolerability and safety of NGX267
Measured: 36 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2008 (estimated)
- Study startFeb 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for XerostomiaStudies 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
- Crossover
- Masking
- Double blind
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TorreyPines Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Walter F. Chase, M.D., Principal investigator, Walter F. Chase MD. PAAlan Kivitz, M.D., Principal investigator, Altoona Center for Clinical ResearchFrederick B. Vivino, M.D., Principal investigator, Penn Rheumatology Associates and Sjogren's Syndrome Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00637793
- Sponsor's protocol ID
- NGX267XSS2001
- Status last verified
- Jan 2009
- First submitted
- 11 Mar 2008
- Last updated
- 29 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Cross Over Study Using a Latin Square Design to Evaluate the Safety, Tolerability, and Efficacy of NGX267 Oral Capsules in Patients With Xerostomia Associated With Sjogren's Syndrome
- ClinicalTrials.gov ID
- NCT00637793
- Acronym / sponsor ID
- NGX267XSS2001
- Conditions
- Xerostomia, Sjogren's Syndrome
- Keywords
- Xerostomia, Sjogren's Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- TorreyPines TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Study completion
- Nov 2008 (actual)
- First posted
- 18 Mar 2008 (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 purpose of this study is to evaluate the effectiveness of NGX267 in the improvement of decreased salivary flow associated with primary or secondary Sjögren's syndrome.
For each patient, the study includes four periods of treatment separated by a washout period that may range from 4 - 8 days according to patient and site discretion. Each treatment period includes two overnight stays in the clinic. One dose of study drug is taken during each treatment period
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: NGX267Placebo capsules |
| 2 | Experimental | Drug: NGX2672 capsules in the am of each treatment period |
| 3 | Experimental | Drug: NGX2672 capsules in the am of each treatment period |
| 4 | Experimental | Drug: NGX2672 capsules in am of each treatment period |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males and females aged 21 to 55 years, diagnosed with primary or secondary Sjögren's syndrome.
- Patients with a complaint of dry mouth based upon difficulty in speaking, swallowing, a sensation of mouth or throat dryness, lip or tongue dryness, or a level of thirst of sufficient intensity for the patient to seek therapy.
- Females of childbearing potential must not be at risk for pregnancy during the study. Females not of childbearing potential include postmenopausal and women who have been surgically sterilized.
- Patients must not be in an acute phase of illness.
Key exclusion criteria (5 listed)
- Patients who have clinically significant reduction kidney function. cardiovascular abnormalities; lymphoma secondary to Sjögren's syndrome; pulmonary disease; the presence of enlarged salivary glands; physical closure of the salivary gland or known surgical procedure on the lacrimal punctum.
- Patients with diagnoses of a current gastrointestinal (GI) disease that would be exacerbated by the use of cholinomimetics; a current and acute psychiatric disorder, acute iritis, narrow angle glaucoma, or retinal disease as determined by medical history and physical examination.
- Patients who are otherwise judged inappropriate for inclusion in the study by the investigator
- Patients who have received any experimental drugs or devices or participated in any clinical trial within 30 days prior to screening including participation in a previous NGX267 clinical trial.
- Patients who are allergic to compounds that are similar to NGX267.
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 |
|---|---|---|
| NGX2672 capsules in the am of each treatment period | Drug | 2 |
| NGX2672 capsules in the am of each treatment period | Drug | 3 |
| NGX2672 capsules in the am of each treatment period | Drug | 1 |
| NGX2672 capsules in the am of each treatment period | Drug | 4 |
Primary outcome
Quantitative and qualitative assessment of dry mouth
Time frame: 36 days
1 secondary outcome
Tolerability and safety of NGX267
Time frame: 36 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 29 Jan 2009.
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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.
Walter F. Chase, M.D. principal investigator
Walter F. Chase MD. PA
Alan Kivitz, M.D. principal investigator
Altoona Center for Clinical Research
Frederick B. Vivino, M.D. principal investigator
Penn Rheumatology Associates and Sjogren's Syndrome Center
3 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 NGX267 in people with Xerostomia and Sjogren's Syndrome, run by TorreyPines Therapeutics at 3 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 4 inclusion and 5 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 29 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Quantitative and qualitative assessment of dry mouth (time frame: 36 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 29 Jan 2009; AzTrials last refreshed its copy on 8 Nov 2026.