Healthy VolunteersPhase 1NCT00893971

Study to Evaluate Single Inhaled Doses of PT001, PT003, PT005 and PT001 Plus PT005 in Healthy Subjects

A Phase 1 study testing PT001, PT005 and PT003 in people with Healthy Volunteers, run by Pearl Therapeutics, Inc. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate the safety of a single dose of PT003 compared with single doses of PT001 and PT005, and compared with PT001 plus PT005 delivered together as two separate single doses in healthy subjects. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: PT001, PT005 and PT003
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteAustralia
Study dates: May 2009to Jul 2009
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Provide signed written informed consent
18-55 years of age
Healthy subjects confirmed by medical history, physical examination, vital signs, pulmonary function tests, electrocardiogram and clinical laboratory tests
Female subjects of child-bearing potential who are sexually active must be willing to undergo a pregnancy test and agree to use two forms of contraception
Body mass index (BMI) between 18.5 and 30, inclusive
Non-smokers for at least 6 months prior to screening

Show all 9Show fewer

Pulmonary function tests within normal limits
Willing to remain at the study center for at least 12-24 hours on each test day
Venous access in both arms to allow collection of numerous blood samples

Who cannot join

Women who are pregnant or lactating
Clinically significant medical conditions
Viral illness within the last 30 days
Symptomatic prostatic hypertrophy or bladder neck obstruction
Known narrow-angle glaucoma
History of bowel obstruction

Show all 25Show fewer

Clinically significant abnormal electrocardiogram
Positive Hepatitis B surface antigen or positive Hepatitis C antibody
Positive screening test for HIV antibodies
History of hypersensitivity to any beta2-agonists, anticholinergics, or any component of the MDI
Known or suspected history of alcohol or drug abuse within the last 2-years
Greater than normal alcohol consumption
Ingestion of any poppy seeds within the 48 hours prior to the screening
Ingestion of any poppy seeds within the 48 hours prior to, or any alcohol, xanthines or grapefruit-containing foods or beverages within the 24 hours prior to, or during, each confinement
Positive breath alcohol result
Positive urine drug screen
Use of any beta2-agonists,or anticholinergics prior to the recruitment interview
Lower respiratory tract infections requiring antibiotics in the previous 6 weeks
Use of any other prescription medication
Use of any over the counter product, herbal product, diet aid, hormone supplement
Donation > 450 ml of blood within 8 weeks of first treatment dose
Clinically significant vital sign abnormality
Clinically significant biochemical, hematological or urinalysis abnormality
Affiliations with investigator site
Treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives prior to screening, whichever is longer

Trial locations and contacts

1 site in 1 country.

Australia1 site

Dr Joanne Marjason
Herston, Queensland, 4006

Other trials in Australia

About this study

Official title: A Randomized, Double-blind, Single Dose, Four-period, Four-treatment, Cross-over Study Evaluating the Safety of PT001, PT003, PT005 Administered Individually and PT001 + PT005 Delivered Together in Separate Inhalers in Healthy Subjects

Conditions: Healthy Volunteers
Being tested: PT001, PT005, PT003, PT001 + PT005
Keywords: Healthy Volunteers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PT001Drug
Inhaled PT001, single dose
PT005Drug
Inhaled PT005, single dose
PT003Drug
Inhaled PT003, single dose
PT001 + PT005Drug
Inhaled PT001 + PT005, single dose

Study groups in NCT00893971
Study group	Role	What they receive
1	Experimental	Inhaled PT001 18 μg Receives: Drug: PT001
2	Experimental	Inhaled PT005 2.4 μg Receives: Drug: PT005
3	Experimental	Inhaled PT003 (PT001 18 μg / 2.4 μg PT005) Receives: Drug: PT003
4	Experimental	PT001 18 μg + PT005 2.4 μg Receives: Drug: PT001 + PT005

What is being measured

The primary outcome is the main question the study is designed to answer.

Symptoms of Dry Mouth
Number of participants reporting dry mouth at 12 hours post-dose
Measured: 12 hours
Symptoms of Tremor
Number of participants reporting tremor at 12 hours post-dose
Measured: 12 hours
Blood Chemistry Change From Baseline
Series of 11 blood chemistries assessed throughout the study
Measured: 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects
Hematology Change From Baseline
Hematology assessments taken throughout the study Hematocrit
Measured: 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects
Hematology Change From Baseline
Hematology assessments taken throughout the study
Measured: 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects
Hematology Change From Baseline
Hematology assessments taken throughout the study Hemoglobin
Measured: 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects
Heart Rate Change From Baseline
Change from baseline for heart rate 12-hours post-dose Heart rate (bpm)
Measured: 12 hours
Vital Sign Change Baseline; Blood Pressure
Vital sign change baseline; blood pressure
Measured: 12 hours
Vital Sign Change From Baseline, SpO2
Vital Sign Change from baseline 12-hours post-dose SpO2 (%)
Measured: 12 hours
ECG Change From Baseline
Change from baseline for ECG parameters 12-hours post-dose Ventricular rate (bpm)
Measured: 12 hours
ECG Change From Baseline
Change from baseline for ECG parameters 12-hours post-dose
Measured: 12 hours
Spirometry Change From Baseline
Change from baseline for spirometery measures 12-hours post-dose
Measured: 12 hours
Spirometry Change From Baseline
Change from baseline for spirometery measures 12-hours post-dose (FEV1 % predicted)
Measured: 12 hours
Spirometry Change From Baseline
Change from baseline for spirometery measures 12-hours post-dose FEV/FVC (%)
Measured: 12 hours
Spirometry Change From Baseline
Change from baseline for spirometery measures 12-hours post-dose PEFR (L/min)
Measured: 12 hours
Serum Potassium Change From Baseline
Measured: 12 hours

Secondary outcomes (12)

Plasma Glycopyrrolate PK Parameters
Various pharmacokinetic parameters for plasma glycopyrrolate
Measured: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Plasma Glycopyrrolate PK Parameters AUC0-inf (h*pg/mL)
Various pharmacokinetic parameters for plasma glycopyrrolate
Measured: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Plasma Glycopyrrolate PK Parameters (Tmax)
Various pharmacokinetic parameters for plasma glycopyrrolate
Measured: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Plasma Glycopyrrolate PK Parameters (t1/2)
Various pharmacokinetic parameters for plasma glycopyrrolate
Measured: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Plasma Glycopyrrolate PK Parameters Cmax (pg/mL)
Various pharmacokinetic parameters for plasma glycopyrrolate
Measured: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Plasma Glycopyrrolate PK Parameters (ke)
Various pharmacokinetic parameters for plasma glycopyrrolate
Measured: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Plasma Formoterol PK Parameters
Various pharmacokinetic parameters for plasma formoterol
Measured: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Plasma Formoterol PK Parameters AUC0-inf (h*pg/mL)
Various pharmacokinetic parameters for plasma formoterol
Measured: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Plasma Formoterol PK Parameters (Tmax)
Various pharmacokinetic parameters for plasma formoterol
Measured: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Plasma Formoterol PK Parameters (t1/2)
Various pharmacokinetic parameters for plasma formoterol
Measured: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Plasma Formoterol PK Parameters (Cmax)
Pharmacokinetic parameters for plasma formoterol Cmax
Measured: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Plasma Formoterol PK Parameters (ke)
Pharmacokinetic parameters for plasma formoterol ke
Measured: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2009Jul 2009

First posted6 May 2009 (estimated)
Study startMay 2009
Primary completionJul 2009
Study completionJul 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteersStudies 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00893971
Sponsor's protocol ID: PT0030901
Status last verified: Mar 2017
First submitted: 5 May 2009
Last updated: 26 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Single Dose, Four-period, Four-treatment, Cross-over Study Evaluating the Safety of PT001, PT003, PT005 Administered Individually and PT001 + PT005 Delivered Together in Separate Inhalers in Healthy Subjects
ClinicalTrials.gov ID: NCT00893971
Acronym / sponsor ID: PT0030901
Conditions: Healthy Volunteers
Keywords: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Pearl Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: May 2009
Primary completion: Jul 2009 (actual)
Study completion: Jul 2009 (actual)
First posted: 6 May 2009 (estimated)
Results: Posted 26 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
1	Experimental	Drug: PT001Inhaled PT001 18 μg
2	Experimental	Drug: PT005Inhaled PT005 2.4 μg
3	Experimental	Drug: PT003Inhaled PT003 (PT001 18 μg / 2.4 μg PT005)
4	Experimental	Drug: PT001 + PT005PT001 18 μg + PT005 2.4 μg

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Provide signed written informed consent
18-55 years of age
Healthy subjects confirmed by medical history, physical examination, vital signs, pulmonary function tests, electrocardiogram and clinical laboratory tests
Female subjects of child-bearing potential who are sexually active must be willing to undergo a pregnancy test and agree to use two forms of contraception
Body mass index (BMI) between 18.5 and 30, inclusive

Key exclusion criteria (25 listed)

Women who are pregnant or lactating
Clinically significant medical conditions
Viral illness within the last 30 days
Symptomatic prostatic hypertrophy or bladder neck obstruction
Known narrow-angle glaucoma

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
PT001Inhaled PT001, single dose	Drug	1
PT005Inhaled PT005, single dose	Drug	2
PT003Inhaled PT003, single dose	Drug	3
PT001 + PT005Inhaled PT001 + PT005, single dose	Drug	4

Primary outcome

Symptoms of Dry Mouth
Time frame: 12 hours
Number of participants reporting dry mouth at 12 hours post-dose
Symptoms of Tremor
Time frame: 12 hours
Number of participants reporting tremor at 12 hours post-dose
Blood Chemistry Change From Baseline
Time frame: 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects
Series of 11 blood chemistries assessed throughout the study
Hematology Change From Baseline
Time frame: 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects
Hematology assessments taken throughout the study Hematocrit
Hematology Change From Baseline
Time frame: 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects
Hematology assessments taken throughout the study
Hematology Change From Baseline
Time frame: 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects
Hematology assessments taken throughout the study Hemoglobin
Heart Rate Change From Baseline
Time frame: 12 hours
Change from baseline for heart rate 12-hours post-dose Heart rate (bpm)
Vital Sign Change Baseline; Blood Pressure
Time frame: 12 hours
Vital sign change baseline; blood pressure
Vital Sign Change From Baseline, SpO2
Time frame: 12 hours
Vital Sign Change from baseline 12-hours post-dose SpO2 (%)
ECG Change From Baseline
Time frame: 12 hours
Change from baseline for ECG parameters 12-hours post-dose Ventricular rate (bpm)
ECG Change From Baseline
Time frame: 12 hours
Change from baseline for ECG parameters 12-hours post-dose
Spirometry Change From Baseline
Time frame: 12 hours
Change from baseline for spirometery measures 12-hours post-dose
Spirometry Change From Baseline
Time frame: 12 hours
Change from baseline for spirometery measures 12-hours post-dose (FEV1 % predicted)
Spirometry Change From Baseline
Time frame: 12 hours
Change from baseline for spirometery measures 12-hours post-dose FEV/FVC (%)
Spirometry Change From Baseline
Time frame: 12 hours
Change from baseline for spirometery measures 12-hours post-dose PEFR (L/min)
Serum Potassium Change From Baseline
Time frame: 12 hours

12 secondary outcomes

Plasma Glycopyrrolate PK Parameters
Time frame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Plasma Glycopyrrolate PK Parameters AUC0-inf (h*pg/mL)
Time frame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Plasma Glycopyrrolate PK Parameters (Tmax)
Time frame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Plasma Glycopyrrolate PK Parameters (t1/2)
Time frame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Plasma Glycopyrrolate PK Parameters Cmax (pg/mL)
Time frame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Plasma Glycopyrrolate PK Parameters (ke)
Time frame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Plasma Formoterol PK Parameters
Time frame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Plasma Formoterol PK Parameters AUC0-inf (h*pg/mL)
Time frame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Plasma Formoterol PK Parameters (Tmax)
Time frame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Plasma Formoterol PK Parameters (t1/2)
Time frame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Plasma Formoterol PK Parameters (Cmax)
Time frame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Plasma Formoterol PK Parameters (ke)
Time frame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose

Results and safety

Results posted to the registry on 26 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Overall Study	16	13

Primary outcome: Symptoms of Dry Mouth

Time frame: 12 hours. Number. Unit: Participants

Measure	Placebo + PT001 n = 15	Placebo + PT005 n = 13	PT001 + PT005 n = 16	Placebo + PT003 n = 15
Immediately pre-dose	3	1	3	1
30 minutes post-dose	4	3	4	5
1-hour post-dose	3	2	3	3
2-hours post-dose	3	1	3	1
4-hours post-dose	1	1	3	0
6-hours post-dose	1	1	2	NA
8-hours post-dose	1	1	2	NA
12-hours post-dose	1	1	2	NA

Population analysed: All subjects in the Safety Population

Primary outcome: Symptoms of Tremor

Time frame: 12 hours. Number. Unit: Participants

Measure	Placebo + PT001 n = 15	Placebo + PT005 n = 13	PT001 + PT005 n = 16	Placebo + PT003 n = 15
Immediately pre-dose	0	0	0	0
30-minutes post-dose	0	0	0	0
1-hour post-dose	0	0	0	0
2-hours post-dose	0	0	1	0
4-hours post-dose	NA	1	1	NA
6-hours post-dose	NA	0	0	NA
8-hours post-dose	NA	NA	NA	NA
12-hours post-dose	NA	NA	NA	NA

Population analysed: All subjects in the Safety Population

Primary outcome: Blood Chemistry Change From Baseline

Time frame: 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects. Mean (Full Range). Unit: mmol/L

Measure	Placebo + PT001 n = 15	Placebo + PT005 n = 13	PT001 + PT005 n = 16	Placebo + PT003 n = 15
Sodium	0.76 (-3 to 4)	0.78 (-1 to 3)	0.35 (-2 to 6)	0.6 (-2 to 3)
Chloride	-1.29 (-7 to 2)	-0.4 (-4 to 4)	-0.75 (-5 to 6)	-1.2 (-3 to 0)
Urea	0.12 (-0.9 to 1.4)	-0.05 (-1.3 to 1.8)	-0.11 (-2.6 to 1.5)	-0.33 (-3.3 to 1.1)
Calcium	-0.01 (-0.1 to 0.08)	-0.04 (-0.2 to 0.06)	-0.03 (-0.21 to 0.08)	-0.01 (-0.11 to 0.09)
Bicarbonate	0.64 (-2 to 4)	0.05 (-4 to 2)	0.44 (-5 to 6)	0.47 (-5 to 3)
Glucose	-0.17 (-2.5 to 1.1)	-0.34 (-2.4 to 1.2)	-0.34 (-2 to 1.1)	0.45 (-1.9 to 2.5)

Population analysed: All patients in the Safety Population that had a valid measurement for the parameter

Primary outcome: Blood Chemistry Change From Baseline

Time frame: 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects. Mean (Full Range). Unit: µmol/L

Measure	Placebo + PT001 n = 15	Placebo + PT005 n = 13	PT001 + PT005 n = 16	Placebo + PT003 n = 15
Creatinine	2.19 (-11 to 11)	1.45 (-15 to 12)	0.44 (-14 to 11)	-0.8 (-13 to 11)
Bilirubin	-1.4 (-6 to 3)	-2.18 (-5 to 0)	-2.32 (-6 to 1)	-2.07 (-10 to 2)

Population analysed: All subjects in the Safety Population that had a valid measurement for the parameter

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo + PT001	0 of 15 (0%)	7 of 15 (46.7%)	Not reported
Placebo + PT005	0 of 13 (0%)	6 of 13 (46.2%)	Not reported
PT001 + PT005	0 of 16 (0%)	8 of 16 (50%)	Not reported
Placebo + PT003	0 of 15 (0%)	9 of 15 (60%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Colin Reisner, M.D. study director

Pearl Therapeutics

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PT001, PT005 and PT003 in people with Healthy Volunteers, run by Pearl Therapeutics, Inc. at 1 site in Australia.

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 9 inclusion and 25 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 Apr 2017. 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 Australia. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Symptoms of Dry Mouth (time frame: 12 hours). The study lists 16 primary outcomes in all. 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 NCT00893971.

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 Apr 2017.