Acute CoughPhase 2NCT00547846

A Phase II Clinical Study of PDC-748 in Patients With Acute Cough

A Phase 2 study testing PDC-748 in people with Acute Cough, run by PhytoHealth Corporation at 1 site in Taiwan.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 20 years and older
Conditions the study is for: Acute Cough
What is being tested?: PDC-748
How many people: Not given
Where: 1 siteTaiwan
Study dates: Oct 2007to not given
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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients diagnosed with acute cough ;
Men or women aged ≥ 20 years old;
Patients with Cough Symptom Score(daytime) between 2 and 4, inclusively;
Patients are willing and able to comply with the study procedures and sign the informed consent.

Who cannot join

Patients with chronic cough ;
Patients with chronic airway disease;
Patients with respiratory tract malignancy;
Patients with clinically suspected low respiratory tract infection;
Patients with abnormal liver or kidney functions
Patients taking antitussives, sleeping pills, sedative medications, or herbal products;

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Pregnant or breastfeeding patients; female patients of child bearing potential who do not agree to practice effective birth control;
Patient's symptom of acute cough may be due to heart failure or may be induced by other medications such as ACE inhibitor medications, as determined by the investigator;
Patients who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with the assessments of safety or efficacy during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, immune, neurological, or hematological disease as determined by the clinical judgment of the investigator;
Use of any investigational drug or participation of any clinical trial within 28 days prior to this study.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Chang-Gung Memorial Hospital,Taiwan
Taipei City/ Taoyuan County, Taiwan,ROC, 105

Other trials in Taiwan

About this study

The pharmacological effects of PDC-748 were tested in numerous in vitro and in vivo studies. The existing pharmacologic findings suggest that PDC-748 possesses certain inhibitory activity to the citric acid- and capsaicin-induced cough reflex in guinea pigs with a dose-dependent manner. Furthermore, a previous Phase I/II uncontrolled, dose-escalating study has shown PDC-748 to be well tolerated and may help to alleviate daytime cough with a dose-responding manner.Hence, PhytoHealth Corporation intends to carry out a Phase II investigation to confirm the preliminary findings using placebo in the comparator group, and to further investigate PDC-748 with a dose escalating manner to establish the dose-response range for its antitussive effect, and if possible, to determine the maximal tolerable dose of PDC-748.

This is a randomized, double-blind, placebo-controlled, dose escalating study to evaluate the safety and efficacy of the escalating dose levels of PDC-748 in patients with acute cough.

Conditions: Acute Cough
Being tested: PDC-748
Keywords: Cough, Antitussive, PDC-748, PhytoHealth
Medical subject headings: Cough

What participants receive

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

PDC-748Drug

Timeline

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

Oct 2007?

First posted23 Oct 2007 (estimated)
Study startOct 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Acute CoughStudies 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: Factorial
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator

IDs, dates and publications

ClinicalTrials.gov ID: NCT00547846
Sponsor's protocol ID: PH-CP013
Other IDs: SBIR: 2Z950430
Status last verified: Jan 2009
First submitted: 22 Oct 2007
Last updated: 12 Jan 2009
Results posted: No
Data monitoring committee: Yes

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?

See locations

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All Acute Cough trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Clinical Study of PDC-748 in Patients With Acute Cough
ClinicalTrials.gov ID: NCT00547846
Acronym / sponsor ID: PH-CP013
Conditions: Acute Cough
Keywords: Cough, Antitussive, PDC-748, PhytoHealth
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Lead sponsor: PhytoHealth CorporationIndustry (pharma, biotech, devices)
Study start: Oct 2007
First posted: 23 Oct 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.

This is a randomized, double-blind, placebo-controlled, dose escalating study to evaluate the safety and efficacy of the escalating dose levels of PDC-748 in patients with acute cough.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind (participant, care provider, investigator)

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients diagnosed with acute cough ;
Men or women aged ≥ 20 years old;
Patients with Cough Symptom Score(daytime) between 2 and 4, inclusively;
Patients are willing and able to comply with the study procedures and sign the informed consent.

Key exclusion criteria (10 listed)

Patients with chronic cough ;
Patients with chronic airway disease;
Patients with respiratory tract malignancy;
Patients with clinically suspected low respiratory tract infection;
Patients with abnormal liver or kidney functions

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
PDC-748	Drug	–

Primary outcome

Not reported in the source record.

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 12 Jan 2009.

Related trials for Acute Cough

Not yet recruiting
Optimizing Dysphagia Treatment Delivery in Acute Care: A Hybrid Efficacy Implementation Trial
Dysphagia, Critical Illness
Not yet recruiting
Regional Thoracoabdominal Mobility Responses to Integrated Myofascial Release in Healthy Adults
Thoracoabdominal Mobility
Not yet recruiting
Acute and Long-Term Effects of Integrated Myofascial Release Therapy on Respiratory Function in Healthy Adults
Respiratory Function
Enrolling by invitationObservational study
Multimodal Digital Biomarker Prediction of Acute Clinical Deterioration
Acute Disease, Disease Progression
Recruiting
The Use of Functional Electrical Stimulation in Conjunction With Respiratory Muscle Training to Improve Unaided Cough in Individuals With Acute Spinal Cord Injury
Acute Spinal Cord Injury

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.

Ying-Huang Tsai, M.D. principal investigator

Chang Gung Memorial Hospital

Ying Huang Tsai, PI principal investigator

Chang Gung Memorial Hospital

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PDC-748 in people with Acute Cough, run by PhytoHealth Corporation at 1 site in Taiwan.

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 10 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 12 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 1 site in Taiwan. 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 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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00547846.

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 12 Jan 2009.