CoughPhase 3NCT00380315
Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of AG1321001 in Chronic Cougher
A Phase 3 study testing AG1321001(drug) in people with Cough, run by Ahn-Gook Pharmaceuticals Co.,Ltd at 1 site in South Korea.
Trial summary
This study is for therapeutic confirmation of AG1321001 to evaluate the safety and efficacy as an anti-tussive agent in cough patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cough
- What is being tested?
- AG1321001(drug)
- How many people
- 396 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2006to Jun 2007
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult between the ages of 18 and 70.
- Patient who has cough symptom caused by following diseases: chronic bronchitis, bronchiectasis, gastroesophageal reflux disease, postnasal drip syndrome caused by rhinitis, sinusitis, rhinopharyngitis, rhinolaryngitis.
- Patient requiring internal treatment due to cough symptom, who has coughing more than 3 weeks.
- patient who will continue to cough more than 1 week.(by physician's judgment)
- Patient who decided to participate in this clinical trial at his(her) own will and agreed in written letter of consent.
- Patient who is trustworthy, ready for cooperation and observing the restrictions during the trial period.
Who cannot join
- Patient who is accompanied by the seriously abnormal symptom in respiratory system, such as Acute infectious Pulmonary Disease, Tuberculosis.
- Patient who has clinical history of sensitivity to Xanthine drug.
- Patient who has Peptic Ulcer or Asthma (Except Cicatrix)
- Patient whose liver or kidney function is seriously abnormal: Including the cases of sGOT, sGPT, bilirubin and blood creatinine value exceeding twice of their upper normal limit.
- Patient whose heart function is abnormal: including the case of showing abnormal EKG test value that is clinically significant.
- Patient who has experience to have participated in other clinical trial within two months before starting the trial.
Show all 9Show fewer
- Pregnant woman, lactating woman.
- patient who has convulsion or alcoholism.
- patient who take medicines which can not use combination with AG1321001.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of AG1321001 Capsule as an Anti-Tussive Agent in Cough Patients: Double Blinded, Randomized, Placebo and Active Rug Comparative, Parallel Designed Phase III Study
This study is for therapeutic confirmation of AG1321001 to evaluate the safety and efficacy as an anti-tussive agent in cough patients.
- Conditions
- Cough
- Being tested
- AG1321001(drug)
- Keywords
- Cough, Chronic bronchitis, PNDs, Post Nasal Drip syndrome, GERD, gastroesophageal reflux disease, bronchiectasis
- Medical subject headings
- Cough, Bronchitis, Chronic, upper airway cough syndrome, Gastroesophageal Reflux, Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AG1321001(drug)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Cough severity, Cough specific Quality of Life
Secondary outcomes (1)
Daily cough symptom, Cough frequency
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2006 (estimated)
- Study startMar 2006
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 396 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahn-Gook Pharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Young-hwan Kim, MD, PhD, Study chair, Seoul National University Hospital, Seoul, 110-744, Korea, Republic ofChoon-Taek Lee, MD, PhD, Principal investigator, Seoul National University Bundang Hospital, Sungnam, Korea, Republic ofHee-Soon Chung, MD, PhD, Principal investigator, Seoul National University Boramae Hospital, Seoul, 156-707, Korea, Republic ofKi-suk Jung, MD, PhD, Principal investigator, Hallym University Sacred Heart Hospital, Anyang, Kyunggi, 430-070, Korea, Republic ofJoon Chang, MD, PhD, Principal investigator, Severance Hospital, Seoul, 120-752, Korea, Republic ofChul-min Ahn, MD, PhD, Principal investigator, Yongdong Sevenrance Hospital, Seoul, 135-720, Korea, Republic of
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00380315
- Sponsor's protocol ID
- AG1321001_P302
- Status last verified
- Jun 2009
- First submitted
- 21 Sep 2006
- Last updated
- 2 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of AG1321001 Capsule as an Anti-Tussive Agent in Cough Patients: Double Blinded, Randomized, Placebo and Active Rug Comparative, Parallel Designed Phase III Study
- ClinicalTrials.gov ID
- NCT00380315
- Acronym / sponsor ID
- AG1321001_P302
- Conditions
- Cough
- Keywords
- Cough, Chronic bronchitis, PNDs, Post Nasal Drip syndrome, GERD, gastroesophageal reflux disease, bronchiectasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 396 participants (actual)
- Lead sponsor
- Ahn-Gook Pharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Study completion
- Jun 2007 (actual)
- First posted
- 25 Sep 2006 (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 study is for therapeutic confirmation of AG1321001 to evaluate the safety and efficacy as an anti-tussive agent in cough patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult between the ages of 18 and 70.
- Patient who has cough symptom caused by following diseases: chronic bronchitis, bronchiectasis, gastroesophageal reflux disease, postnasal drip syndrome caused by rhinitis, sinusitis, rhinopharyngitis, rhinolaryngitis.
- Patient requiring internal treatment due to cough symptom, who has coughing more than 3 weeks.
- patient who will continue to cough more than 1 week.(by physician's judgment)
- Patient who decided to participate in this clinical trial at his(her) own will and agreed in written letter of consent.
Key exclusion criteria (9 listed)
- Patient who is accompanied by the seriously abnormal symptom in respiratory system, such as Acute infectious Pulmonary Disease, Tuberculosis.
- Patient who has clinical history of sensitivity to Xanthine drug.
- Patient who has Peptic Ulcer or Asthma (Except Cicatrix)
- Patient whose liver or kidney function is seriously abnormal: Including the cases of sGOT, sGPT, bilirubin and blood creatinine value exceeding twice of their upper normal limit.
- Patient whose heart function is abnormal: including the case of showing abnormal EKG test value that is clinically significant.
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 |
|---|---|---|
| AG1321001(drug) | Drug | – |
Primary outcome
Cough severity, Cough specific Quality of Life
1 secondary outcome
Daily cough symptom, Cough frequency
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 2 Jul 2009.
- Related InfoLink provided by the sponsor.
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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.
Young-hwan Kim, MD, PhD study chair
Seoul National University Hospital, Seoul, 110-744, Korea, Republic of
Choon-Taek Lee, MD, PhD principal investigator
Seoul National University Bundang Hospital, Sungnam, Korea, Republic of
Hee-Soon Chung, MD, PhD principal investigator
Seoul National University Boramae Hospital, Seoul, 156-707, Korea, Republic of
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AG1321001(drug) in people with Cough, run by Ahn-Gook Pharmaceuticals Co.,Ltd at 1 site in South Korea.
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 6 inclusion and 9 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 2 Jul 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 South Korea. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Cough severity, Cough specific Quality of Life. 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 2 Jul 2009.