Acute CoughPhase 2NCT02396706
RCT to Evaluate the Efficacy and Safety of Ivy Leaves Cough Liquid vs. Placebo in the Treatment of Acute Cough
A Phase 2 study testing Ivy Leaves Cough Liquid in people with Acute Cough, run by Engelhard Arzneimittel GmbH & Co.KG at 1 site in Germany.
Trial summary
Randomized, controlled, double-blind, multi-center trial to evaluate the efficacy and safety of a liquid containing ivy leaves dry extract vs. placebo in the treatment of acute cough Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Cough
- What is being tested?
- Ivy Leaves Cough Liquid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 181 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2015to Jun 2015
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute cough with symptoms lasting 2-3 days prior to treatment
- Men or women of any ethnic origin
- Age 18 to 75 years
- Subjects who are able to understand and are willing to comply to trial instructions
- Having given written informed consent
- Satisfactory health except for the cough as determined by the investigator based on medical history and physical examination
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- CS score of at least 50 mm on a 100 mm VAS at V1
- Acute BSS of at least 10 points at V1
- VCD score of at least 2 points at V1
Who cannot join
- Allergic bronchial asthma, bronchial hyperreactivity, chronic bronchitis, other chronic or inherited lung disease
- History of hypersensitivity to any excipient of the applied drugs
- History of drug hypersensitivity, asthma, urticaria, or other severe allergic diathesis as well as current hay fever
- History of chronic gastritis or peptic ulcers
- Any gastrointestinal complaints within 7 days before V1
- Participation in a clinical trial within 30 days prior to the treatment phase of this study or concomitantly
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- Treatment with corticoids, beta-2 agonists (e.g. salbutamol, fenoterol), expectorants, theophylline, antitussives, anaesthetics, acetylsalicylic acid (e.g. aspirin) or other non-steroidal anti-inflammatory drugs, leukotriene inhibitors, angiotensin-converting enzyme (ACE) inhibitors, antiviral drugs or antibiotics, antihistamines, immunosuppressants, isoprenaline, atropine, sodium cromoglycate or homeopathic drugs against common cold within 7 days before V1
- Drug or alcohol abuse in the opinion of the investigator
- Pregnant or nursing (lactating) women
- Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) who are not using an acceptable method of contraception.
- Subjects with significant diseases, defined as a disease which, in the opinion of the investigator, may either put the subject at risk because of participation in the trial or a disease which may influence the results of the trial or the subject's ability to participate in the trial; includes subjects with a history of gastrointestinal bleeding, significant cardiovascular, liver or renal disease.
- Subjects directly or indirectly involved in the execution of this protocol, including employees of the CRO and persons related to them.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Controlled, Double-blind, Multi-center Trial to Evaluate the Efficacy and Safety of a Liquid Containing Ivy Leaves Dry Extract vs. Placebo in the Treatment of Acute Cough
Randomized, controlled, double-blind, multi-center trial to evaluate the efficacy and safety of a liquid containing ivy leaves dry extract vs. placebo in the treatment of acute cough
- Conditions
- Acute Cough
- Being tested
- Ivy Leaves Cough Liquid, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivy Leaves Cough LiquidDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Ivy Leaves Cough Liquid | Active comparator | Ivy Leaves Cough Liquid Receives: Drug: Ivy Leaves Cough Liquid |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
Measured: whole treatment period over 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2015
- Study completionJun 2015
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Engelhard Arzneimittel GmbH & Co.KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Axel Schaefer, Principal investigator, Medizentrum Essen-Borbeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396706
- Sponsor's protocol ID
- EA-14-01-077
- Status last verified
- Sep 2015
- First submitted
- 18 Mar 2015
- Last updated
- 3 Sep 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Double-blind, Multi-center Trial to Evaluate the Efficacy and Safety of a Liquid Containing Ivy Leaves Dry Extract vs. Placebo in the Treatment of Acute Cough
- ClinicalTrials.gov ID
- NCT02396706
- Acronym / sponsor ID
- EA-14-01-077
- Conditions
- Acute Cough
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Engelhard Arzneimittel GmbH & Co.KGIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 24 Mar 2015 (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.
Randomized, controlled, double-blind, multi-center trial to evaluate the efficacy and safety of a liquid containing ivy leaves dry extract vs. placebo in the treatment of acute cough
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ivy Leaves Cough Liquid | Active comparator | Drug: Ivy Leaves Cough LiquidIvy Leaves Cough Liquid |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Acute cough with symptoms lasting 2-3 days prior to treatment
- Men or women of any ethnic origin
- Age 18 to 75 years
- Subjects who are able to understand and are willing to comply to trial instructions
- Having given written informed consent
Key exclusion criteria (12 listed)
- Allergic bronchial asthma, bronchial hyperreactivity, chronic bronchitis, other chronic or inherited lung disease
- History of hypersensitivity to any excipient of the applied drugs
- History of drug hypersensitivity, asthma, urticaria, or other severe allergic diathesis as well as current hay fever
- History of chronic gastritis or peptic ulcers
- Any gastrointestinal complaints within 7 days before V1
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 |
|---|---|---|
| Ivy Leaves Cough Liquid | Drug | Ivy Leaves Cough Liquid |
| Placebo | Drug | Placebo |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: whole treatment period over 7 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 3 Sep 2015.
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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.
Axel Schaefer principal investigator
Medizentrum Essen-Borbeck
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 Ivy Leaves Cough Liquid in people with Acute Cough, run by Engelhard Arzneimittel GmbH & Co.KG at 1 site in Germany.
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 12 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 3 Sep 2015. 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 Germany. 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?
Visual Analogue Scale (VAS) (time frame: whole treatment period over 7 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 3 Sep 2015.