Common ColdPhase 3NCT02174653
Safety and Intake Effect of EPs® 7630 (an Extract of the Roots of Pelargonium Sidoides)
A Phase 3 study testing EPs® 7630 in people with Common Cold, run by Dr. Willmar Schwabe GmbH & Co. KG at 1 site in United Kingdom.
Trial summary
The aim of the study is to evaluate the safety of the intake of EPs® 7630 during a long-term (4 months) medication. The protective effects of EPs®7630 and its effects during a cold episode will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Common Cold
- What is being tested?
- EPs® 7630
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 720 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2014to Aug 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult male or female participant (at least 18 years old)
- Participant provided a written informed consent in accordance with the legal requirements
- Participant with willingness and ability to comply with all procedures of the clinical trial and be available for the duration of the study
- Participant is of good physical and mental condition
- Participant experienced at least 2 colds per year in the last 12 months
Who cannot join
- Chronic respiratory tract or lung disease (e.g. chronic bronchitis, COPD, bronchial asthma, cystic fibrosis, active pulmonary tuberculosis, lung cancer)
- History of heart, renal, liver, neuromuscular disease and/or immunosuppression
- Known allergic bronchial asthma
- Known or suspected congenital anomalies of heart, kidney, liver, or mental disabilities
- Participant with concomitant medications that might impair the interpretation of trial results (e.g. herbal medications for common cold other than the investigational product, or pain relief medications other than Paracetamol or Ibuprofen)
- Women of child-bearing potential with no adequate and effective contraception (MHRA, 2010):
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- Established use of oral, injected or implanted hormonal methods of contraception
- Placement of an intrauterine device (IUD) or intrauterine system (IUS)
- Barrier methods of contraception: Condom and/or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
- Sexual abstinence
- Vasectomised partner
- Female participant who is pregnant, lactating or planning pregnancy during the course of the clinical trial
- Participant with cold symptoms at inclusion
- Current intake of antimicrobial and/or antiviral medication for any reason
- Participant with known or suspected history of alcohol or drug abuse
- Heavy smoking (more than 10 cigarettes per day)
- Psychiatric disorders which may influence the results of the trial, epilepsy, or suicide attempts
- Planned surgical intervention during the trial
- Known gastrointestinal disorders with uncertain absorption of orally administered medication (e.g. partial or total gastrectomy, enterectomy, inflammatory bowel disease, celiac disease, symptomatic lactose intolerance, dysbacteriosis) or associated with diarrhoea
- Known or suspected hypersensitivity to the active substance or to any of the excipients of the investigational product
- Known clinically relevant laboratory abnormalities
- Participant with increased tendency to bleed, especially nasal or gingival bleeding
- Previous (within the last 3 months prior to visit 1) or concomitant treatment with coagulation-inhibiting drugs such as warfarin
- Participation in a further clinical trial at the same time or within the last 4 weeks prior to inclusion into the present study
- Previous randomisation in the present clinical study
- Irresponsible subjects or those unable to understand nature, meaning and consequences of the trial
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cardiff University, Common Cold Centre, Cardiff School of Biosciences
Cardiff, Wales
About this study
Official title: Safety and Intake Effect of EPs® 7630 (an Extract of the Roots of Pelargonium Sidoides) A Prospective, Monocentric, Randomised, Double-blind, Placebo-controlled Clinical Trial
The aim of the study is to evaluate the safety of the intake of EPs® 7630 during a long-term (4 months) medication. The protective effects of EPs®7630 and its effects during a cold episode will also be studied.
Read the detailed description
The main objective of this clinical trial is to evaluate the safety of EPs® 7630 intake - used as continuous protection and at the onset of cold symptoms - in adult participants during a long-term (4 months) medication. Due to the sparseness of empirical data in the population and this setting, no confirmatory hypotheses are formulated and the data will be analysed descriptively.
- Conditions
- Common Cold
- Being tested
- EPs® 7630, Placebo
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPs® 7630Drug
Also called Pelargonium root liquid extract, dried
20 mg EPs® 7630 film-coated tablets during 4 months Orally intake three times a day (in the morning, midday and evening)
PlaceboDrug
Control: Placebo film coated tablets during 4 months Orally intake three times a day (in the morning, midday and evening)
| Study group | Role | What they receive |
|---|---|---|
| EPs® 7630 | Active comparator | Active Comparator 20 mg EPs® 7630 film-coated tablet
* During the common cold free period: One film-coated tablet (20 mg) three times a day
* During a common cold episode: Two film-coated tablets (1 x 20 mg and 1x placebo) three times a day (in the morning, midday and evening; total daily dose 60 mg) over the individual treatment duration of 14 consecutive days. Receives: Drug: EPs® 7630; Drug: Placebo |
| EPs(R) 7630 | Active comparator | Active Comparator 20 mg EPs® 7630 film-coated tablet
* During the common cold free period: One film-coated tablet (20 mg) three times a day
* During a common cold episode: Two film-coated tablets (2 x 20 mg = 40 mg) three times a day (in the morning, midday and evening; total daily dose 120 mg) over the individual treatment duration of 14 consecutive days. Receives: Drug: EPs® 7630 |
| Placebo | Placebo comparator | * During the common cold free period: One film-coated tablet (placebo) three times a day
* During a common cold episode: Two film-coated tablet (placebo) three times a day (in the morning, midday and evening) over the individual treatment duration of 14 consecutive days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Adverse Drug Reactions (ADRs)
Measured: during the 4 months treatment
Secondary outcomes (3)
Occurrence of Adverse Events (AEs) during the 4 months treatment
Measured: Adverse events will be documented during the 4 months treatment period.
Protective effects
Time to onset of first common cold symptoms, time between last common cold episode prior to trial entry and first cold episode during the trial, total number of common cold episodes, total number of participants with at least one / more than one common cold episode
Measured: Protective effects will be evaluated during the 4 months treatment period.
Effects during a cold episode
Mean cold episode duration (in days), cumulative episode days, number of co-medicated cold episodes, number of patients with respiratory complications due to common cold, development of the total cold symptom score and of single symptoms during a cold episode
Measured: Treatment effects on common cold symptoms will be documented for 14 days after onset of first common cold symptom
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startMar 2014
- Primary completionJul 2015
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common ColdStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 720 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Willmar Schwabe GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Moutaz SM Jawad, M.B., B.Ch., FRCP, Principal investigator, Common Cold Centre, Cardiff School of Biosciences, Cardiff University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174653
- Sponsor's protocol ID
- 701079.01.013
- Other IDs
- 2013-004977-28
- Status last verified
- Jan 2017
- First submitted
- 2 Jun 2014
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Intake Effect of EPs® 7630 (an Extract of the Roots of Pelargonium Sidoides) A Prospective, Monocentric, Randomised, Double-blind, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02174653
- Acronym / sponsor ID
- 701079.01.013
- Conditions
- Common Cold
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 720 participants (actual)
- Lead sponsor
- Dr. Willmar Schwabe GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 25 Jun 2014 (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 aim of the study is to evaluate the safety of the intake of EPs® 7630 during a long-term (4 months) medication. The protective effects of EPs®7630 and its effects during a cold episode will also be studied.
Detailed description
The main objective of this clinical trial is to evaluate the safety of EPs® 7630 intake - used as continuous protection and at the onset of cold symptoms - in adult participants during a long-term (4 months) medication. Due to the sparseness of empirical data in the population and this setting, no confirmatory hypotheses are formulated and the data will be analysed descriptively.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EPs® 7630 | Active comparator | Drug: EPs® 7630, Drug: PlaceboActive Comparator 20 mg EPs® 7630 film-coated tablet * During the common cold free period: One film-coated tablet (20 mg) three times a day * During a common cold episode: Two film-coated tablets (1 x 20 mg and 1x placebo) three times a day (in the morning, midday and evening; total daily dose 60 mg) over the individual treatment duration of 14 consecutive days. |
| EPs(R) 7630 | Active comparator | Drug: EPs® 7630Active Comparator 20 mg EPs® 7630 film-coated tablet * During the common cold free period: One film-coated tablet (20 mg) three times a day * During a common cold episode: Two film-coated tablets (2 x 20 mg = 40 mg) three times a day (in the morning, midday and evening; total daily dose 120 mg) over the individual treatment duration of 14 consecutive days. |
| Placebo | Placebo comparator | Drug: Placebo* During the common cold free period: One film-coated tablet (placebo) three times a day * During a common cold episode: Two film-coated tablet (placebo) three times a day (in the morning, midday and evening) over the individual treatment duration of 14 consecutive days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult male or female participant (at least 18 years old)
- Participant provided a written informed consent in accordance with the legal requirements
- Participant with willingness and ability to comply with all procedures of the clinical trial and be available for the duration of the study
- Participant is of good physical and mental condition
- Participant experienced at least 2 colds per year in the last 12 months
Key exclusion criteria (26 listed)
- Chronic respiratory tract or lung disease (e.g. chronic bronchitis, COPD, bronchial asthma, cystic fibrosis, active pulmonary tuberculosis, lung cancer)
- History of heart, renal, liver, neuromuscular disease and/or immunosuppression
- Known allergic bronchial asthma
- Known or suspected congenital anomalies of heart, kidney, liver, or mental disabilities
- Participant with concomitant medications that might impair the interpretation of trial results (e.g. herbal medications for common cold other than the investigational product, or pain relief medications other than Paracetamol or Ibuprofen)
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 |
|---|---|---|
| EPs® 7630Also: Pelargonium root liquid extract, dried20 mg EPs® 7630 film-coated tablets during 4 months Orally intake three times a day (in the morning, midday and evening) | Drug | EPs(R) 7630, EPs® 7630 |
| PlaceboControl: Placebo film coated tablets during 4 months Orally intake three times a day (in the morning, midday and evening) | Drug | EPs® 7630, Placebo |
Primary outcome
Occurrence of Adverse Drug Reactions (ADRs)
Time frame: during the 4 months treatment
3 secondary outcomes
Occurrence of Adverse Events (AEs) during the 4 months treatment
Time frame: Adverse events will be documented during the 4 months treatment period.
Protective effects
Time frame: Protective effects will be evaluated during the 4 months treatment period.
Effects during a cold episode
Time frame: Treatment effects on common cold symptoms will be documented for 14 days after onset of first common cold symptom
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 2017.
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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.
Moutaz SM Jawad, M.B., B.Ch., FRCP principal investigator
Common Cold Centre, Cardiff School of Biosciences, Cardiff University
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 EPs® 7630 in people with Common Cold, run by Dr. Willmar Schwabe GmbH & Co. KG at 1 site in United Kingdom.
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 5 inclusion and 26 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 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 United Kingdom. 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 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?
Occurrence of Adverse Drug Reactions (ADRs) (time frame: during the 4 months treatment). 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 12 Jan 2017.