Safety and Intake Effect of EPs® 7630 (an Extract of the Roots of Pelargonium Sidoides)

Dr. Willmar Schwabe

Status and phase: Completed; Phase 3

Conditions: Common Cold

Treatments: Drug: EPs® 7630; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02174653

701079.01.013

2013-004977-28 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 720 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Adult male or female participant (at least 18 years old)
2. Participant provided a written informed consent in accordance with the legal requirements
3. Participant with willingness and ability to comply with all procedures of the clinical trial and be available for the duration of the study
4. Participant is of good physical and mental condition
5. Participant experienced at least 2 colds per year in the last 12 months

Exclusion criteria

1. Chronic respiratory tract or lung disease (e.g. chronic bronchitis, COPD, bronchial asthma, cystic fibrosis, active pulmonary tuberculosis, lung cancer)

2. History of heart, renal, liver, neuromuscular disease and/or immunosuppression

3. Known allergic bronchial asthma

4. Known or suspected congenital anomalies of heart, kidney, liver, or mental disabilities

5. 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)

6. Women of child-bearing potential with no adequate and effective contraception (MHRA, 2010):

   • 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

7. Female participant who is pregnant, lactating or planning pregnancy during the course of the clinical trial

8. Participant with cold symptoms at inclusion

9. Current intake of antimicrobial and/or antiviral medication for any reason

10. Participant with known or suspected history of alcohol or drug abuse

11. Heavy smoking (more than 10 cigarettes per day)

12. Psychiatric disorders which may influence the results of the trial, epilepsy, or suicide attempts

13. Planned surgical intervention during the trial

14. 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

15. Known or suspected hypersensitivity to the active substance or to any of the excipients of the investigational product

16. Known clinically relevant laboratory abnormalities

17. Participant with increased tendency to bleed, especially nasal or gingival bleeding

18. Previous (within the last 3 months prior to visit 1) or concomitant treatment with coagulation-inhibiting drugs such as warfarin

19. Participation in a further clinical trial at the same time or within the last 4 weeks prior to inclusion into the present study

20. Previous randomisation in the present clinical study

21. Irresponsible subjects or those unable to understand nature, meaning and consequences of the trial

Trial design

720 participants in 3 patient groups, including a placebo group

EPs® 7630

Active Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: EPs® 7630

EPs(R) 7630

Active Comparator group

Description:

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.

Treatment:

Drug: EPs® 7630

Placebo

Placebo Comparator group

Description:

* 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.

Treatment:

Drug: Placebo