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

NCT02174653 | Completed Phase 3

• 2 other identifiers: 701079.01.0132013-004977-28
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Common Cold

Outcome Measures

Primary Outcomes (1)

• Occurrence of Adverse Drug Reactions (ADRs)

  during the 4 months treatment

Secondary Outcomes (3)

• Occurrence of Adverse Events (AEs) during the 4 months treatment

  Adverse events will be documented during the 4 months treatment period.

• Protective effects

  Protective effects will be evaluated during the 4 months treatment period.

• Effects during a cold episode

  Treatment effects on common cold symptoms will be documented for 14 days after onset of first common cold symptom

Study Arms (3)

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.

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.

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.

Drug: Placebo

Interventions

EPs® 7630 DRUG

20 mg EPs® 7630 film-coated tablets during 4 months Orally intake three times a day (in the morning, midday and evening)

Also known as: Pelargonium root liquid extract, dried

EPs(R) 7630; EPs® 7630

Placebo DRUG

Control: Placebo film coated tablets during 4 months Orally intake three times a day (in the morning, midday and evening)

EPs® 7630; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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):
• 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
• 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)

Sponsors & Collaborators

• Dr. Willmar Schwabe GmbH & Co. KG: lead

Study Sites (1)

Cardiff University, Common Cold Centre, Cardiff School of Biosciences

Cardiff, Wales, United Kingdom

Location

MeSH Terms

Conditions

Common Cold

Interventions

Desiccation

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chemistry Techniques, Analytical; Investigative Techniques; Chemical Phenomena

Study Officials

• Moutaz SM Jawad, M.B., B.Ch., FRCP

  Common Cold Centre, Cardiff School of Biosciences, Cardiff University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: June 25, 2014
• Study Start: March 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2016
• Last Updated: January 12, 2017

Record last verified: 2017-01

Locations

GB (1)