RCT to Evaluate the Efficacy and Safety of Ivy Leaves Cough Liquid vs. Placebo in the Treatment of Acute Cough

NCT02396706 | Completed Phase 2

• 1 other identifier: EA-14-01-077
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Acute Cough

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS)

  whole treatment period over 7 days

Study Arms (2)

Ivy Leaves Cough Liquid

ACTIVE COMPARATOR

Ivy Leaves Cough Liquid

Drug: Ivy Leaves Cough Liquid

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Ivy Leaves Cough Liquid DRUG

Ivy Leaves Cough Liquid

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Engelhard Arzneimittel GmbH & Co.KG: lead

Study Sites (1)

Medizentrum Essen-Borbeck

Essen, Germany

Location

Study Officials

• Axel Schaefer

  Medizentrum Essen-Borbeck

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2015
• First Posted: March 24, 2015
• Study Start: January 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: September 3, 2015

Record last verified: 2015-09

Locations

DE (1)