Efficacy and Safety Study of Homeopathic Oral Antibodies to Treat Viral Upper Respiratory Tract Infections (ESTUAR)
This study is currently recruiting participants.
Verified May 2013 by Theranor s.p.r.l
Sponsor:
Theranor s.p.r.l
Information provided by (Responsible Party):
Theranor s.p.r.l
ClinicalTrials.gov Identifier:
NCT01651715
First received: July 25, 2012
Last updated: May 2, 2013
Last verified: May 2013
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Purpose
The purpose of this study is to determine whether early self-treatment with homeopathic dilutions of oral antibodies to a key-protein of the immune system are effective and safe in the treatment of viral upper respiratory tract infections
| Condition | Intervention | Phase |
|---|---|---|
|
Common Cold |
Drug: TAO1, oral homeopathic antibodies |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Multicentre, Randomised, Double-blind, Parallel, Placebo-controlled Study Evaluating the Efficacy and Safety of Early Self-Treatment of Viral Upper Respiratory Tract Infections With Homeopathic Oral Antibodies to the TLR3 FYW Peptide (TAO1) |
Resource links provided by NLM:
Further study details as provided by Theranor s.p.r.l:
Primary Outcome Measures:
- Severity of symptoms of common cold [ Time Frame: Since start of symptoms of common cold up to the visit 3 (day 10-14) ] [ Designated as safety issue: No ]Decrease in severity is assessed as reduction in average area under the curve (AUC) under the time severity curve (sum of all WURSS scores over the follow-up). The Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) is a validated tool to evaluate the duration and severity of common cold. It is constituted of twenty-one categorical questions (Likert-type 7-level severity scale).
Secondary Outcome Measures:
- Duration of common cold [ Time Frame: Since start of symptoms of common cold up to visit 3 (Day 10-14) ] [ Designated as safety issue: No ]Duration is defined as the number of days from self-reported onset of disease to the last day before the participant answered "Not sick" to the question, "How sick do you feel today?" (WURSS-21). A 2-day reduction in average disease duration versus placebo will be regarded as clinically significant.
- Functional impairments in the course of the disease [ Time Frame: Since start of symptoms of common cold up to visit 3 (Day 10-14) ] [ Designated as safety issue: No ]Day-to-day scores for functional impairments domain. Overall (sum of all WURSS scores related to functional impairments over the follow-up).
- The need of symptomatic analgesics/antipyretics [ Time Frame: Since start of symptoms of common cold up to visit 3 (Day 10-14) ] [ Designated as safety issue: Yes ]Patients will fill in diary cards on a daily basis. The following information will be recorded: study and patient identification, date of assessment, study medication intake, other medications (name, dose, frequency) and, AEs/SAEs (description)
- Evaluation of safety [ Time Frame: since start of symptoms of common cold up to visit 3 (Day 10-14) ] [ Designated as safety issue: Yes ]Patients will fill in diary cards on a daily basis including AEs/SAEs reporting. Investigators will question patients at phone call and scheduled visits about AEs/SAEs. Frequency, severity, outcome and relationship to the study drug will be assessed.
| Estimated Enrollment: | 240 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: TAO1, oral homeopathic antibodies
TAO1 is an investigational medicinal product containing homeopathic dilutions (<10-24M) of antibodies purified from the serum of rabbit immunised against a synthetic peptide with an amino acid sequence selected in the human toll-like receptor type 3 sequence (anti-TLR3). It is intended for the treatment of viral Upper Respiratory Tract Infections (URTIs) such as common cold, influenza or influenza-like illnesses.
|
Drug: TAO1, oral homeopathic antibodies
TAO1 comprises a mixture of homeopathic dilutions C12+C30+C200 (drug product is made by impregnation of pre-made tablets). The investigational product will be taken for 7 days as follow: Day 1: 3 tablets over the first 2 hours of treatment, then 3 tablets over the rest of Day 1. Days 2-3: 5 tablets/day (intakes distributed evenly over the daytime). Days 4-7: 3 tablets/day (intakes distributed evenly over the daytime). |
|
Placebo Comparator: Placebo
Same characteristics as investigational medicinal Product except for homeopathic dilutions of oral antibodies to the TLR3 FYW peptide
|
Drug: TAO1, oral homeopathic antibodies
TAO1 comprises a mixture of homeopathic dilutions C12+C30+C200 (drug product is made by impregnation of pre-made tablets). The investigational product will be taken for 7 days as follow: Day 1: 3 tablets over the first 2 hours of treatment, then 3 tablets over the rest of Day 1. Days 2-3: 5 tablets/day (intakes distributed evenly over the daytime). Days 4-7: 3 tablets/day (intakes distributed evenly over the daytime). |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Outpatients aged > or = 18 years
- Ability and willingness to adhere to the study protocol
- Signed informed consent
- Self-reported recently emerged symptoms of common cold: answer "Yes" to the question "Do you believe that you are coming down with a cold?"
- At least one of the following 4 common cold symptoms: sneezing, runny nose, nasal obstruction and/or sore throat, with no limitations of symptom severity.
Exclusion Criteria:
- Specific chronic diseases (autoimmune disease, chronic bronchitis, human immunodeficiency virus (HIV) infection, lupus, rheumatoid arthritis)
- Malignancy for which the patient has undergone resection, radiation or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed.
- Cancer therapy
- Immunosuppressant therapies
- Use of systemic corticosteroids
- A history of asthma or allergic rhinitis and corresponding symptoms (itchy eyes, sneezing, wheezing)
- Any of the common cold symptoms persisting since more than 36 hours
- Use of other homeopathic drugs designed to treat URTIs
- Use of antibiotics, anti-histaminergic drugs or decongestants
- Participation in another clinical trial within one month prior to treatment start
- Previous participation (receipt of randomised treatment) in this study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01651715
Contacts
| Contact: Stéphane Heijmans, MD | 003223830455 | stephane.heijmans@researchlink.be |
Locations
| Belgium | |
| Frank Heyvaert | Terminated |
| Deurne, Antwerpen, Belgium, 2100 | |
| Hugo Loos | Recruiting |
| Geel, Antwerpen, Belgium, 2440 | |
| Contact: Hugo Loos, MD 003214852810 hugo.loos@telenet.be | |
| Principal Investigator: Hugo Loos, MD | |
| Christel Van Der Geer | Recruiting |
| Geel, Antwerpen, Belgium, 2440 | |
| Contact: Christel Van Der Geer, MD 003214581603 cvdgeer@skynet.be | |
| Principal Investigator: Christel Van Der Geer, MD | |
| Jan Joris | Recruiting |
| Mol, Antwerpen, Belgium, 2400 | |
| Contact: Jan Joris, MD 003214347777 drjoris@hcmillegem.be | |
| Principal Investigator: Jan Joris, MD | |
| Jan De Jongh | Recruiting |
| Vorst, Antwerpen, Belgium, 2430 | |
| Contact: Jan De Jongh, MD 003213662153 jandejongh@hotmail.com | |
| Principal Investigator: Jan De Jongh, MD | |
| Jean-Pierre Devaux | Terminated |
| Baisy-Thy, Brabant, Belgium, 1470 | |
| Virginie Risse | Recruiting |
| Bruxelles, Brabant, Belgium, 1180 | |
| Contact: Virginie Risse, MD 003223723679 virginie.risse@skynet.be | |
| Principal Investigator: Virginie Risse, MD | |
| Roel De Ryck | Recruiting |
| Kraainem, Brabant, Belgium, 1950 | |
| Contact: Roel De Ryck, MD 003227316180 deryckro@hotmail.com | |
| Principal Investigator: Roel De Ryck, MD | |
| ResearchLink sprl | Recruiting |
| Linkebeek, Brabant, Belgium, 1630 | |
| Contact: Stéphane Heijmans, MD 003223830455 stephane.heijmans@researchlink.be | |
| Contact: Béatrice Schmitz 003223830455 beatrice.schmitz@researchlink.be | |
| Principal Investigator: Stéphane Heijmans, MD | |
| Principal Investigator: Olivier Maury, MD | |
| Stéphane Vanden Bemden | Recruiting |
| Melsbroek, Brabant, Belgium, 1820 | |
| Contact: Stéphane Vanden Bemden, MD 003227517725 stephane.vanden.bemden@telenet.be | |
| Principal Investigator: Stéphane Vanden Bemden, MD | |
| Bart Van Essche | Terminated |
| Steenokkerzeel, Brabant, Belgium, 1820 | |
| Lode Vermeersch | Recruiting |
| Tremelo, Brabant, Belgium, 3120 | |
| Contact: Lode Vermeersch, MD 003216533834 dr.lode.vermeersch@skynet.be | |
| Principal Investigator: Lode Vermeersch, MD | |
| Erik Schreurs | Terminated |
| Tremelo, Brabant, Belgium, 3120 | |
| Luc De Munck | Recruiting |
| Vilvoorde, Brabant, Belgium, 1800 | |
| Contact: Luc De Munck, MD 003222521183 lucdemunck@telenet.be | |
| Principal Investigator: Luc De Munck, MD | |
| Patrice Lechien | Recruiting |
| Braine-le-Comte, Hainaut, Belgium, 7090 | |
| Contact: Patrice Lechien, MD 003267552765 patrice.lechien@docs.be | |
| Principal Investigator: Patrice Lechien, MD | |
| Charles Corbisier | Recruiting |
| Ecaussinnes, Hainaut, Belgium, 7190 | |
| Contact: Charles Corbisier, MD 003267444197 chcorbisier@skynet.be | |
| Principal Investigator: Charles Corbisier, MD | |
| Elise De Meulemeester | Recruiting |
| Gozée, Hainaut, Belgium, 6534 | |
| Contact: Elise De Meulemeester, MD 003271511942 demeu@brutele.be | |
| Principal Investigator: Elise De Meulemeester, MD | |
| Magali Trefois | Recruiting |
| Gozée, Hainaut, Belgium, 6534 | |
| Contact: Magali Trefois, MD 003271511942 magali.trefois@belgacom.net | |
| Principal Investigator: Magali Trefois, MD | |
| Philippe Jacques | Recruiting |
| Ham-sur-Heure Nalinnes, Hainaut, Belgium, 6120 | |
| Contact: Philippe Jacques, MD 003271215265 philippe.jacques@docs.be | |
| Principal Investigator: Philippe Jacques, MD | |
| Aubry Robert | Recruiting |
| Ham-sur-Heure Nalinnes, Hainaut, Belgium, 6120 | |
| Contact: Aubry Robert, MD 003271215265 aubryrobert@gmail.com | |
| Principal Investigator: Aubry Robert, MD | |
| Michel Grégoire | Recruiting |
| Pont-à-Celles, Hainaut, Belgium, 6230 | |
| Contact: Michel Grégoire, MD 003271846344 tsf60040@scarlet.be | |
| Principal Investigator: Michel Grégoire, MD | |
| Etienne Demanet | Recruiting |
| Thuin, Hainaut, Belgium, 6530 | |
| Contact: Etienne Demanet, MD 003271592728 e.demanet@scarlet.be | |
| Principal Investigator: Etienne Demanet, MD | |
| Maria Buscemi | Recruiting |
| Thuin, Hainaut, Belgium, 6530 | |
| Contact: Maria Buscemi, MD 003271592728 buscemima@gmail.com | |
| Principal Investigator: Maria Buscemi, MD | |
| Etienne Plees | Terminated |
| Beringen, Limburg, Belgium, 3580 | |
| Nicole Olaerts | Recruiting |
| Ham, Limburg, Belgium, 3945 | |
| Contact: Nicole Olaerts, MD 003211393510 dr.olaerts@skynet.be | |
| Principal Investigator: Nicole Olaerts, MD | |
| Paul Beke | Recruiting |
| Leopoldsburg, Limburg, Belgium, 3970 | |
| Contact: Paul Beke, MD 003211346306 paul.beke@scarlet.be | |
| Principal Investigator: Paul Beke, MD | |
| Steven Windmolders | Recruiting |
| Overpelt, Limburg, Belgium, 3900 | |
| Contact: Steven Windmolders, MD 003211543683 steven.windmolders@telenet.be | |
| Principal Investigator: Steven Windmolders, MD | |
| Jos Weckx | Recruiting |
| Paal, Limburg, Belgium, 3583 | |
| Contact: Jos Weckx, MD 003211423710 josweckx@skynet.be | |
| Principal Investigator: Jos Weckx, MD | |
| Jan Behets | Not yet recruiting |
| Paal, Limburg, Belgium, 3583 | |
| Contact: Jan Behets, MD 003211422009 jan.behets@deberm.be | |
| Principal Investigator: Jan Behets, MD | |
| Herman Van Den Broeck | Recruiting |
| Tessenderlo, Limburg, Belgium, 3980 | |
| Contact: Herman Van Den Broeck, MD 003213321424 h.vandenbroeck@telenet.be | |
| Principal Investigator: Herman Van Den Broeck, MD | |
| Yvan Calozet | Recruiting |
| Gribomont, Luxembourg, Belgium, 6887 | |
| Contact: Yvan Calozet, MD 003261415515 calozet.yvan@skynet.be | |
| Principal Investigator: Yvan Calozet, MD | |
| Pierre-Henri Arnould | Recruiting |
| Libramont-Chevigny, Luxembourg, Belgium, 6800 | |
| Contact: Pierre-Henri Arnould, MD 003261230660 ph.arnould@skynet.be | |
| Principal Investigator: Pierre-Henri Arnould, MD | |
| Guy Van Damme | Recruiting |
| Heusden, Oost Vlaanderen, Belgium, 9070 | |
| Contact: Guy Van Damme, MD 003292319913 codam@village.uunet.be | |
| Principal Investigator: Guy Van Damme, MD | |
Sponsors and Collaborators
Theranor s.p.r.l
Investigators
| Principal Investigator: | Stéphane Heijmans, MD | RESEARCHLINK sprl |
| Study Director: | Luc Moriau, PhD | ECSOR sa/nv |
| Study Chair: | Michel Thiry, PhD | THERANOR sprl |
More Information
No publications provided
| Responsible Party: | Theranor s.p.r.l |
| ClinicalTrials.gov Identifier: | NCT01651715 History of Changes |
| Other Study ID Numbers: | ESTUAR001 |
| Study First Received: | July 25, 2012 |
| Last Updated: | May 2, 2013 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
Additional relevant MeSH terms:
|
Common Cold Respiratory Tract Infections Picornaviridae Infections RNA Virus Infections Virus Diseases Respiratory Tract Diseases |
Infection Antibodies Immunoglobulins Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013