Ignite Creation Date:
2024-05-06 @ 12:46 AM
Last Modification Date:
2024-10-26 @ 10:54 AM
Study NCT ID:
NCT01651715
Status:
COMPLETED
Last Update Posted:
2013-08-07
First Post:
2012-07-25
Brief Title:
Efficacy and Safety Study of Homeopathic Oral Antibodies to Treat Viral Upper Respiratory Tract Infections
Sponsor:
Theranor sprl
Organization:
Theranor sprl
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESTUAR
Brief Summary:
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
Detailed Description:
TAO1 is an investigational medicinal product containing homoeopathic 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
The validity of the TAO1 development approach was addressed in a proof of concept study of efficacy in a non-lethal influenza infection in mice In this blinded study TAO1 was given in drinking water for 5 days before and 10 days after viral challenge The statistical analysis of preclinical data was carried out by using the Mann-Whitney non-parametric test 2-tailed The clinical disease duration was significantly reduced from 60 525 25th percentile70 75th percentile days to 50 5050 days p000037 as well as the overall disease severity that was lowered from 80 70100 points to 60 5075 points p000032
Given the high homoeopathic dilution the active substance in the finished product lies beyond sensitivity of existing analytical assays TAO1 is therefore not amenable to pharmacokinetics studies
There are currently no data on clinical efficacy of TAO1 in common cold obtained in double-blind placebo-controlled clinical trials Based on the efficacy in the animal model the expected magnitude of effect of TAO1 in humans is a reduction of common cold duration by 2-3 days provided that the treatment is started early after the onset of the symptoms
Primary objective
To evaluate the efficacy of TAO1 in reducing the severity of symptoms of common cold in otherwise healthy adults
Secondary objectives
To evaluate the efficacy of TAO1 in reducing the duration of common cold To evaluate the impact of TAO1 on health-related Quality of Life functional impairment in patients with common cold
To evaluate the safety of TAO1
Experimental design Double-blind parallel-group randomised multicentre placebo-controlled study
Treatment allocation Balanced allocation between TAO1 and placebo 11
At Visit 1 the medications questionnaires and diary cards will be dispensed to patients who have signed informed consent Upon contracting a common cold they will start the treatment immediately and take contact with the doctor by phone within 36 hours On Day 2-3 after the onset of disease they will visit the doctor Visit 2 to confirm the diagnosis The doctor will check if questionnaires are filled in correctly On the 10-14th day at the latest after start of treatment Visit 3 is planned to pick up questionnaires evaluate safety disease complications and treatment compliance
Treatment group TAO1 tablets to be dissolved in the mouth not to be swallowed should be taken at least 10 minutes apart from meals andor smoking
Day 1 3 tablets to be taken over the first 2 hours of treatment then 3 tablets over the rest of Day 1
Days 2-3 5 tabletsday intakes distributed evenly over the daytime
Days 4-7 3 tabletsday intakes distributed evenly over the daytime
Control Placebo tablets same dosage regimen as for TAO1
Concomitant medications Only oral analgesicsantipyretics such as paracetamol or ibuprofen will be allowed in case of fever or headache Each intake of such medications will be registered in the patients diary
Severity and duration of self-reported symptoms evaluated daily by the validated Wisconsin Upper Respiratory Symptom Survey short version WURSS-21
Evaluation of safety adverse events AEs and serious adverse events SAEs coded using the Medical Dictionary for Regulatory Activities MedDRA assessed according to their frequency severity outcome and relationship to the study drug
Data collection Paper Case Report Form CRF
Duration of treatment 7 days
Duration of study maximum 10 months
Number of Investigators about 35 investigators General Practitioners
Type of study Phase II self-contained study
Number of patients 240 120 treated with TAO1 and 120 treated with placebo
Sample size justification A sample size of 115 in each group will have 80 power to detect a difference in mean AUCs of 103 a difference of 30 between a Placebo AUC mean of 310 and a TAO1 AUC mean of 207 assuming that the common standard deviation is 277 using a two group t-test with a 0050 two-sided significance level
The validity of the TAO1 development approach was addressed in a proof of concept study of efficacy in a non-lethal influenza infection in mice In this blinded study TAO1 was given in drinking water for 5 days before and 10 days after viral challenge The statistical analysis of preclinical data was carried out by using the Mann-Whitney non-parametric test 2-tailed The clinical disease duration was significantly reduced from 60 525 25th percentile70 75th percentile days to 50 5050 days p000037 as well as the overall disease severity that was lowered from 80 70100 points to 60 5075 points p000032
Given the high homoeopathic dilution the active substance in the finished product lies beyond sensitivity of existing analytical assays TAO1 is therefore not amenable to pharmacokinetics studies
There are currently no data on clinical efficacy of TAO1 in common cold obtained in double-blind placebo-controlled clinical trials Based on the efficacy in the animal model the expected magnitude of effect of TAO1 in humans is a reduction of common cold duration by 2-3 days provided that the treatment is started early after the onset of the symptoms
Primary objective
To evaluate the efficacy of TAO1 in reducing the severity of symptoms of common cold in otherwise healthy adults
Secondary objectives
To evaluate the efficacy of TAO1 in reducing the duration of common cold To evaluate the impact of TAO1 on health-related Quality of Life functional impairment in patients with common cold
To evaluate the safety of TAO1
Experimental design Double-blind parallel-group randomised multicentre placebo-controlled study
Treatment allocation Balanced allocation between TAO1 and placebo 11
At Visit 1 the medications questionnaires and diary cards will be dispensed to patients who have signed informed consent Upon contracting a common cold they will start the treatment immediately and take contact with the doctor by phone within 36 hours On Day 2-3 after the onset of disease they will visit the doctor Visit 2 to confirm the diagnosis The doctor will check if questionnaires are filled in correctly On the 10-14th day at the latest after start of treatment Visit 3 is planned to pick up questionnaires evaluate safety disease complications and treatment compliance
Treatment group TAO1 tablets to be dissolved in the mouth not to be swallowed should be taken at least 10 minutes apart from meals andor smoking
Day 1 3 tablets to be taken over the first 2 hours of treatment then 3 tablets over the rest of Day 1
Days 2-3 5 tabletsday intakes distributed evenly over the daytime
Days 4-7 3 tabletsday intakes distributed evenly over the daytime
Control Placebo tablets same dosage regimen as for TAO1
Concomitant medications Only oral analgesicsantipyretics such as paracetamol or ibuprofen will be allowed in case of fever or headache Each intake of such medications will be registered in the patients diary
Severity and duration of self-reported symptoms evaluated daily by the validated Wisconsin Upper Respiratory Symptom Survey short version WURSS-21
Evaluation of safety adverse events AEs and serious adverse events SAEs coded using the Medical Dictionary for Regulatory Activities MedDRA assessed according to their frequency severity outcome and relationship to the study drug
Data collection Paper Case Report Form CRF
Duration of treatment 7 days
Duration of study maximum 10 months
Number of Investigators about 35 investigators General Practitioners
Type of study Phase II self-contained study
Number of patients 240 120 treated with TAO1 and 120 treated with placebo
Sample size justification A sample size of 115 in each group will have 80 power to detect a difference in mean AUCs of 103 a difference of 30 between a Placebo AUC mean of 310 and a TAO1 AUC mean of 207 assuming that the common standard deviation is 277 using a two group t-test with a 0050 two-sided significance level
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None