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Trial record 48 of 1269 for:    IFNA2

Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00895947
Recruitment Status : Completed
First Posted : May 8, 2009
Results First Posted : January 13, 2011
Last Update Posted : September 16, 2011
Sponsor:
Collaborator:
Department of Health, Western Australia
Information provided by (Responsible Party):
Amarillo Biosciences, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Upper Respiratory Tract Infections
Interventions Drug: interferon-alpha
Other: placebo
Enrollment 200
Recruitment Details A total of 200 healthy volunteers were enrolled at the University of Western Australia in Perth between April 17 and July 31, 2009.
Pre-assignment Details Two of 200 randomized subjects (one in each group) decided not to begin study treatment after enrollment, so only 198 subjects were evaluable for response.
Arm/Group Title Interferon-alpha Placebo
Hide Arm/Group Description 150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose 200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
Period Title: Overall Study
Started 100 100
Completed 88 90
Not Completed 12 10
Reason Not Completed
Adverse Event             3             4
Lost to Follow-up             3             4
Protocol Violation             4             2
Withdrawal by Subject             2             0
Arm/Group Title Interferon-alpha Placebo Total
Hide Arm/Group Description 150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose 200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge Total of all reporting groups
Overall Number of Baseline Participants 100 100 200
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
95
  95.0%
91
  91.0%
186
  93.0%
>=65 years
5
   5.0%
9
   9.0%
14
   7.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants 100 participants 200 participants
45.0  (14.4) 47.3  (13.2) 46.2  (14.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
Female
70
  70.0%
66
  66.0%
136
  68.0%
Male
30
  30.0%
34
  34.0%
64
  32.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Australia Number Analyzed 100 participants 100 participants 200 participants
100 100 200
1.Primary Outcome
Title Frequency of Influenza-like Illness
Hide Description Number of subjects in each group meeting the definition of influenza-like illness during treatment (i.e. those subject reporting one or more moderate to severe cold/flu symptoms during the treatment period).
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, defined as all randomized subjects who took at least one dose of study drug
Arm/Group Title Interferon-alpha Placebo
Hide Arm/Group Description:
150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
Overall Number of Participants Analyzed 99 99
Measure Type: Number
Unit of Measure: participants
Overall 54 62
Age 50 and over 16 28
Age under 50 38 34
Seasonal flu vaccine, yes 16 36
Seasonal flu vaccine, no 38 26
Gender, Male 11 22
Gender, Female 43 40
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Interferon-alpha, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments Overall comparison of treatment groups for incidence of ILI
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Interferon-alpha, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments Comparision of ILI incidence in subjects age 50 and older at baseline.
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Interferon-alpha, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.32
Comments Comparison of ILI in subjects age < 50 at baseline
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Interferon-alpha, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments Comparison of ILI incidence in subjects vaccinated against seasonal influenza prior to enrollment.
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Interferon-alpha, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments Comparison of ILI incidence in subjects not vaccinated against seasonal influenza prior to enrollment
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Interferon-alpha, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments Comparison of ILI incidence in male subjects
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Interferon-alpha, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments Comparison of ILI incidence in female subjects
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Symptom Incidence/Severity
Hide Description Number of subjects in each group reporting 13 different cold/flu symptoms assessed weekly
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Interferon-alpha Placebo
Hide Arm/Group Description:
150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
Overall Number of Participants Analyzed 99 99
Measure Type: Number
Unit of Measure: participants
any cold/flu symptoms 86 92
moderate to severe feverishness 12 24
moderate to severe head congestion 23 36
moderate to severe sore throat 27 39
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Interferon-alpha, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments Proportion of subjects reporting any cold/flu symptoms during treatment
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Interferon-alpha, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments Proportion of subjects reporting moderate to severe feverishness
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Interferon-alpha, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments Proportion of subjects reporting moderate to severe head congestion
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Interferon-alpha, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments Proportion of subjects reporting moderate to severe sore throat
Method Chi-squared
Comments [Not Specified]
3.Secondary Outcome
Title Impact of Cold/Flu Symptoms
Hide Description Number of subjects in each group reporting that cold/flu symptoms impacted the following 9 measures of daily life: ability to (1) think clearly, (2) sleep well, (3) breathe easily, (4) walk, climb stairs and exercise, (5) perform daily tasks, (6) work outside the home, (7) work inside the home, (8) interact with others, and (9) live personal life.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Interferon-alpha Placebo
Hide Arm/Group Description:
150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
Overall Number of Participants Analyzed 99 99
Measure Type: Number
Unit of Measure: participants
think clearly 53 59
sleep well 54 64
breathe easily 58 61
walk, climb stairs and exercise 44 49
perform daily activities 46 54
work outside the home 43 51
work inside the home 42 51
interact with others 41 50
live personal life 44 51
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Interferon-alpha, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.39
Comments Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to think clearly
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Interferon-alpha, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to sleep well
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Interferon-alpha, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.66
Comments Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to breathe easily
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Interferon-alpha, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.48
Comments Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to walk, climb stairs and exercise
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Interferon-alpha, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to perform daily activities
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Interferon-alpha, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to work outside the home
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Interferon-alpha, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.20
Comments Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to work inside the home
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Interferon-alpha, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.20
Comments Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to interact with others
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Interferon-alpha, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.32
Comments Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to live personal life
Method Chi-squared
Comments [Not Specified]
4.Secondary Outcome
Title Negative Events Related to Cold/Flu Symptoms
Hide Description Number of subjects in each group reporting one or days of occurrence of the following 6 negative events: (1) felt sick, (2) missed work, (3) went to the doctor, (4) went to the pharmacy, (5) took cold/flu medication, and (6) skipped a planned activity
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Interferon-alpha Placebo
Hide Arm/Group Description:
150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
Overall Number of Participants Analyzed 99 99
Measure Type: Number
Unit of Measure: participants
felt sick 62 65
missed work 32 33
visited the doctor 16 16
visited the pharmacy 34 30
took cold/flu medication 57 65
skipped a planned activity 46 45
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Interferon-alpha, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.66
Comments Proportion of subjects in each group reporting one or more days they felt sick
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Interferon-alpha, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.88
Comments Proportion of subjects in each group reporting one or more days they missed work
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Interferon-alpha, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments Proportion of subjects in each group reporting one or more days they visited the doctor
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Interferon-alpha, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.54
Comments Proportion of subjects in each group reporting one or more days they visited the pharmacy
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Interferon-alpha, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments Proportion of subjects in each group reporting one or more days they took cold/flu medication
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Interferon-alpha, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.89
Comments Proportion of subjects in each group reporting one or more days they skipped a planned activity
Method Chi-squared
Comments [Not Specified]
5.Secondary Outcome
Title Incidence/Severity of Viral Respiratory Infections
Hide Description Number of subjects in each group with a confirmed viral respiratory infection and the proportion of subjects reporting a mild vs. moderate to severe infection
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Interferon-alpha Placebo
Hide Arm/Group Description:
150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
Overall Number of Participants Analyzed 99 99
Measure Type: Number
Unit of Measure: participants
incidence of viral respiratory infection 20 23
moderate/severe viral respiratory infection 5 16
moderate/severe influenza infection 1 4
moderate/severe non-influenza infection 4 11
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Interferon-alpha, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.61
Comments Proportion of subjects in each group with a confirmed viral respiratory infection
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Interferon-alpha, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments Proportion of subjects in each group with a moderate/severe viral respiratory infection
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Interferon-alpha, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments Proportion of subjects in each group with a moderate/severe influenza infection
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Interferon-alpha, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments Proportion of subjects in each group with a moderate/severe viral respiratory infection other than influenza
Method Chi-squared
Comments [Not Specified]
6.Post-Hoc Outcome
Title Acute Respiratory Illness
Hide Description Number of subjects in each group meeting definition of acute respiratory illness (ARI), defined as 2 or more cold/flu symptoms reported in the same week. Further defined as "febrile" or "afebrile" depending on whether the subject reported the symptom of "feverishness."
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Interferon-alpha Placebo
Hide Arm/Group Description:
150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
Overall Number of Participants Analyzed 99 99
Measure Type: Number
Unit of Measure: participants
all acute respiratory illness (ARI) 83 86
moderate/severe ARI 41 54
moderate/severe febrile ARI 12 24
moderate/severe afebrile ARI 35 31
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Interferon-alpha, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.54
Comments Proportion of subjects meeting the definition of acute respiratory illness during treatment
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Interferon-alpha, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments Proportion of subjects meeting with moderate/severe acute respiratory illness during treatment
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Interferon-alpha, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments Proportion of subjects with moderate/severe febrile acute respiratory illness during treatment
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Interferon-alpha, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.60
Comments Proportion of subjects with moderate/severe afebrile acute respiratory illness during treatment
Method Chi-squared
Comments [Not Specified]
Time Frame 16 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Interferon-alpha Placebo
Hide Arm/Group Description 150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose 200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
All-Cause Mortality
Interferon-alpha Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Interferon-alpha Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/99 (1.01%)      1/99 (1.01%)    
Surgical and medical procedures     
appendectomy * [1]  0/99 (0.00%)  0 1/99 (1.01%)  1
hemorroidectomy * [2]  1/99 (1.01%)  1 0/99 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
subject underwent an emergency appendectomy judged by the attending investigator to be unrelated to study medication
[2]
subject underwent an emergency hemorroidectomy judged by the attending investigator to be unrelated to study medication
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Interferon-alpha Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/99 (30.30%)      33/99 (33.33%)    
Gastrointestinal disorders     
diarrhea *  14/99 (14.14%)  20 9/99 (9.09%)  12
nausea *  5/99 (5.05%)  5 6/99 (6.06%)  7
General disorders     
fatigue *  4/99 (4.04%)  5 8/99 (8.08%)  9
Musculoskeletal and connective tissue disorders     
back pain *  4/99 (4.04%)  4 6/99 (6.06%)  8
Nervous system disorders     
headache *  11/99 (11.11%)  20 10/99 (10.10%)  14
migraine *  4/99 (4.04%)  4 5/99 (5.05%)  10
Respiratory, thoracic and mediastinal disorders     
hay fever *  6/99 (6.06%)  8 13/99 (13.13%)  17
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Martin J. Cummins
Organization: Amarillo Biosciences, Inc.
Phone: 806-376-1741 ext 14
Responsible Party: Amarillo Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT00895947     History of Changes
Other Study ID Numbers: 2008-113
First Submitted: May 6, 2009
First Posted: May 8, 2009
Results First Submitted: November 16, 2010
Results First Posted: January 13, 2011
Last Update Posted: September 16, 2011