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Efficacy and Safety Study of Reslizumab to Treat Eosinophilic Esophagitis in Subjects Aged 5 to 18 Years

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: NCT00538434
Recruitment Status : Completed
First Posted : October 2, 2007
Results First Posted : September 2, 2016
Last Update Posted : September 2, 2016
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Ception Therapeutics )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Eosinophilic Esophagitis
Interventions Biological: Reslizumab
Other: Saline
Enrollment 227
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Reslizumab 1 mg/kg Reslizumab 2 mg/kg Reslizumab 3 mg/kg Placebo
Hide Arm/Group Description reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
Period Title: Overall Study
Started 56 57 57 57
Intent-to-treat (ITT) Population 55 [1] 57 57 57
Completed 47 [2] 46 [2] 50 [2] 51 [2]
Not Completed 9 11 7 6
[1]
1 participant was randomized but not treated
[2]
Completed all scheduled study visits
Arm/Group Title Reslizumab 1 mg/kg Reslizumab 2 mg/kg Reslizumab 3 mg/kg Placebo Total
Hide Arm/Group Description reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles Total of all reporting groups
Overall Number of Baseline Participants 55 57 57 57 226
Hide Baseline Analysis Population Description
ITT population: all randomized participants who received any amount of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 55 participants 57 participants 57 participants 57 participants 226 participants
12.3  (3.83) 11.8  (3.82) 11.5  (4.04) 11.9  (4.17) 11.9  (3.95)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 55 participants 57 participants 57 participants 57 participants 226 participants
5 to < 12 years 21 26 27 25 99
12 to < 19 years 34 31 30 32 127
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 57 participants 57 participants 57 participants 226 participants
Female
14
  25.5%
15
  26.3%
12
  21.1%
13
  22.8%
54
  23.9%
Male
41
  74.5%
42
  73.7%
45
  78.9%
44
  77.2%
172
  76.1%
1.Primary Outcome
Title Mean Percent Change From Baseline to End of Treatment in Peak Esophageal Eosinophil (EE) Levels
Hide Description Participants underwent esophagogastroduodenoscopy (EGD) with biopsy (2 biopsies each at proximal and distal esophageal locations, plus any inflamed or abnormal areas) per standard clinical practice for the determination of esophageal eosinophils.
Time Frame Baseline, End of Treatment (up to 15 weeks [+/- 4 days])
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all randomized participants who received any amount of study drug.
Arm/Group Title Reslizumab 1 mg/kg Reslizumab 2 mg/kg Reslizumab 3 mg/kg Placebo
Hide Arm/Group Description:
reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
Overall Number of Participants Analyzed 55 57 57 57
Mean (Standard Deviation)
Unit of Measure: percentage change in eosinophils/hpf
-37.60  (70.86) -58.27  (35.45) -56.46  (34.82) 11.50  (91.42)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reslizumab 1 mg/kg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method ANCOVA
Comments adjustment for stratification factor and for variable at Baseline
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -52.78
Confidence Interval (2-Sided) 95%
-75.24 to -30.32
Parameter Dispersion
Type: Standard Error of the mean
Value: 11.40
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Reslizumab 2 mg/kg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method ANCOVA
Comments adjustment for stratification factor and for variable at Baseline
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -73.03
Confidence Interval (2-Sided) 95%
-95.28 to -50.78
Parameter Dispersion
Type: Standard Error of the mean
Value: 11.29
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Reslizumab 3 mg/kg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method ANCOVA
Comments adjustment for stratification factor and for variable at Baseline
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -64.69
Confidence Interval (2-Sided) 95%
-86.93 to -42.45
Parameter Dispersion
Type: Standard Error of the mean
Value: 11.28
Estimation Comments [Not Specified]
2.Primary Outcome
Title Mean Change From Baseline in Physician's Esophageal Eosinophil (EE) Global Assessment At The End-of-Treatment Visit (or at Early Withdrawal)
Hide Description

The investigator completed the Physician’s EE Global Assessment based upon the participant’s reporting of symptoms, weight, dietary status, and overall well-being. The assessment rated severity on a five-point scale (0=none to 4=very severe), taking into account physical findings, vital signs, the Subject’s Predominant EE Symptom Assessment, the subject’s diary data, and dietary questions. The Subject's Predominant EE Symptom was the EE symptom (vomiting/regurgitation, abdominal/chest pain, or dysphagia) that had the greatest negative impact on the subject based on patient diary data as of the baseline visit.

The full range for change from baseline values is -4 (very severe at baseline, none at end of study) to 4 (none at baseline, severe at end of study). Negative change from baseline scores in the Physician's EE Global Assessment indicate improvement in EE status.

Time Frame Baseline (Day 1, pre-treatment), End of Treatment (Week 15, 3 weeks [± 4 days] after the last dose of study drug, or at early withdrawal)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all randomized participants who received any amount of study drug with both a baseline and an End of Treatment assessment.
Arm/Group Title Reslizumab 1 mg/kg Reslizumab 2 mg/kg Reslizumab 3 mg/kg Placebo
Hide Arm/Group Description:
reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
Overall Number of Participants Analyzed 55 57 57 57
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.85 [1]   (NA) -1.02 [1]   (NA) -1.12 [1]   (NA) -1.14 [1]   (NA)
[1]
Study documentation from an acquired company does not contain the measure of dispersion.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reslizumab 1 mg/kg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0313
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Reslizumab 2 mg/kg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5793
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Reslizumab 3 mg/kg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4905
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
3.Secondary Outcome
Title Mean Change From Baseline to End of Treatment in EE Predominant Symptom Assessment
Hide Description Participants rated the severity of each EE symptom (vomiting/regurgitation, abdominal/chest pain, and dysphagia) based on the previous week’s daily diary as none (=0), mild, moderate, severe, or very severe (=4). The predominant symptom was selected at the baseline visit and remained the same throughout the trial. The predominant symptom was defined as the EE symptom that had the greatest negative impact on the participant. The full range for change from baseline values is -4 (very severe at baseline, none at end of study) to 4 (none at baseline, severe at end of study). Negative change from baseline scores in the Patient's EE Predominant Symptom Assessment indicate improvement in the selected symptom.
Time Frame Baseline (Day 1, pre-treatment), End of Treatment (Week 15, 3 weeks [± 4 days] after the last dose of study drug, or at early withdrawal)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all randomized participants who received any amount of study drug with both a baseline and an End of Treatment assessment.
Arm/Group Title Reslizumab 1 mg/kg Reslizumab 2 mg/kg Reslizumab 3 mg/kg Placebo
Hide Arm/Group Description:
reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
Overall Number of Participants Analyzed 54 56 57 55
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.94 [1]   (NA) -1.20 [1]   (NA) -1.28 [1]   (NA) -1.44 [1]   (NA)
[1]
Study documentation from an acquired company does not contain the measure of dispersion.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reslizumab 1 mg/kg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0062
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Reslizumab 2 mg/kg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0943
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Reslizumab 3 mg/kg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2955
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
4.Secondary Outcome
Title Mean Percent Change From Baseline to End of Treatment in the Child Health Questionnaire (CHQ)
Hide Description CHQ is a quality-of-life (QoL), observer-rated (the parent in this study) instrument designed to assess the general health and well-being of pediatric subjects aged 5 to 18 years. The instrument comprises 50 items that cover 14 unique physical and psychological concepts. Each item was scored separately following different scales and timeframes for response. Proprietary scoring algorithms are used. This outcome reports the two CHQ Summary Scores (Physical Summary Score and the Psychosocial Summary Scores) which are indexed to a 0 (poorest quality of life) to 100 (best quality of life) scores. The two summary scores are subsequently combined (via proprietary algorithm) to create the Global Health Summary Score (also on a 0-100 scale). Percent change from baseline values range from 100% (poorest QoL at baseline, best QoL at end of treatment) to -100% (best QoL at baseline, poorest QoL at end of treatment). Higher percent change from baseline values indicate improved QoL.
Time Frame Baseline, End of Treatment (up to 15 weeks +/- 4 days)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all randomized participants who received any amount of study drug with both a baseline and an End of Treatment assessment; n=number of participants with a response in the given category.
Arm/Group Title Reslizumab 1 mg/kg Reslizumab 2 mg/kg Reslizumab 3 mg/kg Placebo
Hide Arm/Group Description:
reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
reslizumab 2 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
Overall Number of Participants Analyzed 55 57 57 57
Mean (Standard Deviation)
Unit of Measure: percentage change in score
Physical Summary Score; n=49, 52, 53, 57 11.2 [1]   (NA) 18.6 [1]   (NA) 18.5 [1]   (NA) 11.8 [1]   (NA)
Psychosocial Summary Score; n=51, 52, 53, 55 5.0 [1]   (NA) 12.2 [1]   (NA) 14.1 [1]   (NA) 10.1 [1]   (NA)
Global Health Summary Score; n=50, 54, 54, 55 10.2 [1]   (NA) 15.5 [1]   (NA) 10.3 [1]   (NA) 9.7 [1]   (NA)
[1]
Study documentation from an acquired company does not contain the measure of dispersion.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reslizumab 1 mg/kg, Placebo
Comments Physical Summary Score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4644
Comments Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -4.75
Confidence Interval (2-Sided) 95%
-17.53 to 8.03
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.48
Estimation Comments Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Reslizumab 2 mg/kg, Placebo
Comments Physical Summary Score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8196
Comments Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.47
Confidence Interval (2-Sided) 95%
-14.17 to 11.23
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.44
Estimation Comments Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Reslizumab 3 mg/kg, Placebo
Comments Physical Summary Score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8306
Comments Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 1.36
Confidence Interval (2-Sided) 95%
-11.19 to 13.91
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.36
Estimation Comments Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Reslizumab 1 mg/kg, Placebo
Comments Psychosocial Summary Score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1459
Comments Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -6.38
Confidence Interval (2-Sided) 95%
-15.01 to 2.24
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.37
Estimation Comments Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Reslizumab 2 mg/kg, Placebo
Comments Psychosocial Summary Score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4375
Comments Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -3.41
Confidence Interval (2-Sided) 95%
-12.05 to 5.23
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.38
Estimation Comments Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Reslizumab 3 mg/kg, Placebo
Comments Psychosocial Summary Score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9217
Comments Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.43
Confidence Interval (2-Sided) 95%
-9.00 to 8.15
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.35
Estimation Comments Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Reslizumab 1 mg/kg, Placebo
Comments Global Health Score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8412
Comments Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.57
Confidence Interval (2-Sided) 95%
-16.98 to 13.85
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.82
Estimation Comments Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Reslizumab 2 mg/kg, Placebo
Comments Global Health Score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4794
Comments Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -5.54
Confidence Interval (2-Sided) 95%
-20.94 to 9.87
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.81
Estimation Comments Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Reslizumab 3 mg/kg, Placebo
Comments Global Health Score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8906
Comments Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.06
Confidence Interval (2-Sided) 95%
-16.16 to 14.06
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.66
Estimation Comments Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.
Time Frame Baseline through Safety Follow-up (Week 16)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Reslizumab 1 mg/kg Reslizumab 2 mg/kg Reslizumab 3 mg/kg Placebo
Hide Arm/Group Description reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
All-Cause Mortality
Reslizumab 1 mg/kg Reslizumab 2 mg/kg Reslizumab 3 mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Reslizumab 1 mg/kg Reslizumab 2 mg/kg Reslizumab 3 mg/kg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/55 (1.82%)      1/57 (1.75%)      1/57 (1.75%)      2/57 (3.51%)    
Gastrointestinal disorders         
ABDOMINAL PAIN  1  0/55 (0.00%)  0 0/57 (0.00%)  0 0/57 (0.00%)  0 1/57 (1.75%)  1
GASTROINTESTINAL INFLAMMATION  1  1/55 (1.82%)  1 0/57 (0.00%)  0 0/57 (0.00%)  0 0/57 (0.00%)  0
Immune system disorders         
ANAPHYLACTIC REACTION  1  0/55 (0.00%)  0 0/57 (0.00%)  0 0/57 (0.00%)  0 1/57 (1.75%)  1
Infections and infestations         
GASTROENTERITIS VIRAL  1  0/55 (0.00%)  0 1/57 (1.75%)  1 0/57 (0.00%)  0 0/57 (0.00%)  0
Nervous system disorders         
SYNCOPE  1  0/55 (0.00%)  0 0/57 (0.00%)  0 0/57 (0.00%)  0 1/57 (1.75%)  1
Respiratory, thoracic and mediastinal disorders         
RESPIRATORY DISTRESS  1  0/55 (0.00%)  0 0/57 (0.00%)  0 1/57 (1.75%)  1 0/57 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Reslizumab 1 mg/kg Reslizumab 2 mg/kg Reslizumab 3 mg/kg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   38/55 (69.09%)      29/57 (50.88%)      39/57 (68.42%)      40/57 (70.18%)    
Gastrointestinal disorders         
ABDOMINAL PAIN  1  6/55 (10.91%)  7 0/57 (0.00%)  0 3/57 (5.26%)  3 2/57 (3.51%)  2
ABDOMINAL PAIN UPPER  1  4/55 (7.27%)  4 2/57 (3.51%)  2 4/57 (7.02%)  5 5/57 (8.77%)  8
DIARRHOEA  1  4/55 (7.27%)  4 3/57 (5.26%)  3 0/57 (0.00%)  0 5/57 (8.77%)  8
NAUSEA  1  6/55 (10.91%)  6 2/57 (3.51%)  2 4/57 (7.02%)  4 3/57 (5.26%)  3
VOMITING  1  2/55 (3.64%)  2 2/57 (3.51%)  3 2/57 (3.51%)  4 5/57 (8.77%)  5
General disorders         
CHEST PAIN  1  1/55 (1.82%)  1 1/57 (1.75%)  1 1/57 (1.75%)  1 3/57 (5.26%)  3
FATIGUE  1  5/55 (9.09%)  7 2/57 (3.51%)  6 3/57 (5.26%)  6 1/57 (1.75%)  1
PYREXIA  1  4/55 (7.27%)  5 2/57 (3.51%)  2 3/57 (5.26%)  4 6/57 (10.53%)  8
Infections and infestations         
GASTROENTERITIS VIRAL  1  1/55 (1.82%)  1 3/57 (5.26%)  3 1/57 (1.75%)  1 0/57 (0.00%)  0
INFLUENZA  1  2/55 (3.64%)  2 0/57 (0.00%)  0 4/57 (7.02%)  4 1/57 (1.75%)  1
NASOPHARYNGITIS  1  3/55 (5.45%)  3 2/57 (3.51%)  2 1/57 (1.75%)  1 7/57 (12.28%)  8
OTITIS MEDIA  1  0/55 (0.00%)  0 3/57 (5.26%)  3 1/57 (1.75%)  1 0/57 (0.00%)  0
PHARYNGITIS STREPTOCOCCAL  1  3/55 (5.45%)  3 1/57 (1.75%)  1 0/57 (0.00%)  0 3/57 (5.26%)  3
SINUSITIS  1  5/55 (9.09%)  5 1/57 (1.75%)  1 5/57 (8.77%)  6 4/57 (7.02%)  4
UPPER RESPIRATORY TRACT INFECTION  1  5/55 (9.09%)  5 4/57 (7.02%)  4 6/57 (10.53%)  6 5/57 (8.77%)  6
VIRAL INFECTION  1  3/55 (5.45%)  3 3/57 (5.26%)  3 1/57 (1.75%)  1 0/57 (0.00%)  0
Investigations         
PROTEIN URINE  1  0/55 (0.00%)  0 0/57 (0.00%)  0 0/57 (0.00%)  0 3/57 (5.26%)  3
RED BLOOD CELLS URINE POSITIVE  1  3/55 (5.45%)  3 0/57 (0.00%)  0 0/57 (0.00%)  0 2/57 (3.51%)  2
URINARY CASTS  1  2/55 (3.64%)  2 0/57 (0.00%)  0 0/57 (0.00%)  0 4/57 (7.02%)  4
URINE OXALATE INCREASED  1  3/55 (5.45%)  4 0/57 (0.00%)  0 0/57 (0.00%)  0 1/57 (1.75%)  1
WHITE BLOOD CELLS URINE POSITIVE  1  4/55 (7.27%)  7 0/57 (0.00%)  0 0/57 (0.00%)  0 1/57 (1.75%)  1
Musculoskeletal and connective tissue disorders         
ARTHRALGIA  1  5/55 (9.09%)  6 1/57 (1.75%)  1 0/57 (0.00%)  0 0/57 (0.00%)  0
Nervous system disorders         
DIZZINESS  1  2/55 (3.64%)  3 1/57 (1.75%)  1 6/57 (10.53%)  7 1/57 (1.75%)  2
HEADACHE  1  8/55 (14.55%)  9 6/57 (10.53%)  7 12/57 (21.05%)  15 7/57 (12.28%)  7
Respiratory, thoracic and mediastinal disorders         
COUGH  1  5/55 (9.09%)  5 6/57 (10.53%)  7 6/57 (10.53%)  7 6/57 (10.53%)  6
NASAL CONGESTION  1  7/55 (12.73%)  9 3/57 (5.26%)  3 4/57 (7.02%)  4 8/57 (14.04%)  9
PHARYNGOLARYNGEAL PAIN  1  6/55 (10.91%)  6 3/57 (5.26%)  3 4/57 (7.02%)  5 9/57 (15.79%)  12
Skin and subcutaneous tissue disorders         
ECZEMA  1  0/55 (0.00%)  0 4/57 (7.02%)  4 0/57 (0.00%)  0 1/57 (1.75%)  1
RASH  1  4/55 (7.27%)  5 1/57 (1.75%)  1 0/57 (0.00%)  0 4/57 (7.02%)  5
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
Results Point of Contact
Name/Title: Director, Clinical Research
Organization: Teva Branded Pharmaceutical Products, R&D Inc.
Phone: 215-591-3000
Responsible Party: Teva Pharmaceutical Industries ( Ception Therapeutics )
ClinicalTrials.gov Identifier: NCT00538434     History of Changes
Other Study ID Numbers: Res-05-0002
First Submitted: October 1, 2007
First Posted: October 2, 2007
Results First Submitted: March 23, 2016
Results First Posted: September 2, 2016
Last Update Posted: September 2, 2016