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Open-Label Extension Study of Reslizumab in Pediatric Subjects With Eosinophilic Esophagitis

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ClinicalTrials.gov Identifier: NCT00635089
Recruitment Status : Completed
First Posted : March 13, 2008
Results First Posted : March 23, 2017
Last Update Posted : March 23, 2017
Sponsor:
Collaborator:
Cephalon
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Ception Therapeutics )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Eosinophilic Esophagitis
Intervention Drug: reslizumab
Enrollment 190
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Open-Label Reslizumab
Hide Arm/Group Description Open-label reslizumab intravenous (IV) infusion at an initial dose of 1 mg/kg monthly
Period Title: Overall Study
Started 190
Completed >/= 16 Weeks of Study 181
Completed 112 [1]
Not Completed 78
Reason Not Completed
Adverse Event             7
Lack of Efficacy             28
Protocol Deviation             4
Lost to Follow-up             8
Not Specified             31
[1]
Participants who had not withdrawn at the time of study termination.
Arm/Group Title Open-Label Reslizumab
Hide Arm/Group Description Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
Overall Number of Baseline Participants 190
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 190 participants
12.1  (3.97)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 190 participants
5 to 11 years 81
12 to 19 years 109
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 190 participants
Female
42
  22.1%
Male
148
  77.9%
1.Primary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (AEs), Serious AEs, or Discontinuation Due to AEs
Hide Description An AE was defined as any adverse experience, including side effect, injury, toxicity, sensitivity reaction, intercurrent illness, or sudden death, whether or not it was considered related to the use of study drug. Treatment emergent adverse events were those that started any time after the administration of the first dose of study drug (at baseline of this study) and before the cessation of study drug. Serious adverse events that occurred any time after the administration of the first dose of study drug until 30 days after administration of the last dose of study drug were reported as treatment emergent serious adverse events.
Time Frame From start of study drug until end of treatment (mean [standard deviation {SD}] duration of treatment was 30.0 [5.89] months)
Hide Outcome Measure Data
Hide Analysis Population Description
Three additional participants experiences anaphylactic reactions that were upgraded to serious AEs after database lock. These 3 participants are not included in this table summary.
Arm/Group Title Open-Label Reslizumab
Hide Arm/Group Description:
Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
Overall Number of Participants Analyzed 190
Measure Type: Number
Unit of Measure: participants
Any AEs 177
Severe AEs 38
Treatment-related AEs 63
Deaths 0
Other Serious AEs 21
Withdrawn from study due to AEs 7
2.Primary Outcome
Title Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Hematology Value
Hide Description Hematology laboratory tests performed include: hemoglobin, hematocrit, red blood cell count, mean cell volume, mean cell hemoglobin, mean cell hemoglobin concentration, platelet count, white blood cell count, and differential count and percentage (polymorphonuclear leukocytes [neutrophils], lymphocytes, eosinophils, monocytes, basophils, platelets).
Time Frame From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with a postbaseline result for hematology tests.
Arm/Group Title Open-Label Reslizumab
Hide Arm/Group Description:
Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
Overall Number of Participants Analyzed 188
Measure Type: Number
Unit of Measure: participants
Hemoglobin </= 100 g/L 1
Hematocrit < 0.30 L/L 1
Leukocytes </= 3*10^9/L 7
Neutrophils </= 1*10^9/L 16
Platelets </= 75*10^9/L 3
3.Primary Outcome
Title Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Serum Chemistry Laboratory Test Results or Urinalysis Abnormality
Hide Description Serum chemistry laboratory tests performed include: calcium, phosphorus, magnesium, sodium, potassium, chloride, creatinine, glucose [nonfasting], blood urea nitrogen, total cholesterol, uric acid, alanine aminotransferase, aspartate aminotransferase, lactate dehydrogenase, gamma glutamyl transpeptidase, alkaline phosphatase, bicarbonate, creatine kinase, total protein, albumin, total bilirubin, direct bilirubin, indirect bilirubin. Urinalysis tests performed include: protein, glucose, ketones, bilirubin, urobilinogen, nitrite content, pH, specific gravity, white blood cells, microscopic (red blood cells, white blood cells, casts, crystals).
Time Frame From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open-Label Reslizumab
Hide Arm/Group Description:
Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
Overall Number of Participants Analyzed 190
Measure Type: Number
Unit of Measure: participants
Abnormal Serum Chemistry Laboratory Test Results 0
Urinalysis Abnormalities 0
4.Primary Outcome
Title Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Vital Signs Value
Hide Description Low systolic blood pressure: < 90 and decrease (↓) of 30 mm Hg from baseline (BL) (ages 5-18); high systolic blood pressure: > 160 and increase (↑) of 30 mm Hg from BL (age 5-12), > 130 and ↑ of 30 mm Hg from BL (age 13-18). Low diastolic blood pressure: < 45 and ↓ of 12 mm Hg from BL (age 5-12), < 55 and ↓ of 12 mm Hg from BL (age 13-18), < 50 and ↓ of 15 mm Hg from BL; high diastolic blood pressure: > 85 and ↑ of 12 mm Hg from BL (ages 5-18). Low heart rate: < 80 and and ↓ of 30 beats per minute (bpm) from BL (age 5-12), < 60 and and ↓ of 30 bpm from BL (age 13-18), < 50 and and ↓ of 15 bpm from BL (age > 18); high heart rate: > 120 and ↑ of 30 bpm from BL (age 5-12), > 100 and ↑ of 30 bpm from BL (age 13-18), > 100 and ↑ of 15 bpm from BL (age > 18). Low oral body temperature: < 35.8° Celsius (age 5 to >18); high oral body temperature: > 38.1° C and ↑ 2° Celsius from BL (age 5-18).
Time Frame From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open-Label Reslizumab
Hide Arm/Group Description:
Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
Overall Number of Participants Analyzed 190
Measure Type: Number
Unit of Measure: participants
Low systolic blood pressure 21
High systolic blood pressure 18
Low diastolic blood pressure 88
High diastolic blood pressure 27
Low heart rate 42
High heart rate 22
Low oral temperature 72
High oral temperature 2
5.Primary Outcome
Title Number of Participants With Newly Diagnosed Physical Examination Abnormalities at Endpoint
Hide Description HEENT=head, eyes, ears, nose and throat.
Time Frame From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open-Label Reslizumab
Hide Arm/Group Description:
Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
Overall Number of Participants Analyzed 190
Measure Type: Number
Unit of Measure: participants
General appearance 0
HEENT 7
Neck/thyroid 0
Skin 4
Lymph nodes 0
Heart 1
Chest and lungs 3
Neurological cranial nerves 0
Neurological strength 0
Neurological sensation 0
Neurological reflexes 0
Other 9
6.Primary Outcome
Title Infusion Site Evaluations
Hide Description The infusion site was assessed before treatment and within 30 minutes after the end of the infusion at each monthly treatment visit (or at early withdrawal if before Week 16). The infusion site was graded according to a 5-point scale as follows: 0=no tenderness at IV site, no erythema, no swelling, no induration, no purulence, no palpable venous cord; 1=tender IV site, no erythema, no swelling, no induration, no purulence, no palpable venous cord; 2=tender IV site with erythema, some degree of swelling, no induration, no purulence, no palpable venous cord; 3=tender IV site with erythema and swelling, with induration or palpable venous cord, no purulence; 4=frank vein thrombosis, along with all signs of grade 3 with purulence; IV may stop running because of thrombosis. After the 16-week visit, formal infusion site evaluations were not continued. However, any infusion site reactions were recorded as adverse events and graded as other adverse events.
Time Frame Day 0, Weeks 4, 8, 12, 16, endpoint (last visit), any time during study (mean [SD] duration of treatment was 30.0 [5.89] months)
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Hide Analysis Population Description
Number of Participants Analyzed= all participants in study (n=190); n=number of participants graded at given time point.
Arm/Group Title Grade 0 Grade 1 Grade 2 Grade 3 Grade 4
Hide Arm/Group Description:
Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly with an infusion site evaluation grade 0.
Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly with an infusion site evaluation grade 1.
Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly with an infusion site evaluation grade 2.
Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly with an infusion site evaluation grade 3.
Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly with an infusion site evaluation grade 4.
Overall Number of Participants Analyzed 190 190 190 190 190
Measure Type: Number
Unit of Measure: participants
Day 0; n=190 178 11 1 0 0
Week 4; n=188 179 8 1 0 0
Week 8; n=184 181 2 1 0 0
Week 12; n=181 175 4 1 1 0
Week 16; n=159 154 4 1 0 0
Endpoint; n=190 185 4 1 0 0
Any time; n=190 190 25 3 1 0
7.Primary Outcome
Title Therapeutic Classification of Concomitant Medications in at Least 10% of Participants
Hide Description Number of participants receiving therapeutic classes of concomitant medications.
Time Frame From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open-Label Reslizumab
Hide Arm/Group Description:
Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
Overall Number of Participants Analyzed 190
Measure Type: Number
Unit of Measure: participants
Any concomitant medication 176
Analgesics 93
Antibacterials for systemic use 117
Antiemetics and antinauseants 28
Antihistamines for systemic use 123
Antiinflammatory and antirheumatic products 83
Antipruritics, including antihistamine,anesthetic 26
Antivirals for systemic use 24
Corticosteroids for systemic use 40
Corticosteroids, dermatological preparations 27
Cough and cold preparations 55
Drugs for acid-related disorders 59
Drugs for obstructive airway diseases 93
Laxatives 26
Mineral supplements 20
Nasal preparations 73
Ophthalmologicals 19
Psychoanaleptics 49
Psycholeptics 33
Vaccines 31
Vitamins 36
8.Secondary Outcome
Title Mean Change From Baseline to Endpoint in Peak Esophageal Eosinophil Counts
Hide Description The mean change from baseline in esophageal eosinophil levels was described at week 16 or early withdrawal (if before week 16), using descriptive statistics. Baseline was defined as the last assessment before the first dose of reslizumab, which was the baseline of the double-blind study (NCT00538434) for patients who received reslizumab in the double blind study or the baseline of the open-label study for patients who received placebo during the double-blind study.
Time Frame Baseline, Week 16 or early withdrawal (if before Week 16)
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Hide Analysis Population Description
Participants with an assessment at Baseline and Week 16 (or early withdrawal).
Arm/Group Title Open-Label Reslizumab
Hide Arm/Group Description:
Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
Overall Number of Participants Analyzed 179
Mean (Standard Deviation)
Unit of Measure: eosinophils/high power field (hpf)
-62.0  (77.97)
9.Secondary Outcome
Title Participant's EoE Predominant Symptoms Over Time
Hide Description The data from the patient’s/parent’s eosinophilic esophagitis (EoE) Symptom Assessment were used to assess the shift from baseline in Predominant Symptom Assessment. The predominant symptom of the participant’s/parent’s EoE Symptom Assessment was selected at the double-blind baseline visit and remained the same throughout this study. Using the EoE Symptom Assessment, the participant/parent or legal guardian rated the severity of the previous week’s EoE symptoms as none, mild, moderate, severe, or very severe on a 5-point scale. Only the predominant symptom selected for each participant contributed to the overall analysis of the Predominant Symptom Assessment and the subgroup analyses of individual symptoms. Thus, for the Predominant Symptom Analysis, some patients had dysphagia assessed, while others had either abdominal/chest pain or vomiting/regurgitation assessed.
Time Frame Every 3 weeks from Day 0 up to Week 42 (mean [SD] duration of treatment was 30.0 [5.89] months)
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Hide Analysis Population Description
The statistical analysis plan only specified that data would be summarized/described graphically for visual inspection and cannot be summarized.
Arm/Group Title Open-Label Reslizumab
Hide Arm/Group Description:
Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Physician's EoE Global Assessment Over Time
Hide Description The data from the participant’s/parent’s EoE Symptom Assessment, in combination with other observations, were used by physicians to determine the Physician’s EoE Global Assessment. All components of the patient’s EoE Symptom Assessment were used by physicians to determine the Physician’s EoE Global Assessment.
Time Frame Every 3 weeks from Day 0 up to Week 42 (mean [SD] duration of treatment was 30.0 [5.89] months)
Hide Outcome Measure Data
Hide Analysis Population Description
The statistical analysis plan only specified that data would be summarized/described graphically for visual inspection and cannot be summarized.
Arm/Group Title Open-Label Reslizumab
Hide Arm/Group Description:
Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Mean Change From Baseline to Endpoint in Selected Child Health Questionnaire (CHQ) Scores
Hide Description The Child Health Questionnaire comprises 50 items. Specific items are recoded and/or recalibrated. Raw scores for scales (domains calculated over one or more items) are then calculated following set algorithms. The raw scales are then transformed to 0 to 100 scores, except for Change in Health which remains a 1-5 score. Finally two summary measures are calculated based on weighted combinations of selected scales. The Global Health, Physical Summary Score and Psychosocial Summary Score were summarized. For each, scores range from 0 (higher disease activity) to 100 (lower disease activity); higher scores indicate better health.
Time Frame Baseline through Endpoint (last visit; mean [SD] duration of treatment was 30.0 [5.89] months)
Hide Outcome Measure Data
Hide Analysis Population Description
n=participants with an assessment for the given score at Baseline and Endpoint.
Arm/Group Title Open-Label Reslizumab
Hide Arm/Group Description:
Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
Overall Number of Participants Analyzed 190
Mean (Standard Deviation)
Unit of Measure: units on a scale
Global Health; n=181 4.6  (20.62)
Physical Summary Scale; n=170 3.7  (9.26)
Psychosocial Summary Scale; n=170 3.1  (8.83)
12.Secondary Outcome
Title Dietary Question Responses at Endpoint
Hide Description Number of participants answering that they either maintained or changed their diet from the beginning of the double-blind study (ie, NCT00538434). Additionally, for those participants who answered that they changed their diet from the beginning of the double-blind study (column 2), the number of participants in that group who changed by increasing the consistency of their food ('Increased consistency') and the percentage that changed by eating foods that previously worsened EoE ('Added foods'). (Note that these 2 categories are not mutually exclusive, so that someone could have both increased the consistency of the food they were eating AND also eaten foods that previously worsened their EoE symptoms.)
Time Frame Study endpoint (mean [SD] duration of treatment was 30.0 [5.89] months)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants Analyzed=all participants (n=190). The denominator for follow-up questions is the number of participants responding ‘No’ to the question “Have you maintained your diet since the beginning of the study?” (n=63).
Arm/Group Title Maintained Diet From Beginning of Double-blind Study Changed Diet From Beginning of Double-blind Study Changed by Increasing Consistency of Food Changed by Eating Foods That Previously Worsened EoE
Hide Arm/Group Description:
Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly who maintained their diet from the beginning of the double-blind study (NCT00538434).
Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly who changed their diet from the beginning of the double-blind study (NCT00538434).
Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly who changed their diet from the beginning of the double-blind study (NCT00538434) by increasing the consistency of their food.
Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly who changed their diet from the beginning of the double-blind study (NCT00538434) by eating foods that previously worsened EoE.
Overall Number of Participants Analyzed 190 190 63 63
Measure Type: Number
Unit of Measure: participants
124 63 21 46
13.Secondary Outcome
Title Reslizumab Serum Concentrations
Hide Description Reslizumab serum concentrations obtained in this study were included in ongoing and separate population pharmacokinetic analyses. The Number of Participants Analyzed reflects the number of participants who had concentrations measured following that dose level. Since some participants started on 1 mg/kg and later increased to 2 mg/kg (and are therefore represented in more than one column), the number of participants in each column add up to a greater number than the total in the overall column, which reflects the total number of participants with measurable concentration data in this study. The number of concentrations summarized for that dose level represents more than one concentration per participant in most cases.
Time Frame Before treatment (within 3 hours) and after treatment (within 3 hours after end of infusion) for doses at Weeks 8 and 12; within 6 days after either dose at Weeks 8 or 12; 2 to 4 weeks after dose at Weeks 8 or 12; and at premature withdrawal.
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Hide Analysis Population Description
Number of participants with measurable concentration data at each dose level and overall.
Arm/Group Title Open-Label Reslizumab: 1 mg/kg Open-Label Reslizumab: 2 mg/kg Open-Label Reslizumab: 3 mg/kg Open-Label Reslizumab: Overall
Hide Arm/Group Description:
Open-label reslizumab IV infusion at 1 mg/kg monthly
Open-label reslizumab IV infusion at 2 mg/kg monthly
Open-label reslizumab IV infusion at 3 mg/kg monthly
Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly, continued at 1 to 3 mg/kg monthly
Overall Number of Participants Analyzed 162 100 6 179
Overall Number of Units Analyzed
Type of Units Analyzed: Concentrations
563 348 9 920
Mean (Standard Deviation)
Unit of Measure: µg/mL
15.747  (11.293) 29.507  (20.592) 41.360  (54.952) 21.202  (17.684)
14.Secondary Outcome
Title Number of Participants With >/= 1 Confirmed Positive Value for Anti-drug Antibodies (ADA)
Hide Description Using a validated enzyme-linked immunosorbent assay (ELISA), the number of participants who had at least 1 confirmed positive value for ADA, either on day 0 after having received reslizumab in the double-blind study Res-05-0002 (NCT00538434) or during the course of the open-label study.
Time Frame From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment.
Arm/Group Title Open-Label Reslizumab
Hide Arm/Group Description:
Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
Overall Number of Participants Analyzed 189
Measure Type: Number
Unit of Measure: participants
6
Time Frame Day 0 through the end of study. The mean duration of treatment within the open-label extension for all participants was 24.7 months (range, 0.0 to 40.5 months).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Open-Label Reslizumab
Hide Arm/Group Description Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
All-Cause Mortality
Open-Label Reslizumab
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Open-Label Reslizumab
Affected / at Risk (%) # Events
Total   21/190 (11.05%)    
Blood and lymphatic system disorders   
Neutropenia  1  1/190 (0.53%)  1
Gastrointestinal disorders   
Abdominal pain  1  2/190 (1.05%)  3
Abdominal pain lower  1  1/190 (0.53%)  1
Constipation  1  1/190 (0.53%)  1
Hiatus hernia  1  1/190 (0.53%)  1
Immune system disorders   
Anaphylactic reaction  1  1/190 (0.53%)  1
Infections and infestations   
Appendicitis  1  1/190 (0.53%)  1
Cellulitis  1  1/190 (0.53%)  1
Viral infection  1  1/190 (0.53%)  1
Wound infection  1  1/190 (0.53%)  1
Injury, poisoning and procedural complications   
Concussion  1  1/190 (0.53%)  1
Contusion  1  1/190 (0.53%)  1
Foreign body trauma  1  1/190 (0.53%)  1
Pelvic fracture  1  1/190 (0.53%)  1
Rib fracture  1  1/190 (0.53%)  1
Road traffic accident  1  2/190 (1.05%)  2
Skin laceration  1  1/190 (0.53%)  1
Splenic rupture  1  1/190 (0.53%)  1
Metabolism and nutrition disorders   
Dehydration  1  1/190 (0.53%)  1
Diabetic ketoacidosis  1  1/190 (0.53%)  3
Hypoglycaemic seizure  1  1/190 (0.53%)  1
Nervous system disorders   
Grand mal convulsion  1  1/190 (0.53%)  1
Psychiatric disorders   
Depression  1  2/190 (1.05%)  2
Suicide attempt  1  1/190 (0.53%)  1
Respiratory, thoracic and mediastinal disorders   
Asthma  1  2/190 (1.05%)  2
Surgical and medical procedures   
Hospitalisation  1  1/190 (0.53%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Open-Label Reslizumab
Affected / at Risk (%) # Events
Total   167/190 (87.89%)    
Blood and lymphatic system disorders   
Lymphadenopathy  1  17/190 (8.95%)  18
Gastrointestinal disorders   
Abdominal pain  1  22/190 (11.58%)  23
Abdominal pain upper  1  17/190 (8.95%)  51
Constipation  1  17/190 (8.95%)  20
Diarrhoea  1  25/190 (13.16%)  38
Nausea  1  23/190 (12.11%)  27
Vomiting  1  27/190 (14.21%)  37
General disorders   
Fatigue  1  12/190 (6.32%)  21
Pyrexia  1  29/190 (15.26%)  41
Immune system disorders   
Food allergy  1  15/190 (7.89%)  16
Seasonal allergy  1  21/190 (11.05%)  27
Infections and infestations   
Bronchitis  1  14/190 (7.37%)  18
Ear infection  1  19/190 (10.00%)  22
Gastroenteritis  1  15/190 (7.89%)  23
Gastroenteritis viral  1  30/190 (15.79%)  37
Influenza  1  37/190 (19.47%)  40
Nasopharyngitis  1  40/190 (21.05%)  64
Otitis media  1  10/190 (5.26%)  12
Sinusitis  1  35/190 (18.42%)  55
Upper respiratory tract infection  1  45/190 (23.68%)  82
Viral infection  1  14/190 (7.37%)  15
Injury, poisoning and procedural complications   
Excoriation  1  12/190 (6.32%)  12
Musculoskeletal and connective tissue disorders   
Arthralgia  1  14/190 (7.37%)  18
Pain in extremity  1  15/190 (7.89%)  19
Nervous system disorders   
Dizziness  1  14/190 (7.37%)  20
Headache  1  50/190 (26.32%)  118
Migraine  1  11/190 (5.79%)  14
Respiratory, thoracic and mediastinal disorders   
Asthma  1  28/190 (14.74%)  56
Cough  1  31/190 (16.32%)  69
Nasal congestion  1  20/190 (10.53%)  31
Pharyngolaryngeal pain  1  53/190 (27.89%)  85
Rhinitis allergic  1  10/190 (5.26%)  10
Skin and subcutaneous tissue disorders   
Acne  1  10/190 (5.26%)  10
Rash  1  20/190 (10.53%)  38
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
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: NCT00635089     History of Changes
Other Study ID Numbers: Res-5-0004
First Submitted: March 6, 2008
First Posted: March 13, 2008
Results First Submitted: March 23, 2016
Results First Posted: March 23, 2017
Last Update Posted: March 23, 2017