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Safety and Pharmacokinetic Study of ALO-02 in Children Ages 7-17 With Pain

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: NCT02680847
Recruitment Status : Terminated (The trial was terminated on 08FEB2018. Pfizer has decided to withdraw the New Drug Application and has notified FDA. There are no efficacy or safety concerns.)
First Posted : February 12, 2016
Results First Posted : September 25, 2018
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Masking: None (Open Label);   Primary Purpose: Treatment
Condition Moderate-severe Pain
Intervention Drug: ALO-02
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ALO-02 <=20 mg ALO-02 >20-40 mg ALO-02 >40-80 mg
Hide Arm/Group Description Oral ALO-02 capsules average daily dose ≤ 20 mg BID (the average daily dose is the total dose amount divided by the total treatment days) Oral ALO-02 capsules average daily dose >20-40 mg BID (the average daily dose is the total dose amount divided by the total treatment days) Oral ALO-02 capsules average daily dose > 40-80 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
Period Title: Overall Study
Started 16 9 7
Completed 11 6 4
Not Completed 5 3 3
Reason Not Completed
Other             2             0             0
No longer met eligibility criteria             2             2             0
Unwilling to participate in study             1             1             0
Lack of Efficacy             0             0             2
Adverse Event             0             0             1
Arm/Group Title ALO-02 <=20 mg ALO-02 >20-40 mg ALO-02 >40-80 mg Total
Hide Arm/Group Description Oral ALO-02 capsules average daily dose ≤ 20 mg BID (the average daily dose is the total dose amount divided by the total treatment days) Oral ALO-02 capsules average daily dose >20-40 mg BID (the average daily dose is the total dose amount divided by the total treatment days) Oral ALO-02 capsules average daily dose > 40-80 mg BID (the average daily dose is the total dose amount divided by the total treatment days) Total of all reporting groups
Overall Number of Baseline Participants 16 9 7 32
Hide Baseline Analysis Population Description
The baseline analysis population included all participants in the treatment period (including titration phase and maintenance phase) who received at least 1 dose of ALO-02. This study was single-arm and data was reported by 3 arms to show dose related differences. The results were combined, not separated by 2 phases, due to study termination.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 9 participants 7 participants 32 participants
13.4  (2.0) 15.2  (1.3) 15.3  (1.1) 14.0  (2.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 9 participants 7 participants 32 participants
Female
4
  25.0%
4
  44.4%
5
  71.4%
13
  40.6%
Male
12
  75.0%
5
  55.6%
2
  28.6%
19
  59.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 9 participants 7 participants 32 participants
White
15
  93.8%
6
  66.7%
5
  71.4%
26
  81.3%
Black
1
   6.3%
3
  33.3%
2
  28.6%
6
  18.8%
1.Primary Outcome
Title Average Steady-state Concentration (Css, av) of Oxycodone
Hide Description ALO-02 capsules consist of controlled-release pellets containing oxycodone hydrochloride (HCl) and naltrexone HCl. Oxycodone is a main component of this product.
Time Frame Visit 4 (Day 21,28,35 or 42) or Visit 5 if not collected at Visit 4 (early termination or end of study, which occurred on Day 35,42,49 or 56) in Maintenance Phase
Hide Outcome Measure Data
Hide Analysis Population Description
The PK samples were collected but not analyzed and discarded due to early termination of the study.
Arm/Group Title ALO-02 <= 20 mg ALO-02 >20-40 mg ALO-02 >40-80 mg
Hide Arm/Group Description:
Oral ALO-02 capsules average daily dose ≤ 20 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
Oral ALO-02 capsules average daily dose >20-40 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
Oral ALO-02 capsules average daily dose > 40-80 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Apparent Oral Clearance (CL/F) of Oxycodone
Hide Description ALO-02 capsules consist of controlled-release pellets containing oxycodone hydrochloride (HCl) and naltrexone HCl. Oxycodone is a main component of this product.
Time Frame Visit 4 (Day 21,28,35 or 42) or Visit 5 if not collected at Visit 4 (early termination or end of study, which occurred on Day 35,42,49 or 56) in Maintenance Phase
Hide Outcome Measure Data
Hide Analysis Population Description
The PK samples were collected but not analyzed and discarded due to early termination of the study.
Arm/Group Title ALO-02 <= 20 mg ALO-02 >20-40 mg ALO-02 >40-80 mg
Hide Arm/Group Description:
Oral ALO-02 capsules average daily dose ≤ 20 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
Oral ALO-02 capsules average daily dose >20-40 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
Oral ALO-02 capsules average daily dose > 40-80 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Number of Participants With All-causality and Treatment-related Adverse Events (AEs)
Hide Description An AE was any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. All-causality AEs refer to any AE occurrence which needed not necessarily have a causal relationship with the treatment or usage. Treatment-related AEs refer to AEs that have a causal relationship with the treatment or usage. The majority of AEs were of mild to moderate severity.
Time Frame Baseline up to Day 63
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population consisted of all subjects who participated in the treatment period and received at least 1 dose of ALO-02.
Arm/Group Title ALO-02 <= 20 mg ALO-02 >20-40 mg ALO-02 >40-80 mg
Hide Arm/Group Description:
Oral ALO-02 capsules average daily dose ≤ 20 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
Oral ALO-02 capsules average daily dose >20-40 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
Oral ALO-02 capsules average daily dose > 40-80 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
Overall Number of Participants Analyzed 16 9 7
Measure Type: Count of Participants
Unit of Measure: Participants
All-causality AEs
14
  87.5%
8
  88.9%
7
 100.0%
Treatment-related AEs
9
  56.3%
6
  66.7%
6
  85.7%
4.Primary Outcome
Title Number of All-causality and Treatment-related AEs, by Intensity
Hide Description An AE was any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. All-causality AEs refer to any AE occurrence which needed not necessarily have a causal relationship with the treatment or usage. Treatment-related AEs refer to AEs that have a causal relationship with the treatment or usage. The majority of AEs were of mild to moderate severity.
Time Frame Baseline up to Day 63
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population consisted of all subjects who participated in the treatment period and received at least 1 dose of ALO-02.
Arm/Group Title ALO-02 <= 20 mg ALO-02 >20-40 mg ALO-02 >40-80 mg
Hide Arm/Group Description:
Oral ALO-02 capsules average daily dose ≤ 20 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
Oral ALO-02 capsules average daily dose >20-40 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
Oral ALO-02 capsules average daily dose > 40-80 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
Overall Number of Participants Analyzed 16 9 7
Measure Type: Number
Unit of Measure: Events
All-causality AEs (mild) 38 32 26
All-causality AEs (moderate) 15 10 12
All-causality AEs (severe) 0 0 3
Treatment-related AEs (mild) 19 24 16
Treatment-related AEs (moderate) 6 4 6
Treatment-related AEs (severe) 0 0 0
5.Primary Outcome
Title Number of Participants With All-causality and Treatment-related Serious Adverse Events (SAEs)
Hide Description An SAE was any untoward medical occurrence at any dose that: resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. All-causality SAEs refer to any SAE occurrence which needed not necessarily have a causal relationship with the treatment or usage. Treatment-related SAEs refer to SAEs that have a causal relationship with the treatment or usage.
Time Frame Baseline up to Day 63
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population consisted of all subjects who participated in the treatment period and received at least 1 dose of ALO-02.
Arm/Group Title ALO-02 <= 20 mg ALO-02 >20-40 mg ALO-02 >40-80 mg
Hide Arm/Group Description:
Oral ALO-02 capsules average daily dose ≤ 20 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
Oral ALO-02 capsules average daily dose >20-40 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
Oral ALO-02 capsules average daily dose > 40-80 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
Overall Number of Participants Analyzed 16 9 7
Measure Type: Count of Participants
Unit of Measure: Participants
All-causality
0
   0.0%
0
   0.0%
2
  28.6%
Treatment-related
0
   0.0%
0
   0.0%
0
   0.0%
6.Primary Outcome
Title Number of Participants With Clinical Opiate Withdrawal Scale (COWS)
Hide Description The COWS contains 11 common opiate withdrawal signs or symptoms rated by the clinician.The summed score of the 11 items is used to assess a subject’s level of withdrawal. A subject assessed with a COWS score>= 13 was treated for opiate withdrawal signs and symptoms according to the investigator’s medical judgment. The total COWS score ranges from 0 to 48. Higher scores indicate worse outcome. Different score ranges represent different severities of withdrawal: no withdrawal (<5), mild (5-12), moderate (13-24), moderately severe (25-36), and severe (>36)
Time Frame Screening, Day 1, Titration Phase: Weeks 1,2,3,4; end of titration phase; Maintenance phase: Weeks 2, 4; early termination at titration phase, end of maintenance phase.
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population consisted of all subjects who participated in the treatment period and received at least 1 dose of ALO-02.
Arm/Group Title ALO-02 <= 20 mg ALO-02 >20-40 mg ALO-02 >40-80 mg
Hide Arm/Group Description:
Oral ALO-02 capsules average daily dose ≤ 20 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
Oral ALO-02 capsules average daily dose >20-40 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
Oral ALO-02 capsules average daily dose > 40-80 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
Overall Number of Participants Analyzed 16 9 7
Measure Type: Count of Participants
Unit of Measure: Participants
COWS score<5 (screening)
15
  93.8%
9
 100.0%
7
 100.0%
COWS score 5-12 (mild) (screening)
1
   6.3%
0
   0.0%
0
   0.0%
COWS score<5 (end of maintenance phase)
15
  93.8%
8
  88.9%
7
 100.0%
COWS score 5-12 (mild) (end of maintenance phase)
1
   6.3%
1
  11.1%
0
   0.0%
7.Secondary Outcome
Title Apparent Volume of Distribution (Vz/F) of Oxycodone
Hide Description ALO-02 capsules consist of controlled-release pellets containing oxycodone hydrochloride (HCl) and naltrexone HCl. Oxycodone is a main component of this product.
Time Frame Visit 4 (Day 21,28,35 or 42) or Visit 5 if not collected at Visit 4 (early termination or end of study, which occurred on Day 35,42,49 or 56) in Maintenance Phase
Hide Outcome Measure Data
Hide Analysis Population Description
The PK samples were collected but not analyzed and discarded due to early termination of the study.
Arm/Group Title ALO-02 <= 20 mg ALO-02 >20-40 mg ALO-02 >40-80 mg
Hide Arm/Group Description:
Oral ALO-02 capsules average daily dose ≤ 20 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
Oral ALO-02 capsules average daily dose >20-40 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
Oral ALO-02 capsules average daily dose > 40-80 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Systemic Exposure Levels of the Metabolites of Oxycodone (Oxymorphone and Noroxycodone), Naltrexone, and 6-β-naltrexol.
Hide Description Oxymorphone and noroxycodone are major metabolites of Oxycodone and 6-β-naltrexol is the major metabolite of naltrexol.
Time Frame Visit 4 (Day 21,28,35 or 42) or Visit 5 if not collected at Visit 4 (early termination or end of study, which occurred on Day 35,42,49 or 56) in Maintenance Phase
Hide Outcome Measure Data
Hide Analysis Population Description
The PK samples were collected but not analyzed and discarded due to early termination of the study.
Arm/Group Title ALO-02 <= 20 mg ALO-02 >20-40 mg ALO-02 >40-80 mg
Hide Arm/Group Description:
Oral ALO-02 capsules average daily dose ≤ 20 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
Oral ALO-02 capsules average daily dose >20-40 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
Oral ALO-02 capsules average daily dose > 40-80 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Number of Participants With Maximum Changes in Vital Signs (Blood Pressure, Heart Rate, Respiratory Rate) Meeting Categorical Summarization Criteria
Hide Description Following parameters were analyzed for examinations of vital signs: resting systolic and diastolic blood pressure, heart rate, and respiratory rate. In this study, there were only participants meeting the maximum decrease from baseline in systolic blood pressure (SBP) >= 30 mmHg and diastolic blood pressure (DBP) >=20 mmHg criteria. None of the vital sign changes were clinically significant.
Time Frame Baseline up to Day 58
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population consisted of all subjects who participated in the treatment period and received at least 1 dose of ALO-02.
Arm/Group Title ALO-02 <= 20 mg ALO-02 >20-40 mg ALO-02 >40-80 mg
Hide Arm/Group Description:
Oral ALO-02 capsules average daily dose ≤ 20 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
Oral ALO-02 capsules average daily dose >20-40 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
Oral ALO-02 capsules average daily dose > 40-80 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
Overall Number of Participants Analyzed 16 9 7
Measure Type: Count of Participants
Unit of Measure: Participants
Maximum decrease from baseline in SBP>=30mmHg
1
   6.3%
0
   0.0%
1
  14.3%
Maximum decrease from baseline in DBP>=20mmHg
1
   6.3%
2
  22.2%
0
   0.0%
10.Secondary Outcome
Title Number of Participants With Laboratory (Lab) Abnormalities (Hematology and Chemistry)
Hide Description Following parameters were analyzed for hematologic laboratory tests: hemoglobin, hematocrit, red blood cells, mean corpuscular volume, platelets, white blood cells, lymphocytes (absolute & %), neutrophils (absolute & %), basophils (absolute & %), eosinophils (absolute &%), monocytes (absolute & %). Following parameters were analyzed for chemical laboratory tests: bilirubin,aspartate aminotransferase, alanine aminotransferase,alkaline phosphatase, protein(total), albumin,blood urea nitrogen, creatinine, cholesterol, sodium, potassium,chloride, calcium, phosphate, bicarbonate, glucose, creatine kinase. None of the lab abnormalities were clinically significant.
Time Frame Baseline up to Day 77
Hide Outcome Measure Data
Hide Analysis Population Description
The laboratory data analysis set included only those participants who had post baseline lab results.
Arm/Group Title ALO-02 <= 20 mg ALO-02 >20-40 mg ALO-02 >40-80 mg
Hide Arm/Group Description:
Oral ALO-02 capsules average daily dose ≤ 20 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
Oral ALO-02 capsules average daily dose >20-40 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
Oral ALO-02 capsules average daily dose > 40-80 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
Overall Number of Participants Analyzed 15 9 7
Measure Type: Count of Participants
Unit of Measure: Participants
Hematology
8
  53.3%
5
  55.6%
4
  57.1%
Chemistry
1
   6.7%
3
  33.3%
3
  42.9%
Time Frame Baseline up to Day 63
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
 
Arm/Group Title ALO-02 <=20 mg ALO-02 >20-40 mg ALO-02 >40-80 mg
Hide Arm/Group Description Oral ALO-02 capsules average daily dose ≤ 20 mg BID (the average daily dose is the total dose amount divided by the total treatment days) Oral ALO-02 capsules average daily dose >20-40 mg BID (the average daily dose is the total dose amount divided by the total treatment days) Oral ALO-02 capsules average daily dose > 40-80 mg BID (the average daily dose is the total dose amount divided by the total treatment days)
All-Cause Mortality
ALO-02 <=20 mg ALO-02 >20-40 mg ALO-02 >40-80 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/9 (0.00%)   0/7 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
ALO-02 <=20 mg ALO-02 >20-40 mg ALO-02 >40-80 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/9 (0.00%)   2/7 (28.57%) 
Nervous system disorders       
Migraine * 1  0/16 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Seizure * 1  0/16 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Psychiatric disorders       
Suicidal ideation * 1  0/16 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
1
Term from vocabulary, MedDRA 20.1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ALO-02 <=20 mg ALO-02 >20-40 mg ALO-02 >40-80 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/16 (87.50%)   8/9 (88.89%)   7/7 (100.00%) 
Endocrine disorders       
Hyperprolactinaemia * 1  0/16 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Eye disorders       
Miosis * 1  0/16 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Vision blurred * 1  0/16 (0.00%)  1/9 (11.11%)  2/7 (28.57%) 
Gastrointestinal disorders       
Abdominal discomfort * 1  0/16 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Abdominal pain * 1  1/16 (6.25%)  0/9 (0.00%)  0/7 (0.00%) 
Abdominal pain upper * 1  2/16 (12.50%)  0/9 (0.00%)  3/7 (42.86%) 
Constipation * 1  2/16 (12.50%)  2/9 (22.22%)  0/7 (0.00%) 
Oral disorder * 1  0/16 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Vomiting * 1  3/16 (18.75%)  4/9 (44.44%)  2/7 (28.57%) 
Nausea * 1  5/16 (31.25%)  4/9 (44.44%)  2/7 (28.57%) 
General disorders       
Asthenia * 1  0/16 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Chest discomfort * 1  0/16 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Chest pain * 1  1/16 (6.25%)  0/9 (0.00%)  0/7 (0.00%) 
Fatigue * 1  0/16 (0.00%)  2/9 (22.22%)  0/7 (0.00%) 
Feeling abnormal * 1  0/16 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Feeling jittery * 1  0/16 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Feeling of body temperature change * 1  1/16 (6.25%)  0/9 (0.00%)  0/7 (0.00%) 
Pain * 1  1/16 (6.25%)  1/9 (11.11%)  1/7 (14.29%) 
Peripheral swelling * 1  1/16 (6.25%)  0/9 (0.00%)  0/7 (0.00%) 
Pyrexia * 1  2/16 (12.50%)  0/9 (0.00%)  0/7 (0.00%) 
Infections and infestations       
Nasopharyngitis * 1  1/16 (6.25%)  0/9 (0.00%)  0/7 (0.00%) 
Pharyngitis bacterial * 1  0/16 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Urinary tract infection * 1  0/16 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Viral infection * 1  0/16 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Vulvovaginal mycotic infection * 1  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%) 
Injury, poisoning and procedural complications       
Fall * 1  1/16 (6.25%)  0/9 (0.00%)  0/7 (0.00%) 
Limb injury * 1  1/16 (6.25%)  0/9 (0.00%)  0/7 (0.00%) 
Investigations       
Cardiac murmur * 1 [1]  0/16 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Hepatic enzyme increased * 1  0/16 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Weight increased * 1  0/16 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Metabolism and nutrition disorders       
Decreased appetite * 1  1/16 (6.25%)  3/9 (33.33%)  1/7 (14.29%) 
Musculoskeletal and connective tissue disorders       
Back pain * 1  0/16 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Flank pain * 1  0/16 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Muscle spasms * 1  3/16 (18.75%)  0/9 (0.00%)  0/7 (0.00%) 
Musculoskeletal chest pain * 1  0/16 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Neck pain * 1  1/16 (6.25%)  0/9 (0.00%)  0/7 (0.00%) 
Pain in extremity * 1  1/16 (6.25%)  0/9 (0.00%)  1/7 (14.29%) 
Nervous system disorders       
Burning sensation * 1  1/16 (6.25%)  0/9 (0.00%)  0/7 (0.00%) 
Disturbance in attention * 1  1/16 (6.25%)  0/9 (0.00%)  0/7 (0.00%) 
Dizziness * 1  1/16 (6.25%)  4/9 (44.44%)  2/7 (28.57%) 
Dizziness exertional * 1  0/16 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Dysarthria * 1  1/16 (6.25%)  0/9 (0.00%)  0/7 (0.00%) 
Headache * 1  3/16 (18.75%)  0/9 (0.00%)  0/7 (0.00%) 
Lethargy * 1  1/16 (6.25%)  0/9 (0.00%)  0/7 (0.00%) 
Loss of consciousness * 1  1/16 (6.25%)  0/9 (0.00%)  0/7 (0.00%) 
Migraine * 1  0/16 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Somnolence * 1  1/16 (6.25%)  3/9 (33.33%)  2/7 (28.57%) 
Tremor * 1  0/16 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Psychiatric disorders       
Anxiety * 1  1/16 (6.25%)  0/9 (0.00%)  1/7 (14.29%) 
Depression * 1  0/16 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Insomnia * 1  3/16 (18.75%)  1/9 (11.11%)  0/7 (0.00%) 
Irritability * 1  1/16 (6.25%)  1/9 (11.11%)  0/7 (0.00%) 
Paranoia * 1  0/16 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Restlessness * 1  1/16 (6.25%)  0/9 (0.00%)  0/7 (0.00%) 
Social anxiety disorder * 1  1/16 (6.25%)  0/9 (0.00%)  0/7 (0.00%) 
Renal and urinary disorders       
Urinary hesitation * 1  0/16 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Urinary incontinence * 1  1/16 (6.25%)  0/9 (0.00%)  0/7 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Allergic sinusitis * 1  0/16 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Bronchospasm * 1  0/16 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Dyspnoea * 1  1/16 (6.25%)  1/9 (11.11%)  0/7 (0.00%) 
Epistaxis * 1  0/16 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Hiccups * 1  0/16 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Nasal dryness * 1  1/16 (6.25%)  0/9 (0.00%)  0/7 (0.00%) 
Oropharyngeal pain * 1  0/16 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Skin and subcutaneous tissue disorders       
Acne * 1  0/16 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Cold sweat * 1  0/16 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Decubitus ulcer * 1  0/16 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Eczema * 1  0/16 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Hyperhidrosis * 1  1/16 (6.25%)  1/9 (11.11%)  0/7 (0.00%) 
Pruritus * 1  1/16 (6.25%)  0/9 (0.00%)  1/7 (14.29%) 
Pruritus generalized * 1  0/16 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Rash * 1  2/16 (12.50%)  0/9 (0.00%)  0/7 (0.00%) 
Rash macular * 1  1/16 (6.25%)  0/9 (0.00%)  0/7 (0.00%) 
Swelling face * 1  0/16 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
1
Term from vocabulary, MedDRA 20.1
*
Indicates events were collected by non-systematic assessment
[1]
This event occurred on Study Day -2 and should be included in medical history instead of AE section. The error was not identified until after database lock.
The study was terminated due to sponsor's decision instead of safety or efficacy reasons. Early termination led to small numbers of participants summarized or described and PK samples were not analyzed.
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02680847     History of Changes
Other Study ID Numbers: B4531015
ALO-02 PHASE 4 PEDIATRIC STUDY ( Other Identifier: Alias Study Number )
First Submitted: January 20, 2016
First Posted: February 12, 2016
Results First Submitted: July 10, 2018
Results First Posted: September 25, 2018
Last Update Posted: September 25, 2018