Trial Outcomes & Findings for Immediate-Release Oxycodone Capsules Study in Cancer Pain (NCT NCT01675622)
NCT ID: NCT01675622
Last Updated: 2018-05-21
Results Overview
The numerical rating scale is the tool to assess pain level using a numerical rating scale. The primary outcome measurement is the average change of NRS score after double blind treatment between the two treatment groups. The NRS evaluates the pain level using number scale from 0 to 10. 0 means not painful and 10 means extremely painful. 1 to 3 is lightly pain, 4-6 is moderate pain and 7 to 10 is severe pain. There is no subscales used for NRS reporting.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
242 participants
Primary outcome timeframe
baseline up to 5-8 days (double blind period)
Results posted on
2018-05-21
Participant Flow
A total of 242 subjects were enrolled from 20 centers in which 192 subjects completed the study and 50 subjects did not completed the study. All the subjects were recruited from medical clinic.The recruitment period is from 2011 Jan to 2012 Mar.
Patients with moderate to severe cancer pain requiring oral opioid therapy were screened. All the patients who meets the inclusion/exclusion criteria were enrolled to double blind treatment phase. No wash our or run-in period required by protocol.
Participant milestones
| Measure |
Oxycodone Capsules for Cancer Pain
Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days. All patients completed the double-blind treatment entered into period 2.
period 2 is open treatment phase. Patients received two weeks treatment of oxycodone hydrochloride controlled-release tablets.
|
Morphine Tablets for Cancer Pain
Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours. All patients completed the double-blind treatment entered into period 2.
period 2 is open treatment phase. Patients received two weeks treatment of oxycodone hydrochloride controlled-release tablets.
|
|---|---|---|
|
Overall Study
STARTED
|
122
|
120
|
|
Overall Study
COMPLETED
|
96
|
96
|
|
Overall Study
NOT COMPLETED
|
26
|
24
|
Reasons for withdrawal
| Measure |
Oxycodone Capsules for Cancer Pain
Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days. All patients completed the double-blind treatment entered into period 2.
period 2 is open treatment phase. Patients received two weeks treatment of oxycodone hydrochloride controlled-release tablets.
|
Morphine Tablets for Cancer Pain
Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours. All patients completed the double-blind treatment entered into period 2.
period 2 is open treatment phase. Patients received two weeks treatment of oxycodone hydrochloride controlled-release tablets.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Adverse Event
|
12
|
10
|
|
Overall Study
Protocol Violation
|
4
|
1
|
|
Overall Study
Lack of Efficacy
|
2
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Other
|
5
|
4
|
Baseline Characteristics
Immediate-Release Oxycodone Capsules Study in Cancer Pain
Baseline characteristics by cohort
| Measure |
Oxycodone Capsules for Cancer Pain
n=120 Participants
Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
|
Morphine Tablets for Cancer Pain
n=118 Participants
Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours
|
Total
n=238 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.62 years
STANDARD_DEVIATION 12.96 • n=5 Participants
|
57.05 years
STANDARD_DEVIATION 12.07 • n=7 Participants
|
56.83 years
STANDARD_DEVIATION 12.50 • n=5 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
119 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
236 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
120 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
238 Participants
n=5 Participants
|
|
height
|
164.5 centimeter
STANDARD_DEVIATION 7.45 • n=5 Participants
|
164.99 centimeter
STANDARD_DEVIATION 8.20 • n=7 Participants
|
164.74 centimeter
STANDARD_DEVIATION 7.82 • n=5 Participants
|
|
weight
|
58.64 kg
STANDARD_DEVIATION 10.79 • n=5 Participants
|
58.34 kg
STANDARD_DEVIATION 11.01 • n=7 Participants
|
58.49 kg
STANDARD_DEVIATION 10.88 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline up to 5-8 days (double blind period)The numerical rating scale is the tool to assess pain level using a numerical rating scale. The primary outcome measurement is the average change of NRS score after double blind treatment between the two treatment groups. The NRS evaluates the pain level using number scale from 0 to 10. 0 means not painful and 10 means extremely painful. 1 to 3 is lightly pain, 4-6 is moderate pain and 7 to 10 is severe pain. There is no subscales used for NRS reporting.
Outcome measures
| Measure |
Oxycodone Capsules for Cancer Pain
n=120 Participants
Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
|
Morphine Tablets for Cancer Pain
n=118 Participants
Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours
|
|---|---|---|
|
Numerical Rating Scale (NRS)
|
3.91 scores on a scale
Standard Deviation 2.31
|
3.87 scores on a scale
Standard Deviation 2.22
|
SECONDARY outcome
Timeframe: baseline up to 5-8 days (double blind period)Population: The average total dosage during double-blind treatment was defined as a primary efficacy endpoint in the protocol, but this study was a non-inferiority study, and non-inferiority analysis could not be performed in average total dosage in data processing and statistics.
the average dose of study medicine used during double blind treatment period between the two treatment groups.
Outcome measures
| Measure |
Oxycodone Capsules for Cancer Pain
n=120 Participants
Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
|
Morphine Tablets for Cancer Pain
n=118 Participants
Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours
|
|---|---|---|
|
The Average Dose of Study Medicine Used During Double Blind Treatment Period
Average total dosage during double-blind titration
|
83.29 mg
Standard Deviation 82.87
|
141.61 mg
Standard Deviation 112.10
|
|
The Average Dose of Study Medicine Used During Double Blind Treatment Period
Ave. total dosage during double-blind maintenance
|
167.41 mg
Standard Deviation 103.92
|
308.63 mg
Standard Deviation 189.93
|
SECONDARY outcome
Timeframe: baseline up to 5-8 days (double blind period)The secondary outcome measurement is the change between BPI score at baseline and after completion of double blind treatment between the two treatment groups. The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. This tool measures the worst/least pain in the passed 24 hours, and the average/current pain in last 24 hours. The scale is numerically from 0 to 10. 0 means not painful, 10 means extremely painful. The BPI is the average number of above 4 BPI Pain Items.
Outcome measures
| Measure |
Oxycodone Capsules for Cancer Pain
n=120 Participants
Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
|
Morphine Tablets for Cancer Pain
n=118 Participants
Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours
|
|---|---|---|
|
Brief Pain Inventory (BPI) Change From Baseline to After Double Blind Period
Highest pain intensity in 24 hrs
|
4.25 scores on a scale
Standard Deviation 1.98
|
4.03 scores on a scale
Standard Deviation 2.20
|
|
Brief Pain Inventory (BPI) Change From Baseline to After Double Blind Period
Lowest pain intensity in 24 hrs
|
2.62 scores on a scale
Standard Deviation 2.08
|
2.53 scores on a scale
Standard Deviation 1.98
|
|
Brief Pain Inventory (BPI) Change From Baseline to After Double Blind Period
Average pain intensity in 24 hrs
|
3.39 scores on a scale
Standard Deviation 1.80
|
3.35 scores on a scale
Standard Deviation 1.73
|
|
Brief Pain Inventory (BPI) Change From Baseline to After Double Blind Period
Current Pain intensity
|
3.78 scores on a scale
Standard Deviation 1.94
|
3.70 scores on a scale
Standard Deviation 1.88
|
SECONDARY outcome
Timeframe: Within 8 days after baselinethe times of breakthrough pain occurrence during double blind treatment phase between the two treatment groups
Outcome measures
| Measure |
Oxycodone Capsules for Cancer Pain
n=120 Participants
Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
|
Morphine Tablets for Cancer Pain
n=118 Participants
Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours
|
|---|---|---|
|
Times of Breakthrough Pain Occurrence
|
15 breakthrough pain events
|
20 breakthrough pain events
|
SECONDARY outcome
Timeframe: baseline up to 19-22 days (open label treatment)the number of patients of satisfaction for pain management between the two treatment groups at the end of double blind treatment and the open label treatment period.
Outcome measures
| Measure |
Oxycodone Capsules for Cancer Pain
n=120 Participants
Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
|
Morphine Tablets for Cancer Pain
n=118 Participants
Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours
|
|---|---|---|
|
Patient Assessments of Satisfaction for Pain Management
Very satisfied
|
35 Participants
|
37 Participants
|
|
Patient Assessments of Satisfaction for Pain Management
Satisfied
|
64 Participants
|
61 Participants
|
|
Patient Assessments of Satisfaction for Pain Management
Neutral
|
9 Participants
|
5 Participants
|
|
Patient Assessments of Satisfaction for Pain Management
Dissatisfied
|
1 Participants
|
4 Participants
|
|
Patient Assessments of Satisfaction for Pain Management
Missing
|
11 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: baseline up to 1-3 days(double blind period)Population: Dosing change frequency for complete titration
the average times to change the dose in order to find the proper dose between two treatment groups
Outcome measures
| Measure |
Oxycodone Capsules for Cancer Pain
n=120 Participants
Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
|
Morphine Tablets for Cancer Pain
n=118 Participants
Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours
|
|---|---|---|
|
Average Number of Titrations
|
8.25 dose changes
Standard Deviation 4.52
|
7.89 dose changes
Standard Deviation 3.43
|
SECONDARY outcome
Timeframe: baseline up to 19-22 days (open label treatment)The secondary outcome measurement is the change of BPI score from baseline to the end of open label treatment between the two treatment groups. The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. This tool measures the worst/least pain in passed 24 hours, and the average/current pain in last 24 hours. The scale is numerically from 0 to 10. 0 means not painful, 10 means extremely painful. The BPI is the average number of above 4 BPI Pain Items.
Outcome measures
| Measure |
Oxycodone Capsules for Cancer Pain
n=120 Participants
Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
|
Morphine Tablets for Cancer Pain
n=118 Participants
Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours
|
|---|---|---|
|
Brief Pain Inventory (BPI) Change From Baseline to Open Label Treatment
Highest pain intensity in 24 hrs
|
3.98 scores on a scale
Standard Deviation 2.09
|
3.95 scores on a scale
Standard Deviation 1.92
|
|
Brief Pain Inventory (BPI) Change From Baseline to Open Label Treatment
Lowest pain intensity in 24 hrs
|
2.57 scores on a scale
Standard Deviation 2.05
|
2.64 scores on a scale
Standard Deviation 1.98
|
|
Brief Pain Inventory (BPI) Change From Baseline to Open Label Treatment
Average pain intensity in 24 hrs
|
3.33 scores on a scale
Standard Deviation 1.83
|
3.48 scores on a scale
Standard Deviation 1.57
|
|
Brief Pain Inventory (BPI) Change From Baseline to Open Label Treatment
Current Pain intensity
|
3.62 scores on a scale
Standard Deviation 1.87
|
3.71 scores on a scale
Standard Deviation 1.57
|
SECONDARY outcome
Timeframe: baseline up to 22 days (double blind period)Population: The double-blind titration period was the dose adjusting phase, so breakthrough pain occurrences in this period were not included in statistical analysis. After titration was completed, subjects entered into maintenance treatment with the titrated dose.
the total dose of rescue medicine for breakthrough pain during double blind phase between the two treatment groups
Outcome measures
| Measure |
Oxycodone Capsules for Cancer Pain
n=120 Participants
Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
|
Morphine Tablets for Cancer Pain
n=118 Participants
Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours
|
|---|---|---|
|
the Total Dose of Rescue Medicine for Breakthrough Pain.
the total dose of rescue medicine -day1
|
10.63 mg
Standard Deviation 7.76
|
7.00 mg
Standard Deviation 4.83
|
|
the Total Dose of Rescue Medicine for Breakthrough Pain.
the total dose of rescue medicine -day2
|
10.00 mg
Standard Deviation 8.29
|
6.00 mg
Standard Deviation 2.07
|
|
the Total Dose of Rescue Medicine for Breakthrough Pain.
the total dose of rescue medicine-day3
|
10.63 mg
Standard Deviation 8.21
|
6.82 mg
Standard Deviation 2.52
|
|
the Total Dose of Rescue Medicine for Breakthrough Pain.
the total dose of rescue medicine-day4
|
20.00 mg
Standard Deviation 8.94
|
7.86 mg
Standard Deviation 3.93
|
|
the Total Dose of Rescue Medicine for Breakthrough Pain.
the total dose of rescue medicine-day5
|
11.00 mg
Standard Deviation 10.84
|
6.67 mg
Standard Deviation 4.08
|
|
the Total Dose of Rescue Medicine for Breakthrough Pain.
the total dose of rescue medicine -day6
|
0 mg
Standard Deviation 0
|
5.00 mg
Standard Deviation 0.00
|
|
the Total Dose of Rescue Medicine for Breakthrough Pain.
the total dose of rescue medicine after day6
|
5.00 mg
Standard Deviation 0
|
5.00 mg
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: baseline up to 5-8 days (double blind period)Brief Pain Inventory (BPI) Change From Baseline to After Double Blind Period. The BPI is the average number of above 4 BPI Pain Items. For the degree of pain relief within 24hrs after treatment, 0 means zero relief and 100 means completely relief with unit of percentage(%).
Outcome measures
| Measure |
Oxycodone Capsules for Cancer Pain
n=120 Participants
Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
|
Morphine Tablets for Cancer Pain
n=118 Participants
Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours
|
|---|---|---|
|
Degree of Pain Relief Within 24hrs After Treatment
|
35.23 percentage of pain relief
Standard Deviation 28.27
|
34.19 percentage of pain relief
Standard Deviation 30.85
|
SECONDARY outcome
Timeframe: baseline up to 19-22 days (open label treatment)For the degree of pain relief within 24hrs after treatment, 0 means zero relief and 100 means completely relief with unit of percentage(%).
Outcome measures
| Measure |
Oxycodone Capsules for Cancer Pain
n=120 Participants
Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
|
Morphine Tablets for Cancer Pain
n=118 Participants
Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours
|
|---|---|---|
|
Brief Pain Inventory (BPI) Change From Baseline to Open Label Treatment
|
32.31 percentage of pain relief
Standard Deviation 30.80
|
31.64 percentage of pain relief
Standard Deviation 29.73
|
Adverse Events
Oxycodone Capsules for Cancer Pain
Serious events: 4 serious events
Other events: 76 other events
Deaths: 2 deaths
Morphine Tablets for Cancer Pain
Serious events: 2 serious events
Other events: 75 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Oxycodone Capsules for Cancer Pain
n=120 participants at risk
Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
|
Morphine Tablets for Cancer Pain
n=118 participants at risk
Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory and circulatory failure
|
1.7%
2/120 • Number of events 2 • up to 36 days
The AE collection period including maximally 7 days screening and 5 to 8 days double blind period, and then 14 days open treatment period. 7 days safety follow up.
|
1.7%
2/118 • Number of events 2 • up to 36 days
The AE collection period including maximally 7 days screening and 5 to 8 days double blind period, and then 14 days open treatment period. 7 days safety follow up.
|
|
Gastrointestinal disorders
ileus
|
0.83%
1/120 • Number of events 1 • up to 36 days
The AE collection period including maximally 7 days screening and 5 to 8 days double blind period, and then 14 days open treatment period. 7 days safety follow up.
|
0.00%
0/118 • up to 36 days
The AE collection period including maximally 7 days screening and 5 to 8 days double blind period, and then 14 days open treatment period. 7 days safety follow up.
|
|
Nervous system disorders
Brain metastases
|
0.83%
1/120 • Number of events 1 • up to 36 days
The AE collection period including maximally 7 days screening and 5 to 8 days double blind period, and then 14 days open treatment period. 7 days safety follow up.
|
0.00%
0/118 • up to 36 days
The AE collection period including maximally 7 days screening and 5 to 8 days double blind period, and then 14 days open treatment period. 7 days safety follow up.
|
Other adverse events
| Measure |
Oxycodone Capsules for Cancer Pain
n=120 participants at risk
Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
|
Morphine Tablets for Cancer Pain
n=118 participants at risk
Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
31.7%
38/120 • Number of events 41 • up to 36 days
The AE collection period including maximally 7 days screening and 5 to 8 days double blind period, and then 14 days open treatment period. 7 days safety follow up.
|
36.4%
43/118 • Number of events 47 • up to 36 days
The AE collection period including maximally 7 days screening and 5 to 8 days double blind period, and then 14 days open treatment period. 7 days safety follow up.
|
|
Gastrointestinal disorders
Nausea
|
20.8%
25/120 • Number of events 31 • up to 36 days
The AE collection period including maximally 7 days screening and 5 to 8 days double blind period, and then 14 days open treatment period. 7 days safety follow up.
|
22.0%
26/118 • Number of events 30 • up to 36 days
The AE collection period including maximally 7 days screening and 5 to 8 days double blind period, and then 14 days open treatment period. 7 days safety follow up.
|
|
Gastrointestinal disorders
Vomiting
|
20.8%
25/120 • Number of events 27 • up to 36 days
The AE collection period including maximally 7 days screening and 5 to 8 days double blind period, and then 14 days open treatment period. 7 days safety follow up.
|
20.3%
24/118 • Number of events 25 • up to 36 days
The AE collection period including maximally 7 days screening and 5 to 8 days double blind period, and then 14 days open treatment period. 7 days safety follow up.
|
|
Nervous system disorders
Dizziness
|
7.5%
9/120 • Number of events 10 • up to 36 days
The AE collection period including maximally 7 days screening and 5 to 8 days double blind period, and then 14 days open treatment period. 7 days safety follow up.
|
5.1%
6/118 • Number of events 6 • up to 36 days
The AE collection period including maximally 7 days screening and 5 to 8 days double blind period, and then 14 days open treatment period. 7 days safety follow up.
|
|
Immune system disorders
Fever
|
6.7%
8/120 • Number of events 9 • up to 36 days
The AE collection period including maximally 7 days screening and 5 to 8 days double blind period, and then 14 days open treatment period. 7 days safety follow up.
|
3.4%
4/118 • Number of events 6 • up to 36 days
The AE collection period including maximally 7 days screening and 5 to 8 days double blind period, and then 14 days open treatment period. 7 days safety follow up.
|
|
Nervous system disorders
Drowsiness
|
6.7%
8/120 • Number of events 8 • up to 36 days
The AE collection period including maximally 7 days screening and 5 to 8 days double blind period, and then 14 days open treatment period. 7 days safety follow up.
|
3.4%
4/118 • Number of events 4 • up to 36 days
The AE collection period including maximally 7 days screening and 5 to 8 days double blind period, and then 14 days open treatment period. 7 days safety follow up.
|
|
Nervous system disorders
Loss of appetite
|
4.2%
5/120 • Number of events 5 • up to 36 days
The AE collection period including maximally 7 days screening and 5 to 8 days double blind period, and then 14 days open treatment period. 7 days safety follow up.
|
2.5%
3/118 • Number of events 3 • up to 36 days
The AE collection period including maximally 7 days screening and 5 to 8 days double blind period, and then 14 days open treatment period. 7 days safety follow up.
|
|
Psychiatric disorders
Fatigue
|
3.3%
4/120 • Number of events 4 • up to 36 days
The AE collection period including maximally 7 days screening and 5 to 8 days double blind period, and then 14 days open treatment period. 7 days safety follow up.
|
1.7%
2/118 • Number of events 2 • up to 36 days
The AE collection period including maximally 7 days screening and 5 to 8 days double blind period, and then 14 days open treatment period. 7 days safety follow up.
|
|
Gastrointestinal disorders
Diarrhea
|
3.3%
4/120 • Number of events 4 • up to 36 days
The AE collection period including maximally 7 days screening and 5 to 8 days double blind period, and then 14 days open treatment period. 7 days safety follow up.
|
1.7%
2/118 • Number of events 2 • up to 36 days
The AE collection period including maximally 7 days screening and 5 to 8 days double blind period, and then 14 days open treatment period. 7 days safety follow up.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
4/120 • Number of events 4 • up to 36 days
The AE collection period including maximally 7 days screening and 5 to 8 days double blind period, and then 14 days open treatment period. 7 days safety follow up.
|
3.4%
4/118 • Number of events 4 • up to 36 days
The AE collection period including maximally 7 days screening and 5 to 8 days double blind period, and then 14 days open treatment period. 7 days safety follow up.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infection
|
2.5%
3/120 • Number of events 3 • up to 36 days
The AE collection period including maximally 7 days screening and 5 to 8 days double blind period, and then 14 days open treatment period. 7 days safety follow up.
|
3.4%
4/118 • Number of events 4 • up to 36 days
The AE collection period including maximally 7 days screening and 5 to 8 days double blind period, and then 14 days open treatment period. 7 days safety follow up.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.5%
3/120 • Number of events 3 • up to 36 days
The AE collection period including maximally 7 days screening and 5 to 8 days double blind period, and then 14 days open treatment period. 7 days safety follow up.
|
0.85%
1/118 • Number of events 1 • up to 36 days
The AE collection period including maximally 7 days screening and 5 to 8 days double blind period, and then 14 days open treatment period. 7 days safety follow up.
|
|
Renal and urinary disorders
Dysuria
|
2.5%
3/120 • Number of events 3 • up to 36 days
The AE collection period including maximally 7 days screening and 5 to 8 days double blind period, and then 14 days open treatment period. 7 days safety follow up.
|
5.1%
6/118 • Number of events 6 • up to 36 days
The AE collection period including maximally 7 days screening and 5 to 8 days double blind period, and then 14 days open treatment period. 7 days safety follow up.
|
|
Blood and lymphatic system disorders
Anemia
|
2.5%
3/120 • Number of events 3 • up to 36 days
The AE collection period including maximally 7 days screening and 5 to 8 days double blind period, and then 14 days open treatment period. 7 days safety follow up.
|
0.85%
1/118 • Number of events 1 • up to 36 days
The AE collection period including maximally 7 days screening and 5 to 8 days double blind period, and then 14 days open treatment period. 7 days safety follow up.
|
|
Blood and lymphatic system disorders
Low platelet count
|
2.5%
3/120 • Number of events 3 • up to 36 days
The AE collection period including maximally 7 days screening and 5 to 8 days double blind period, and then 14 days open treatment period. 7 days safety follow up.
|
0.00%
0/118 • up to 36 days
The AE collection period including maximally 7 days screening and 5 to 8 days double blind period, and then 14 days open treatment period. 7 days safety follow up.
|
|
Blood and lymphatic system disorders
Hypertension
|
2.5%
3/120 • Number of events 3 • up to 36 days
The AE collection period including maximally 7 days screening and 5 to 8 days double blind period, and then 14 days open treatment period. 7 days safety follow up.
|
0.85%
1/118 • Number of events 1 • up to 36 days
The AE collection period including maximally 7 days screening and 5 to 8 days double blind period, and then 14 days open treatment period. 7 days safety follow up.
|
Additional Information
Director of R&D
Mundipharma (China) phamaceutical CO. LTD
Phone: 0086-10-65636800
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place