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| ID | Type | Description | Link |
|---|---|---|---|
| JNS024PR-JPN-C01 |
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| Name | Class |
|---|---|
| Grünenthal GmbH | INDUSTRY |
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The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time; explores what the body does to the drug) of tapentadol prolonged release (JNS024PR, PR) in participants with moderate to severe cancer (abnormal tissue that grows and spreads in the body until it kills) pain.
This is a Phase 2 open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center), non-comparative, optional dose-titration study of tapentadol PR in Japanese participants with cancer pain. This study will consist of Screening period (3 to 7 days), Dose adjustment period (3 to 14 days), Fixed dose period (5 days) and Follow-up period (7 days). Tapentadol PR will be administered orally (taken by mouth; to be swallowed) twice daily before meal. For participants previously using opioids, the initial dose of tapentadol PR will be selected depending on the daily dose of opioid at the completion of Screening period. For opioid-naive (moderate to severe cancer pain that is not controlled adequately with non-opioid medications) participants, the initial dose of tapentadol PR will be 25 milligram (mg) twice daily. Participants will receive the same dose of tapentadol PR for the first 2 days of the dose adjustment period and from Day 3, the dose can be titrated as per the Investigator's discretion up to Day 14. After that participants will receive fixed dose regimen for 5 days at the same dose as that used at the end of the dose adjustment period. Efficacy will primarily be evaluated by sustained pain control for the 5 day fixed dose phase. Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opioid-Naive Participants (Tapentadol PR) | Experimental | Opioid-naive participants are defined as those who had moderate to severe cancer pain that is not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) is duration between start of treatment to day before initial dose in the maintenance period. Treatment will be initiated with tapentadol prolonged release (JNS024PR, PR) 25 milligram (mg) oral tablet twice daily. Dose will be increased or decreased as per Investigator's discretion up to Day 14. Maximum dose limit will be 500 mg per day. Participants will then be assigned to the treatment in the maintenance period (15-19 days). The maintenance period is duration between the first dose and the final assessment in the maintenance period. Participants will receive tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period. |
|
| Opioid-Switch Participants (Tapentadol PR) | Experimental | Opioid-switching participants are defined as those who had moderate to severe cancer pain that is controlled sufficiently with opioid therapy. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) is duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR is selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily is given depending on daily dose of opioid at completion of Screening period. Maximum dose limit is 500 mg per day. Participants will then be assigned to treatment in maintenance period (15-19 days). Maintenance period is defined as duration between first dose and final assessment in maintenance period. Participants will receive tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tapentadol PR | Drug | Tapentadol PR tablets will be administered orally twice daily initiated at dose of 25 mg. Dose will be adjusted as per Investigator's discretion. Maximum dose limit is 500 mg per day. Total duration of treatment is 19 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Pain Control for 5 Day Fixed Dose Phase | Percentage of participants with sustained pain control for 5 day fixed dose phase were the participants who completed 5 day maintenance period, whose mean Numerical Rating Scale (NRS) score during the fixed dose phase and which was assessed immediately before giving each dose was less than 4 and the number of rescue doses per day for fixed dose phase was 2 or less. Pain intensity scores were recorded 0 to 30 minutes before dose on 11 point NRS where 0 = no pain and 10 = severest pain imaginable. | Day 15 up to Day 19 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieve Dose Adjustment | Percentage of participants who achieved dose adjustment included those participants whose dose was adjusted during the titration period period and entered the fixed dose maintenance period. Titration period (3-14 days) was the duration between start of treatment to the day before the initial dose in the maintenance period. Maintenance period (15-19 days) was the duration between the first dose and the final assessment in the maintenance period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K., Japan Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chiba | Japan | |||||
95 participants signed the informed consent form, of which 78 participants were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Opioid-Naive Participants (Tapentadol PR) | Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (JNS024PR, PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator's discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period. |
| FG001 | Opioid-Switch Participants (Tapentadol PR) | Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Titration Period |
|
| |||||||||||||||||||||
| Maintenance Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Opioid-Naive Participants (Tapentadol PR) | Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator's discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Out of a total of 78 participants, Baseline characteristic (Age) was available for only 66 participants who were included in per protocol (PP) population. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Sustained Pain Control for 5 Day Fixed Dose Phase | Percentage of participants with sustained pain control for 5 day fixed dose phase were the participants who completed 5 day maintenance period, whose mean Numerical Rating Scale (NRS) score during the fixed dose phase and which was assessed immediately before giving each dose was less than 4 and the number of rescue doses per day for fixed dose phase was 2 or less. Pain intensity scores were recorded 0 to 30 minutes before dose on 11 point NRS where 0 = no pain and 10 = severest pain imaginable. | Per protocol set (PPS) included all participants enrolled excluding those with a major protocol violation. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 15 up to Day 19 |
|
Baseline up to 7 days after last dose of study treatment
Safety Population consisted of participants who received at least one dose of study medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Opioid-Naive Participants (Tapentadol PR) | Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator's discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 12.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood pressure increased | Investigations | MedDRA Version 12.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director, Clinical Leader | Janssen R&D, 1125 Trenton-Harbourton Road, Titusville, PA 18902, USA | 609-730-6777 |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077432 | Tapentadol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Day 3 up to Day 14 |
| Pain Assessment Using 24-hour Numerical Rating Scores (NRS) Scale | Pain intensity scores were measured on 11 point NRS, where 0 = no pain and 10 = severest pain imaginable. The pain intensity at Baseline was the average of scores on two consecutive morning doses (Day -1 and Day 0) and on Day 20 only a single observation was recorded. | Baseline (Average of Day -1 and Day 0 morning scores), Day 20 |
| Pain Assessment Using Visual Analog Scale (VAS) Score | Pain VAS assesses the pain intensity experienced by the participant on a 100 millimeter (mm) VAS, where responses range from a response of no pain (score of 0 mm) to severest pain imaginable (score of 100 mm). The participant indicated the pain by marking the applicable place with slash (/) and the investigator then measured the length from left edge to the slash. | Baseline and Day 19 |
| Rescue Doses | The immediate release (IR) oral opioids were used as rescue doses in the participants with lack of efficacy or to have relief from severe pain. In case of opioid-switching participants rescue doses were continued without any change in the preceding doses or the type throughout the study. The IR morphine HCl was used as the rescue dose for opioid-naive participants. The upper limit of rescue doses was specified for each daily dose of tapentadol PR. There was no change in the dose of rescue medication during maintenance period for opioid-naive participants. | Day 12, 13, 14, 15, 16, 17, 18 and 19 |
| Number of Participants Who Discontinued Study Treatment Because of Any Adverse Event (AE) or Lack of Efficacy | The AE is an undesirable or unwanted consequence that occurred during the course of the clinical trial, but not necessarily because of study drug.The AEs included the onset of new symptoms, worsening of the frequency or severity of the symptom compared with Baseline, and abnormal findings including abnormal laboratory test values in the diagnostic examination. The participants who discontinued because of lack of efficacy were those in which satisfactory analgesia was not maintained. | Baseline up to 7 days after last dose of study treatment |
| Sleep Questionnaire Regarding Time to Sleep and Total Time Slept | The sleep questionnaire is a 4-item questionnaire evaluating the condition of the sleep of the participant on the previous night. The participants were asked about the time taken by them to fall asleep previous night after bedtime and the total time they slept during previous night. | Pre-dose (Day 1) and Day 20 |
| Sleep Questionnaire Regarding Number of Awakenings | The sleep questionnaire is a 4-item questionnaire evaluating the condition of the sleep of the participant on the previous night . Participants were asked to provide the number of times they awoke at night. | Pre-dose (Day 1) and Day 20 |
| Sleep Questionnaire Regarding the Quality of Sleep | The sleep questionnaire is a 4-item questionnaire evaluating the condition of the sleep of the participant on the previous night. Participants rated overall sleep quality on a scale ranging from excellent to very poor. | Pre-dose (Day 1) and Day 20 |
| Patient's Global Impression of Change (PGI-C) | PGI-C is a participant rated instrument to measure participant's change in overall status of general condition including pain on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). | Day 19 |
| Chikushino-shi |
| Japan |
| Fukuoka | Japan |
| Himeji | Japan |
| Hirosaki | Japan |
| Ichinomiya | Japan |
| Ikeda | Japan |
| Iwakuni | Japan |
| Kobe | Japan |
| Kochi | Japan |
| Kyoto | Japan |
| Nishinomiya | Japan |
| Ohta | Japan |
| Osaka | Japan |
| Sapporo | Japan |
| Sasebo | Japan |
| Shizuoka | Japan |
| Sonogishukugō | Japan |
| Tokyo | Japan |
| Toyonaka | Japan |
| Utsunomiya | Japan |
| Lost to Follow-up |
|
| Disease Progression |
|
| Withdrawal of consent |
|
| Other |
|
| NOT COMPLETED |
|
|
| BG001 | Opioid-Switch Participants (Tapentadol PR) | Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Out of a total of 78 participants, Baseline characteristic (Gender) was available for only 66 participants who were included in PP population | Count of Participants | Participants |
|
Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled adequately with non-opioid medications. The maintenance period (15-19 days) was the duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol prolonged release (PR) oral tablet twice daily for 5 days at the same dose used on last day of titration period. |
| OG001 | Opioid-Switch Participants Maintenance Period (Tapentadol PR) | Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. The maintenance period (15-19 days) was defined as the duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period. |
|
|
| Secondary | Percentage of Participants Who Achieve Dose Adjustment | Percentage of participants who achieved dose adjustment included those participants whose dose was adjusted during the titration period period and entered the fixed dose maintenance period. Titration period (3-14 days) was the duration between start of treatment to the day before the initial dose in the maintenance period. Maintenance period (15-19 days) was the duration between the first dose and the final assessment in the maintenance period. | The PPS included all participants enrolled excluding those with a major protocol violation. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 3 up to Day 14 |
|
|
|
| Secondary | Pain Assessment Using 24-hour Numerical Rating Scores (NRS) Scale | Pain intensity scores were measured on 11 point NRS, where 0 = no pain and 10 = severest pain imaginable. The pain intensity at Baseline was the average of scores on two consecutive morning doses (Day -1 and Day 0) and on Day 20 only a single observation was recorded. | The PPS included all participants enrolled excluding those with a major protocol violation. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Average of Day -1 and Day 0 morning scores), Day 20 |
|
|
|
| Secondary | Pain Assessment Using Visual Analog Scale (VAS) Score | Pain VAS assesses the pain intensity experienced by the participant on a 100 millimeter (mm) VAS, where responses range from a response of no pain (score of 0 mm) to severest pain imaginable (score of 100 mm). The participant indicated the pain by marking the applicable place with slash (/) and the investigator then measured the length from left edge to the slash. | The PPS included all participants enrolled excluding those with a major protocol violation. Missing values were imputed using last observed carried forward (LOCF) method. | Posted | Mean | Standard Deviation | mm | Baseline and Day 19 |
|
|
|
| Secondary | Rescue Doses | The immediate release (IR) oral opioids were used as rescue doses in the participants with lack of efficacy or to have relief from severe pain. In case of opioid-switching participants rescue doses were continued without any change in the preceding doses or the type throughout the study. The IR morphine HCl was used as the rescue dose for opioid-naive participants. The upper limit of rescue doses was specified for each daily dose of tapentadol PR. There was no change in the dose of rescue medication during maintenance period for opioid-naive participants. | The PPS included all participants enrolled excluding those with a major protocol violation. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure. | Posted | Mean | Standard Deviation | mg per day | Day 12, 13, 14, 15, 16, 17, 18 and 19 |
|
|
|
| Secondary | Number of Participants Who Discontinued Study Treatment Because of Any Adverse Event (AE) or Lack of Efficacy | The AE is an undesirable or unwanted consequence that occurred during the course of the clinical trial, but not necessarily because of study drug.The AEs included the onset of new symptoms, worsening of the frequency or severity of the symptom compared with Baseline, and abnormal findings including abnormal laboratory test values in the diagnostic examination. The participants who discontinued because of lack of efficacy were those in which satisfactory analgesia was not maintained. | The PPS included all participants enrolled excluding those with a major protocol violation. | Posted | Number | participants | Baseline up to 7 days after last dose of study treatment |
|
|
|
| Secondary | Sleep Questionnaire Regarding Time to Sleep and Total Time Slept | The sleep questionnaire is a 4-item questionnaire evaluating the condition of the sleep of the participant on the previous night. The participants were asked about the time taken by them to fall asleep previous night after bedtime and the total time they slept during previous night. | THe PPS included all participants enrolled excluding those with a major protocol violation. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure. | Posted | Mean | Standard Deviation | minutes | Pre-dose (Day 1) and Day 20 |
|
|
|
| Secondary | Sleep Questionnaire Regarding Number of Awakenings | The sleep questionnaire is a 4-item questionnaire evaluating the condition of the sleep of the participant on the previous night . Participants were asked to provide the number of times they awoke at night. | The PPS included all participants enrolled excluding those with a major protocol violation. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure. | Posted | Mean | Standard Deviation | awakenings | Pre-dose (Day 1) and Day 20 |
|
|
|
| Secondary | Sleep Questionnaire Regarding the Quality of Sleep | The sleep questionnaire is a 4-item questionnaire evaluating the condition of the sleep of the participant on the previous night. Participants rated overall sleep quality on a scale ranging from excellent to very poor. | The PPS included all participants enrolled excluding those with a major protocol violation. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure. | Posted | Number | participants | Pre-dose (Day 1) and Day 20 |
|
|
|
| Secondary | Patient's Global Impression of Change (PGI-C) | PGI-C is a participant rated instrument to measure participant's change in overall status of general condition including pain on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). | The PPS included all participants enrolled excluding those with a major protocol violation. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure. | Posted | Number | participants | Day 19 |
|
|
|
| 5 |
| 36 |
| 33 |
| 36 |
| EG001 | Opioid-Switch Participants (Tapentadol PR) | Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period. | 3 | 42 | 29 | 42 |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Gastric neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Bradyarrhythmia | Cardiac disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Respiratory depression | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 12.0 | Non-systematic Assessment |
|
The disclosure restriction on PI is that the Sponsor can review results communications prior to public release and can embargo communications regarding results for a period as the sponsor requires.
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| Day 14 |
|
| Day 15 |
|
| Day 16 |
|
| Day 17 |
|
| Day 18 |
|
| Day 19 |
|
| Total time slept: Pre-dose (Day 1) |
|
| Total time slept: Day 20 |
|
| Good: Pre-dose (Day 1) |
|
| Good: Day 20 |
|
| Fair: Pre-dose (Day 1) |
|
| Fair: Day 20 |
|
| Poor: Pre-dose (Day 1) |
|
| Poor: Day 20 |
|
| Very Poor: Pre-dose (Day 1) |
|
| Very Poor: Day 20 |
|
| Minimally improved |
|
| No change |
|
| Minimally worse |
|
| Worse |
|
| Very much worse |
|