Trial · NCT01165281
A Safety and Efficacy Study of JNS024 Extended Release (ER) in Japanese and Korean Patients With Chronic Malignant Tumor-Related Cancer Pain
NCT01165281, Phase 3, Completed, Janssen Research & Development, LLC; results first posted 2014-01-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Safety and Efficacy Study of JNS024 Extended Release (ER) in Japanese and Korean Patients With Chronic Malignant Tumor-Related Cancer Pain. Trials, record NCT01165281. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01165281
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety and Efficacy Study of JNS024 Extended Release (ER) in Japanese and Korean Patients With Chronic Malignant Tumor-Related Cancer Pain
- NCT number
- NCT01165281
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 343 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Pain
- Interventions
- Oxycodone CR, R331333 (referred to as JNS024 ER or CG5503)
- First posted
- 2010-07-19
- Last updated
- 2017-07-21
- Results first posted
- 2014-01-15
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to the Last 3 Days of Study Drug Administration (Last Observation Carried Forward) in the Score for Average Pain Intensity on an 11-point Numerical Rating Scale | Baseline, Last 3 Days of Study Drug Administration (4 weeks) | The patients recorded their average pain intensity over the past 24 hours once daily in the evening and at the same time as much as possible (eg, 10:00 PM) throughout the study in response to the following question: "What has your average pain level been for the past 24 hours, where 0=no pain and 10=pain as bad as you can imagine." The score at 3 days before the completion of study drug administration was defined as the average pain intensity score averaged over the last 3 days before completion of study drug administration. |
| Secondary | Percentage of Patients in Patient Global Impression of Change (PGIC) Score Categories | Baseline, Endpoint of the 4-week Treatment Period | The PGIC was rated by the patient and was based on the single question "Since the start of this treatment, my cancer-related pain overall is," where 1=very much improved, 2=much improved, 3=minimally improved, 4=not changed, 5=minimally worse, 6=much worse, 7=very much worse. |
| Secondary | Frequency of Rescue Medication Use for the Double-blind Treatment Period | 4 weeks | During the study, if a patient experienced breakthrough pain (pain that occurs for short periods of time between doses of study drug), treatment with rescue medication (morphine immediate release \[IR\] 5 mg) was to be given. The average number of doses of Morphine IR taken per day was assessed. |
| Secondary | Total Daily Dose of Rescue Medication Use for the Double-blind Treatment Period | 4 weeks | During the study, if a patient experienced breakthrough pain (pain that occurs for short periods of time between doses of study drug), treatment with rescue medication (morphine immediate release \[IR\] 5 mg) was to be given. The average total daily dose of Morphine IR taken (mg) was assessed. |
| Secondary | Proportion of Patients With Various Levels of Pain Improvement (Responders) | Baseline, Last 3 Days of Study Drug Administration (4 weeks) | The proportion of patients with at least a 30 percentage improvement based on the percent change from baseline in Numerical Rating Scale score during the last 3 days of the double-blind treatment period. |
| Secondary | Proportion of Patients Entering the Maintenance Period | 4 weeks | Patients were eligible to formally enter the maintenance period if they had a pain intensity score of \<=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. |
| Secondary | Number of Patients Who Discontinued Due to Lack of Efficacy | 4 weeks | The duration from the date of first study drug intake to treatment discontinuation due to lack of efficacy. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to the Last 3 Days of Study Drug Administration (Last Observation Carried Forward) in the Score for Average Pain Intensity on an 11-point Numerical Rating Scale | Baseline, Last 3 Days of Study Drug Administration (4 weeks) | Per-protocol population included all patients who were randomized, received at least 1 dose of study drug, had post-baseline efficacy data and didn't have major protocol deviations (including use of prohibited concomitant medications, non-compliance, failure to meet selection criteria, violation of regulatory requirements, or treatment deviation). | Scores on scale | MEAN |
| SECONDARY | Percentage of Patients in Patient Global Impression of Change (PGIC) Score Categories | Baseline, Endpoint of the 4-week Treatment Period | Per-protocol population included all patients who were randomized, received at least 1 dose of study drug, had post-baseline efficacy data and didn't have major protocol deviations (including use of prohibited concomitant medications, non-compliance, failure to meet selection criteria, violation of regulatory requirements, or treatment deviation). | Percentage of Participants | NUMBER |
| SECONDARY | Frequency of Rescue Medication Use for the Double-blind Treatment Period | 4 weeks | This is a subset of the per-protocol population that included patients who received at least 1 dose of rescue medication. The per-protocol population included all patients who were randomized, received at least 1 dose of study drug, had post-baseline efficacy data and didn't have major protocol deviations. | Number of doses per day | MEAN |
| SECONDARY | Total Daily Dose of Rescue Medication Use for the Double-blind Treatment Period | 4 weeks | This is a subset of the per-protocol population that included patients who received at least 1 dose of rescue medication. The per-protocol population included all patients who were randomized, received at least 1 dose of study drug, had post-baseline efficacy data and didn't have major protocol deviations. | Milligrams | MEAN |
| SECONDARY | Proportion of Patients With Various Levels of Pain Improvement (Responders) | Baseline, Last 3 Days of Study Drug Administration (4 weeks) | Per-protocol population included all patients who were randomized, received at least 1 dose of study drug, had post-baseline efficacy data and didn't have major protocol deviations (including use of prohibited concomitant medications, non-compliance, failure to meet selection criteria, violation of regulatory requirements, or treatment deviation). | Percentage of Participants | NUMBER |
| SECONDARY | Proportion of Patients Entering the Maintenance Period | 4 weeks | Per-protocol population included all patients who were randomized, received at least 1 dose of study drug, had post-baseline efficacy data and didn't have major protocol deviations (including use of prohibited concomitant medications, non-compliance, failure to meet selection criteria, violation of regulatory requirements, or treatment deviation). | Percentage of Participants | NUMBER |
| SECONDARY | Number of Patients Who Discontinued Due to Lack of Efficacy | 4 weeks | Time to discontinuation due to lack of efficacy was not analyzed since there was only 1 patient in the per-protocol set (in the tapentadol group) who discontinued treatment due to lack of efficacy. | Number of participants | NUMBER |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to the Last 3 Days of Study Drug Administration (Last Observation Carried Forward) in the Score for Average Pain Intensity on an 11-point Numerical Rating Scale | Tapentadol (JNS024) Extended-release (ER) Oral Tablets | -2.69 | Standard Deviation 2.223 | Scores on scale | |
| Change From Baseline to the Last 3 Days of Study Drug Administration (Last Observation Carried Forward) in the Score for Average Pain Intensity on an 11-point Numerical Rating Scale | Oxycodone Controlled-release (CR) Oral Tablets | -2.57 | Standard Deviation 2.027 | Scores on scale | |
| Percentage of Patients in Patient Global Impression of Change (PGIC) Score Categories | Tapentadol (JNS024) Extended-release (ER) Oral Tablets | Percentage much improved or very much improved | 58.7 | Percentage of Participants | |
| Percentage of Patients in Patient Global Impression of Change (PGIC) Score Categories | Oxycodone Controlled-release (CR) Oral Tablets | Percentage much improved or very much improved | 50.4 | Percentage of Participants | |
| Percentage of Patients in Patient Global Impression of Change (PGIC) Score Categories | Tapentadol (JNS024) Extended-release (ER) Oral Tablets | Percentage much worse or very much worse | 4.0 | Percentage of Participants | |
| Percentage of Patients in Patient Global Impression of Change (PGIC) Score Categories | Oxycodone Controlled-release (CR) Oral Tablets | Percentage much worse or very much worse | 1.4 | Percentage of Participants | |
| Frequency of Rescue Medication Use for the Double-blind Treatment Period | Tapentadol (JNS024) Extended-release (ER) Oral Tablets | 1.39 | Standard Deviation 0.460 | Number of doses per day | |
| Frequency of Rescue Medication Use for the Double-blind Treatment Period | Oxycodone Controlled-release (CR) Oral Tablets | 1.35 | Standard Deviation 0.431 | Number of doses per day | |
| Total Daily Dose of Rescue Medication Use for the Double-blind Treatment Period | Tapentadol (JNS024) Extended-release (ER) Oral Tablets | 6.95 | Standard Deviation 2.302 | Milligrams | |
| Total Daily Dose of Rescue Medication Use for the Double-blind Treatment Period | Oxycodone Controlled-release (CR) Oral Tablets | 6.73 | Standard Deviation 2.153 | Milligrams |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tapentadol (JNS024) Extended-release (ER) Oral Tablets | 168 | |
| Overall Study | STARTED | Oxycodone Controlled-release (CR) Oral Tablets | 172 | |
| Overall Study | COMPLETED | Tapentadol (JNS024) Extended-release (ER) Oral Tablets | 110 | |
| Overall Study | COMPLETED | Oxycodone Controlled-release (CR) Oral Tablets | 121 | |
| Overall Study | NOT COMPLETED | Tapentadol (JNS024) Extended-release (ER) Oral Tablets | 58 | |
| Overall Study | NOT COMPLETED | Oxycodone Controlled-release (CR) Oral Tablets | 51 |
Source ClinicalTrials.gov
Adverse events166
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Tapentadol (JNS024) Extended-release (ER) Oral Tablets | 4 | 168 | |
| other | Anaemia | Blood and lymphatic system disorders | Oxycodone Controlled-release (CR) Oral Tablets | 11 | 172 | |
| other | Constipation | Gastrointestinal disorders | Tapentadol (JNS024) Extended-release (ER) Oral Tablets | 51 | 168 | |
| other | Constipation | Gastrointestinal disorders | Oxycodone Controlled-release (CR) Oral Tablets | 64 | 172 | |
| other | Diarrhoea | Gastrointestinal disorders | Tapentadol (JNS024) Extended-release (ER) Oral Tablets | 9 | 168 | |
| other | Diarrhoea | Gastrointestinal disorders | Oxycodone Controlled-release (CR) Oral Tablets | 19 | 172 | |
| other | Nausea | Gastrointestinal disorders | Tapentadol (JNS024) Extended-release (ER) Oral Tablets | 48 | 168 | |
| other | Nausea | Gastrointestinal disorders | Oxycodone Controlled-release (CR) Oral Tablets | 61 | 172 | |
| other | Vomiting | Gastrointestinal disorders | Tapentadol (JNS024) Extended-release (ER) Oral Tablets | 41 | 168 | |
| other | Vomiting | Gastrointestinal disorders | Oxycodone Controlled-release (CR) Oral Tablets | 41 | 172 |
1 to 10 of 166Source ClinicalTrials.gov
See all 166 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tapentadol (JNS024) Extended-release (ER) Oral Tablets | ||
| Total, all-cause mortality | Oxycodone Controlled-release (CR) Oral Tablets | ||
| Total, other adverse events | Tapentadol (JNS024) Extended-release (ER) Oral Tablets | 110 | 168 |
| Total, other adverse events | Oxycodone Controlled-release (CR) Oral Tablets | 127 | 172 |
| Total, serious adverse events | Tapentadol (JNS024) Extended-release (ER) Oral Tablets | 78 | 168 |
| Total, serious adverse events | Oxycodone Controlled-release (CR) Oral Tablets | 69 | 172 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23937387 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Tapentadol (JNS024) Extended-release (ER) Oral Tablets vs Oxycodone Controlled-release (CR) Oral Tablets: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01165281
GET https://conductscience.org/api/trials/v1/NCT01165281/events?page=2