Trial · NCT01309386
A Safety and Efficacy Study of Oral Tapentadol Extended-Release in Japanese Participants
NCT01309386, Phase 3, Completed, Janssen Pharmaceutical K.K.; results first posted 2013-03-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Safety and Efficacy Study of Oral Tapentadol Extended-Release in Japanese Participants. Trials, record NCT01309386. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01309386
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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 Oral Tapentadol Extended-Release in Japanese Participants
- NCT number
- NCT01309386
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 100 participants, actual
- Lead sponsor
- Janssen Pharmaceutical K.K.
- Conditions
- Neoplasms
- Interventions
- Tapentadol ER, Morphine SR
- First posted
- 2011-03-07
- Last updated
- 2013-03-13
- Results first posted
- 2013-03-13
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieved Pain Control | Week 1 | Pain control was considered to be achieved for participants who met both of the following criteria for any consecutive 3 days during the first week of treatment period: a) Change from baseline of mean 24 hour numerical rating scale (NRS) (an 11-point NRS is used to measure the pain level where 0=no pain to 10=pain as bad as you can imagine) score less than +1.5, and b) when the frequency of rescue medication was twice or less per day. |
| Secondary | Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8 | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8 | Average pain intensity was assessed using an 11-point NRS to measure the pain level for the past 24-hours where 0=no pain to 10=pain as bad as you can imagine. |
| Secondary | Number of Participants Who Discontinued Study Treatment Due to Lack of Efficacy | Baseline up to Week 8 | Number of participants who discontinued the treatment due to lack of efficacy were assessed throughout the study. |
| Secondary | Number of Participants With Patient Global Impression of Change (PGIC) | Week 1, 4 and 8 | The PGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the participant's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of "very much improved" or "much improved". |
| Secondary | Total Number of Days of Rescue Medication Over Time | Baseline up to Week 8 | Total number of days of rescue medication over time were assessed. Rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. Supplemental analgesics (drug used to control pain) were used as rescue medication. |
| Secondary | Number of Doses of Rescue Medication Over Time | Baseline up to Week 8 | Number of doses of rescue medication over time were assessed. Rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. Supplemental analgesics (drug used to control pain) were used as rescue medication. |
| Secondary | Average Change From Baseline in Amount of Rescue Medication Over Time | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8 | Rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. Supplemental analgesics (drug used to control pain) were used as rescue medication. Average amount was the averages of all doses recorded during the baseline period or during each week (Week 1, 2, 3, 4, 5, 6, 7 and 8). |
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 | Percentage of Participants Who Achieved Pain Control | Week 1 | Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data. | Percentage of Participants | NUMBER |
| SECONDARY | Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8 | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8 | Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data. Here 'n' signifies those participants evaluable for this measure at the specified time point for each arm group, respectively. | Unit on scale | MEAN |
| SECONDARY | Number of Participants Who Discontinued Study Treatment Due to Lack of Efficacy | Baseline up to Week 8 | Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data. | Participants | NUMBER |
| SECONDARY | Number of Participants With Patient Global Impression of Change (PGIC) | Week 1, 4 and 8 | Full analysis set (FAS) population; here 'N' signifies those participants evaluable for this outcome measure and 'n' signifies those participants evaluable for this measure at the specified time point for each arm group, respectively. | Participants | NUMBER |
| SECONDARY | Total Number of Days of Rescue Medication Over Time | Baseline up to Week 8 | Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data. | Days | MEAN |
| SECONDARY | Number of Doses of Rescue Medication Over Time | Baseline up to Week 8 | Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data. | Morphine-equivalent doses | MEAN |
| SECONDARY | Average Change From Baseline in Amount of Rescue Medication Over Time | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8 | Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data. | Milligram (mg) | MEAN |
Source ClinicalTrials.gov
Results by group68
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Achieved Pain Control | Tapentadol ER | 84.0 | 95% Confidence Interval 70.89 to 92.83 | Percentage of Participants | |
| Percentage of Participants Who Achieved Pain Control | Morphine SR | 98.0 | 95% Confidence Interval 89.35 to 99.95 | Percentage of Participants | |
| Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8 | Tapentadol ER | Change at Week 1 (n = 50, 50) | 0.4 | Standard Deviation 0.92 | Unit on scale |
| Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8 | Morphine SR | Change at Week 1 (n = 50, 50) | -0.2 | Standard Deviation 0.84 | Unit on scale |
| Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8 | Tapentadol ER | Change at Week 2 (n = 45, 44) | 0.3 | Standard Deviation 1.11 | Unit on scale |
| Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8 | Morphine SR | Change at Week 2 (n = 45, 44) | -0.3 | Standard Deviation 0.75 | Unit on scale |
| Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8 | Tapentadol ER | Change at Week 3 (n= 41, 41) | 0.1 | Standard Deviation 0.90 | Unit on scale |
| Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8 | Morphine SR | Change at Week 3 (n= 41, 41) | -0.1 | Standard Deviation 1.03 | Unit on scale |
| Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8 | Tapentadol ER | Change at Week 4 (n = 38, 37) | 0.1 | Standard Deviation 0.90 | Unit on scale |
| Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8 | Morphine SR | Change at Week 4 (n = 38, 37) | -0.3 | Standard Deviation 0.95 | Unit on scale |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 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 ER | 50 | |
| Overall Study | STARTED | Morphine SR | 50 | |
| Overall Study | COMPLETED | Tapentadol ER | 28 | |
| Overall Study | COMPLETED | Morphine SR | 29 | |
| Overall Study | NOT COMPLETED | Tapentadol ER | 22 | |
| Overall Study | NOT COMPLETED | Morphine SR | 21 |
Source ClinicalTrials.gov
Adverse events256
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 | Nasopharyngitis | Infections and infestations | Tapentadol ER | 1 | 50 | |
| other | Nasopharyngitis | Infections and infestations | Morphine SR | 1 | 50 | |
| other | Pneumonia | Infections and infestations | Tapentadol ER | 1 | 50 | |
| other | Pneumonia | Infections and infestations | Morphine SR | 1 | 50 | |
| other | Bacteraemia | Infections and infestations | Tapentadol ER | 0 | 50 | |
| other | Bacteraemia | Infections and infestations | Morphine SR | 1 | 50 | |
| other | Cellulitis | Infections and infestations | Tapentadol ER | 0 | 50 | |
| other | Cellulitis | Infections and infestations | Morphine SR | 1 | 50 | |
| other | Oral candidiasis | Infections and infestations | Tapentadol ER | 1 | 50 | |
| other | Oral candidiasis | Infections and infestations | Morphine SR | 0 | 50 |
1 to 10 of 256Source ClinicalTrials.gov
See all 256 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tapentadol ER | ||
| Total, all-cause mortality | Morphine SR | ||
| Total, other adverse events | Tapentadol ER | 43 | 50 |
| Total, other adverse events | Morphine SR | 44 | 50 |
| Total, serious adverse events | Tapentadol ER | 16 | 50 |
| Total, serious adverse events | Morphine SR | 16 | 50 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24906437 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tapentadol ER vs Morphine SR: Number of Participants Who Discontinued Study Treatment Due to Lack of Efficacy | Trial comparisons |
| Tapentadol ER vs Morphine SR: serious adverse events | 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/NCT01309386
GET https://conductscience.org/api/trials/v1/NCT01309386/results?page=2