Trial · NCT01124617
A Phase 2 Study of Tapentadol Extended-Release (JNS024ER) ) in Japanese Participants With Chronic Pain Due to Diabetic Neuropathic Pain or Postherpetic Neuralgia
NCT01124617, Phase 2, Completed, Janssen Pharmaceutical K.K.; results first posted 2013-06-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase 2 Study of Tapentadol Extended-Release (JNS024ER) ) in Japanese Participants With Chronic Pain Due to Diabetic Neuropathic Pain or Postherpetic Neuralgia. Trials, record NCT01124617. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01124617
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2 Study of Tapentadol Extended-Release (JNS024ER) ) in Japanese Participants With Chronic Pain Due to Diabetic Neuropathic Pain or Postherpetic Neuralgia
- NCT number
- NCT01124617
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 91 participants, actual
- Lead sponsor
- Janssen Pharmaceutical K.K.
- Conditions
- Pain, Diabetic Neuropathies, Neuralgia, Postherpetic Neuralgia
- Interventions
- Tapentadol, Placebo
- First posted
- 2010-05-17
- Last updated
- 2014-01-13
- Results first posted
- 2013-06-26
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 12 | Baseline and Week 12 | Participants were asked to assess the average pain intensity on an 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number on the scale applicable to their pain. Baseline pain score is defined as the average pain intensity score over the last 3 days prior to the randomization. Change from Baseline in NRS score is the mean NRS score at Week 12 minus mean NRS score at Baseline. |
| Secondary | Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11 | Participants were asked to assess the average pain intensity on an 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number on the scale applicable to their pain. Baseline pain score is defined as the average pain intensity score over the last 3 days prior to the randomization. Change from Baseline in NRS score is the mean NRS score at corresponding week minus mean NRS score at Baseline. |
| Secondary | Percentage of Participants With Treatment Response Based on Numerical Rating Scale (NRS) | Week 12 | Percentage of participants with treatment response in mean NRS score by greater than equal to 30 or 50 percent (%) in the last week from baseline were considered as responders. Participants were asked to assess the average pain intensity on an 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale. |
| Secondary | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 8 and Week 12 | The PGIC is a 7-point scale that requires the participants to assess how much their illness has improved or worsened relative to a Baseline state at the beginning of the intervention. The response options are 1 = very much improved, 2 = much improved, 3 = minimally improve, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. |
| Secondary | Number of Participants With Categorical Scores on Physician's Global Assessment Scale | Week 8 and Week 12 | Physician's Global Assessment Scale assesses the therapeutic efficacy (effectiveness) of the study drug for pain control on a 2-point scale of "effective" and "ineffective". |
| Secondary | Change From Baseline in Pain Interference Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale | Baseline and Week 12 | The BPI-sf consists of 15 Items (Item 1:presence of pain; Item 2:pain location; Items 3 to 6:pain severity; Item 7:status of pain treatment; Item 8:efficacy of pain treatment; and Items 9a to 9g: interference of pain with daily life). Pain interference sub-scale score ranges from 0 (do not interfere) to 10 (completely interferes). Higher scores indicates worsening. Total score is defined as the mean scores from Items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Lower score indicates an improvement in pain. |
| Secondary | Change From Baseline in Pain Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale | Baseline and Week 12 | The BPI-sf consists of 15 Items (Item 1:presence of pain; Item 2:pain location; Items 3 to 6:pain severity; Item 7:status of pain treatment; Item 8:efficacy of pain treatment; and Items 9a to 9g: interference of pain with daily life). Pain Sub-scale score ranges from 0 (absent \[no pain\]) to 10 (extreme \[pain as bad as you can image\]). Higher scores indicates worsening. Total score is defined as the mean scores from Items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Lower score indicates an improvement in pain. |
| Secondary | Change From Baseline in Brief Pain Inventory (Short Form) (BPI-sf) Total Score at Week 12 | Baseline and Week 12 | The BPI-sf consists of 15 Items (Item 1:presence of pain; Item 2:pain location; Items 3 to 6:pain severity; Item 7:status of pain treatment; Item 8:efficacy of pain treatment; and Items 9a to 9g: interference of pain with daily life). Total score is defined as the mean scores from Items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Lower score indicates an improvement in pain. |
| Secondary | Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12 | Baseline and Week 12 | Sleep Latency was related to "How long after bedtime or lights out did the participant fall asleep last night ". Decrease in time indicates an improvement. |
| Secondary | Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12 | Baseline and Week 12 | Time slept was related to "How long did the participant sleep last night". The mean change for the time in hours slept during the last night was reported. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 12 | Baseline and Week 12 | Full Analysis Set (FAS) included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. Last observation carried forward (LOCF) method was used to impute missing values. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11 | FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. | Units on a scale | MEAN |
| SECONDARY | Percentage of Participants With Treatment Response Based on Numerical Rating Scale (NRS) | Week 12 | FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 8 and Week 12 | FAS included all participants who received study drug \& had at least 1 post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure \& 'n' signifies those participants who were evaluable for this measure at given time points. | Participants | NUMBER |
| SECONDARY | Number of Participants With Categorical Scores on Physician's Global Assessment Scale | Week 8 and Week 12 | FAS included all participants who received study drug \& had at least 1 post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure \& 'n' signifies those participants who were evaluable for this measure at given time points. | Participants | NUMBER |
| SECONDARY | Change From Baseline in Pain Interference Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale | Baseline and Week 12 | FAS included all participants who received study drug \& had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Pain Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale | Baseline and Week 12 | FAS included all participants who received study drug \& had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Brief Pain Inventory (Short Form) (BPI-sf) Total Score at Week 12 | Baseline and Week 12 | FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12 | Baseline and Week 12 | FAS included all participants who received study drug \& had at least 1 post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure \& 'n' signifies those participants who were evaluable for this measure at given time points. | Minutes | MEAN |
| SECONDARY | Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12 | Baseline and Week 12 | FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points. | Hours | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group166
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 12 | Tapentadol | Baseline | 6.7 | Standard Deviation 1.15 | Units on a scale |
| Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 12 | Placebo | Baseline | 6.9 | Standard Deviation 1.35 | Units on a scale |
| Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 12 | Tapentadol | Change at Week 12 | -2.6 | Standard Deviation 2.23 | Units on a scale |
| Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 12 | Placebo | Change at Week 12 | -2.6 | Standard Deviation 2.65 | Units on a scale |
| Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 | Tapentadol | Change at Week 1 | -0.7 | Standard Deviation 1.15 | Units on a scale |
| Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 | Placebo | Change at Week 1 | -0.2 | Standard Deviation 0.52 | Units on a scale |
| Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 | Tapentadol | Change at Week 2 | -1.1 | Standard Deviation 1.47 | Units on a scale |
| Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 | Placebo | Change at Week 2 | -0.9 | Standard Deviation 1.47 | Units on a scale |
| Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 | Tapentadol | Change at Week 3 | -1.5 | Standard Deviation 1.75 | Units on a scale |
| Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 | Placebo | Change at Week 3 | -1.1 | Standard Deviation 1.59 | Units on a scale |
1 to 10 of 166Source ClinicalTrials.gov
See all 166 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 | 60 | |
| Overall Study | STARTED | Placebo | 31 | |
| Overall Study | COMPLETED | Tapentadol | 41 | |
| Overall Study | COMPLETED | Placebo | 25 | |
| Overall Study | NOT COMPLETED | Tapentadol | 19 | |
| Overall Study | NOT COMPLETED | Placebo | 6 |
Source ClinicalTrials.gov
Adverse events208
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 | 7 | 60 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 4 | 31 | |
| other | Gastroenteritis | Infections and infestations | Tapentadol | 3 | 60 | |
| other | Gastroenteritis | Infections and infestations | Placebo | 1 | 31 | |
| other | Cystitis | Infections and infestations | Tapentadol | 0 | 60 | |
| other | Cystitis | Infections and infestations | Placebo | 1 | 31 | |
| other | Herpes simplex | Infections and infestations | Tapentadol | 1 | 60 | |
| other | Herpes simplex | Infections and infestations | Placebo | 0 | 31 | |
| other | Otitis media | Infections and infestations | Tapentadol | 1 | 60 | |
| other | Otitis media | Infections and infestations | Placebo | 0 | 31 |
1 to 10 of 208Source ClinicalTrials.gov
See all 208 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tapentadol | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Tapentadol | 52 | 60 |
| Total, other adverse events | Placebo | 26 | 31 |
| Total, serious adverse events | Tapentadol | 4 | 60 |
| Total, serious adverse events | Placebo | 3 | 31 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 vs Placebo: 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/NCT01124617
GET https://conductscience.org/api/trials/v1/NCT01124617/results?page=2