Trial · NCT01041859
A Study to Evaluate the Efficacy, Safety, and Tolerability of Tapentadol ER Compared With Placebo in Patients With Chronic, Painful Diabetic Peripheral Neuropathy
NCT01041859, Phase 3, Completed, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; results first posted 2012-05-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Efficacy, Safety, and Tolerability of Tapentadol ER Compared With Placebo in Patients With Chronic, Painful Diabetic Peripheral Neuropathy. Trials, record NCT01041859. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01041859
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy, Safety, and Tolerability of Tapentadol ER Compared With Placebo in Patients With Chronic, Painful Diabetic Peripheral Neuropathy
- NCT number
- NCT01041859
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 460 participants, actual
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Conditions
- Diabetic Peripheral Neuropathy
- Interventions
- Tapentadol extended release (ER), Placebo
- First posted
- 2010-01-01
- Last updated
- 2013-09-11
- Results first posted
- 2012-05-14
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Double-Blind Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale(NRS) Over the Last Week of the Maintenance Period at Week 12 | Double-Blind Baseline and 12 weeks (Primary endpoint is the average pain intensity score during the last week of the maintenance period) | For this twice daily pain assessment, the patients were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". |
| Secondary | Responder Analysis: Proportion of Patients With At Least 50% Improvement From Baseline of Open-Label on the Numerical Rating Scale (NRS) at the Week 12 Endpoint | Open-label Baseline and End of Double-Blind Treatment at 15 Weeks (3 weeks open-label plus 12 weeks double-blind) | The NRS was a twice-daily pain assessment in which patients were to indicate the level of pain experienced over the previous 12 hours on an 11-point scale with a score of 0 indicating "no pain" and a score of 10 indicating "pain as bad as you can imagine". |
| Secondary | Distribution of Patient Global Impression of Change at Week 12 Endpoint | End of Double-Blind Treatment at 12 Weeks | Patient Global Impression of Change (PGIC) is a patient-rated assessment of overall neuropathic pain since the start of treatment using a categorical scale 1-7, where 1 is 'very much improved' and 7 is 'very much worse' |
| Secondary | Change From Baseline of Open-Label in the Pain Intensity Subscale of the Brief Pain Inventory (BPI) at the Week 12 Double-Blind Endpoint | Open-label Baseline and End of Double-Blind Treatment at 15 Weeks (3 weeks open-label plus 12 weeks double-blind) | The BPI is a 12-item questionnaire to evaluate the intensity of pain and the degree to which pain interferes with function. It includes 4 items assessing current pain intensity and pain at its worst, least, and on average over the past day using an 11-point scale from 0 = no pain to 10 = pain as bad as you can imagine. The pain intensity subscale score is defined as the mean of the scores from these 4 items. |
| Secondary | Change From Baseline in the EuroQoL-5 Dimension (EQ-5D) Health Status Index at the Week 12 Endpoint | Double-blind Baseline and End of Double-Blind Treatment at 12 Weeks | EQ-5D has 5 items (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) rated on a categorical scale of 1-3 with 1=no problems, 2=some problems, 3=extreme problems. The health state index is a weighted combination of the 5 items. It has a range of 0 to 1, with 0=deceased and 1=full health. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Double-Blind Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale(NRS) Over the Last Week of the Maintenance Period at Week 12 | Double-Blind Baseline and 12 weeks (Primary endpoint is the average pain intensity score during the last week of the maintenance period) | Intent-to-treat (ITT) population. Last observation carried forward (LOCF) was used to impute pain score after discontinuation | units on a scale | MEAN |
| SECONDARY | Responder Analysis: Proportion of Patients With At Least 50% Improvement From Baseline of Open-Label on the Numerical Rating Scale (NRS) at the Week 12 Endpoint | Open-label Baseline and End of Double-Blind Treatment at 15 Weeks (3 weeks open-label plus 12 weeks double-blind) | Intent-to-treat (ITT) population. Last observation carried forward (LOCF) was used to impute pain score after discontinuation. | percentage of participants | NUMBER |
| SECONDARY | Distribution of Patient Global Impression of Change at Week 12 Endpoint | End of Double-Blind Treatment at 12 Weeks | Intent-to-treat (ITT) population. Last observation carried forward (LOCF) end point | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline of Open-Label in the Pain Intensity Subscale of the Brief Pain Inventory (BPI) at the Week 12 Double-Blind Endpoint | Open-label Baseline and End of Double-Blind Treatment at 15 Weeks (3 weeks open-label plus 12 weeks double-blind) | Intent-to-treat (ITT) population. Last observation carried forward (LOCF) endpoint. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in the EuroQoL-5 Dimension (EQ-5D) Health Status Index at the Week 12 Endpoint | Double-blind Baseline and End of Double-Blind Treatment at 12 Weeks | Intent-to-treat (ITT) population. Last observation carried forward (LOCF) endpoint. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Double-Blind Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale(NRS) Over the Last Week of the Maintenance Period at Week 12 | DB Tapentadol ER | 0.28 | Standard Deviation 2.04 | units on a scale | |
| Change From Double-Blind Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale(NRS) Over the Last Week of the Maintenance Period at Week 12 | DB Placebo | 1.3 | Standard Deviation 2.43 | units on a scale | |
| Responder Analysis: Proportion of Patients With At Least 50% Improvement From Baseline of Open-Label on the Numerical Rating Scale (NRS) at the Week 12 Endpoint | DB Tapentadol ER | 40.4 | 2.04 | percentage of participants | |
| Responder Analysis: Proportion of Patients With At Least 50% Improvement From Baseline of Open-Label on the Numerical Rating Scale (NRS) at the Week 12 Endpoint | DB Placebo | 28.9 | 2.43 | percentage of participants | |
| Distribution of Patient Global Impression of Change at Week 12 Endpoint | DB Tapentadol ER | Very much improved | 28.7 | 2.04 | percentage of participants |
| Distribution of Patient Global Impression of Change at Week 12 Endpoint | DB Placebo | Very much improved | 14.4 | 2.43 | percentage of participants |
| Distribution of Patient Global Impression of Change at Week 12 Endpoint | DB Tapentadol ER | Much improved | 37.3 | percentage of participants | |
| Distribution of Patient Global Impression of Change at Week 12 Endpoint | DB Placebo | Much improved | 30.9 | percentage of participants | |
| Distribution of Patient Global Impression of Change at Week 12 Endpoint | DB Tapentadol ER | Minimally improved | 21.3 | percentage of participants | |
| Distribution of Patient Global Impression of Change at Week 12 Endpoint | DB Placebo | Minimally improved | 20.9 | percentage of participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Open-Label Titration | STARTED | OL Tapentadol | 459 | |
| Open-Label Titration | STARTED | DB Tapentadol ER | 0 | |
| Open-Label Titration | STARTED | DB Placebo | 0 | |
| Open-Label Titration | COMPLETED | OL Tapentadol | 358 | |
| Open-Label Titration | COMPLETED | DB Tapentadol ER | 0 | |
| Open-Label Titration | COMPLETED | DB Placebo | 0 | |
| Open-Label Titration | NOT COMPLETED | OL Tapentadol | 101 | |
| Open-Label Titration | NOT COMPLETED | DB Tapentadol ER | 0 | |
| Open-Label Titration | NOT COMPLETED | DB Placebo | 0 | |
| Double-Blind Maintenance | STARTED | OL Tapentadol | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events186
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 | Nausea | Gastrointestinal disorders | OL Tapentadol | 112 | 459 | |
| other | Nausea | Gastrointestinal disorders | DB Tapentadol ER | 34 | 166 | |
| other | Nausea | Gastrointestinal disorders | DB Placebo | 14 | 152 | |
| other | Vomiting | Gastrointestinal disorders | OL Tapentadol | 46 | 459 | |
| other | Vomiting | Gastrointestinal disorders | DB Tapentadol ER | 20 | 166 | |
| other | Vomiting | Gastrointestinal disorders | DB Placebo | 6 | 152 | |
| other | Diarrhoea | Gastrointestinal disorders | OL Tapentadol | 24 | 459 | |
| other | Diarrhoea | Gastrointestinal disorders | DB Tapentadol ER | 11 | 166 | |
| other | Diarrhoea | Gastrointestinal disorders | DB Placebo | 10 | 152 | |
| other | Constipation | Gastrointestinal disorders | OL Tapentadol | 54 | 459 |
1 to 10 of 186Source ClinicalTrials.gov
See all 186 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | OL Tapentadol | ||
| Total, all-cause mortality | DB Tapentadol ER | ||
| Total, all-cause mortality | DB Placebo | ||
| Total, other adverse events | OL Tapentadol | 296 | 459 |
| Total, other adverse events | DB Tapentadol ER | 86 | 166 |
| Total, other adverse events | DB Placebo | 37 | 152 |
| Total, serious adverse events | OL Tapentadol | 11 | 459 |
| Total, serious adverse events | DB Tapentadol ER | 8 | 166 |
| Total, serious adverse events | DB Placebo | 9 | 152 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01041859
GET https://conductscience.org/api/trials/v1/NCT01041859/results?page=2