Trial · NCT01008553
A Confirmatory Study of Fentanyl in Participants With Post-herpetic Neuralgia, Complex Regional Pain Syndrome or Postoperative Pain Syndrome
NCT01008553, Phase 3, Completed, Janssen Pharmaceutical K.K.; results first posted 2013-07-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Confirmatory Study of Fentanyl in Participants With Post-herpetic Neuralgia, Complex Regional Pain Syndrome or Postoperative Pain Syndrome. Trials, record NCT01008553. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01008553
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Confirmatory Study of Fentanyl in Participants With Post-herpetic Neuralgia, Complex Regional Pain Syndrome or Postoperative Pain Syndrome
- NCT number
- NCT01008553
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 258 participants, actual
- Lead sponsor
- Janssen Pharmaceutical K.K.
- Conditions
- Postherpetic Neuralgia, Complex Regional Pain Syndromes (CRPS), Postoperative Pain
- Interventions
- Fentanyl, Placebo
- First posted
- 2009-11-06
- Last updated
- 2013-07-25
- Results first posted
- 2013-07-25
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time From the Initial Day of Application in Double-Blind Period to Withdrawal Because of Insufficient Analgesic Efficacy | Day 1 up to Day 85 (double-blind period) and Day 92 (discontinuation of the study) | Time from start of double-blind (researchers and participants were unaware of the treatment) period to withdrawal because of insufficient analgesic efficacy based on any of the pre-defined discontinuation criteria was noted. |
| Secondary | Pain Visual Analog Scale (VAS) Score - Titration Period | Day 12-14 (Screening period) and Day 27-29 (Titration period) | The intensity of average pain (degree of pain) felt by the participants in daily living throughout the day on a "100-millimeter (mm) VAS scale" by drawing a slash. The left margin (0 mm) was considered "No pain at all", and the right margin (100 mm) was considered "Severer pain than this is inconceivable". The length (mm) from the left margin to the slash is measured. Mean VAS score during 3 days before the end of Screening period and during 3 days before the end of titration period was reported. |
| Secondary | Pain Visual Analog Scale (VAS) Score - Double-Blind Period | Day 27-29 (Titration period) and Day 83-85 (double-blind period) | The intensity of average pain (degree of pain) felt by the participants in daily living throughout the day on a "100-millimeter (mm) VAS scale" by drawing a slash. The left margin (0 mm) was considered "No pain at all", and the right margin (100 mm) was considered "Severer pain than this is inconceivable". The length (mm) from the left margin to the slash is measured. Mean VAS score during 3 days before the end of titration period and during 3 days before the end of double-blind period was reported. |
| Secondary | Number of Participants Evaluated as Per Participant's Overall Assessment - Titration Period | Day 1 and 29 or final evaluation (Titration period) | The participant assessed his/her satisfaction with the therapeutic efficacy by the following 5 grades: "Extremely satisfied", "Satisfied", "Neither satisfied nor dissatisfied", "Dissatisfied" and "Dissatisfied very much". The results were reported as Category 1 = At least "Neither satisfied nor dissatisfied", which included participants with general evaluation of "Extremely satisfied" to "Neither satisfied nor dissatisfied", and Category 2 = At least "Satisfied", which included participants with general evaluation of "Extremely satisfied" to "Satisfied". |
| Secondary | Number of Participants Evaluated as Per Participant's Overall Assessment - Double-Blind Period | Day 1 and 85 or final evaluation (double-blind period) | The participant assessed his/her satisfaction with the therapeutic efficacy by the following 5 grades: "Extremely satisfied", "Satisfied", "Neither satisfied nor dissatisfied", "Dissatisfied" and "Dissatisfied very much". The results were reported as Category 1 = At least "Neither satisfied nor dissatisfied", which included participants with general evaluation of "Extremely satisfied" to "Neither satisfied nor dissatisfied", and Category 2 = At least "Satisfied", which included participants with general evaluation of "Extremely satisfied" to "Satisfied". |
| Secondary | Number of Doses of Rescue Treatment Per Day - Titration Period | Day 1 and 29 or final evaluation (Titration period) | If a breakthrough pain occurred or the analgesic efficacy became insufficient, a fast-acting oral morphine was administered. At such instances, one-time dose of the rescue treatment was administered as per the pre-defined criteria. During hospitalization, Investigator, Sub-investigator or Study Collaborator recorded in the medical record and during the out-patient period, the participants were instructed to describe the name of rescue treatment, date and time of treatment, and one-time dose in the participant's diary. |
| Secondary | Number of Doses of Rescue Treatment Per Day - Double-Blind Period | Day 1 and 85 or final evaluation (double-blind period) | If a breakthrough pain occurred or the analgesic efficacy became insufficient, a fast-acting oral morphine was administered. At such instances, one-time dose of the rescue treatment was administered as per the pre-defined criteria. During hospitalization, Investigator, Sub-investigator or Study Collaborator recorded in the medical record and during the out-patient period, the participants were instructed to describe the name of rescue treatment, date and time of treatment, and one-time dose in the participant's diary. |
| Secondary | Brief Pain Inventory Short Form (BPI-sf) Score - Titration Period | Day 1 and 29 or final evaluation (Titration period) | The BPI-sf total score is an average of the pain interference score (mean value for the nine BPI-sf questions \[questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)\]) and pain subscale score (mean value for the scores for BPI-sf questions 3, 4, 5 and 6 \[questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)\]). Total score ranges from 0 to 10 with higher values indicating more pain. |
| Secondary | Brief Pain Inventory Short Form (BPI-sf) Score - Double-Blind Period | Day 1 and 85 or final evaluation (double-blind period) | The BPI-sf total score is an average of the pain interference score (mean value for the nine BPI-sf questions \[questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)\]) and pain subscale score (mean value for the scores for BPI-sf questions 3, 4, 5 and 6 \[questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)\]). Total score ranges from 0 to 10 with higher values indicating more pain. |
| Secondary | Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) Score - Titration Period | Day 1 and 29 or final evaluation (Titration period) | The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state. |
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 | Time From the Initial Day of Application in Double-Blind Period to Withdrawal Because of Insufficient Analgesic Efficacy | Day 1 up to Day 85 (double-blind period) and Day 92 (discontinuation of the study) | Full analysis set (FAS) population included all the randomly assigned participants with the exception of participants with pre-defined criteria. | Days | MEDIAN |
| SECONDARY | Pain Visual Analog Scale (VAS) Score - Titration Period | Day 12-14 (Screening period) and Day 27-29 (Titration period) | Full analysis set in Period 1 (FAS1) population included all the randomly assigned participants with the exception of participants with pre-defined criteria. 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points. | mm | MEAN |
| SECONDARY | Pain Visual Analog Scale (VAS) Score - Double-Blind Period | Day 27-29 (Titration period) and Day 83-85 (double-blind period) | The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points. | mm | MEAN |
| SECONDARY | Number of Participants Evaluated as Per Participant's Overall Assessment - Titration Period | Day 1 and 29 or final evaluation (Titration period) | The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points. | Participants | NUMBER |
| SECONDARY | Number of Participants Evaluated as Per Participant's Overall Assessment - Double-Blind Period | Day 1 and 85 or final evaluation (double-blind period) | The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points. | Participants | NUMBER |
| SECONDARY | Number of Doses of Rescue Treatment Per Day - Titration Period | Day 1 and 29 or final evaluation (Titration period) | The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points. | Treatments per day | MEAN |
| SECONDARY | Number of Doses of Rescue Treatment Per Day - Double-Blind Period | Day 1 and 85 or final evaluation (double-blind period) | The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points. | Treatments per day | MEAN |
| SECONDARY | Brief Pain Inventory Short Form (BPI-sf) Score - Titration Period | Day 1 and 29 or final evaluation (Titration period) | The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points. | Units on a scale | MEAN |
| SECONDARY | Brief Pain Inventory Short Form (BPI-sf) Score - Double-Blind Period | Day 1 and 85 or final evaluation (double-blind period) | The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points. | Units on a scale | MEAN |
| SECONDARY | Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) Score - Titration Period | Day 1 and 29 or final evaluation (Titration period) | The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points. | Units on a scale | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time From the Initial Day of Application in Double-Blind Period to Withdrawal Because of Insufficient Analgesic Efficacy | Fentanyl (Double-blind Period) | NA | 95% Confidence Interval NA to NA | Days | |
| Time From the Initial Day of Application in Double-Blind Period to Withdrawal Because of Insufficient Analgesic Efficacy | Placebo (Double-blind Period) | 45.0 | 95% Confidence Interval 16.0 to NA | Days | |
| Pain Visual Analog Scale (VAS) Score - Titration Period | Fentanyl (Titration Period) | Baseline (n=258) | 73.5 | Standard Deviation 12.81 | mm |
| Pain Visual Analog Scale (VAS) Score - Titration Period | Fentanyl (Titration Period) | Last 3 days in titration period (n=257) | 39.5 | Standard Deviation 20.02 | mm |
| Pain Visual Analog Scale (VAS) Score - Double-Blind Period | Fentanyl (Double-blind Period) | Baseline (n=84, 79) | 30.1 | Standard Deviation 11.50 | mm |
| Pain Visual Analog Scale (VAS) Score - Double-Blind Period | Placebo (Double-blind Period) | Baseline (n=84, 79) | 27.5 | Standard Deviation 11.23 | mm |
| Pain Visual Analog Scale (VAS) Score - Double-Blind Period | Fentanyl (Double-blind Period) | Last 3 days in double-blind period (n=83, 79) | 29.6 | Standard Deviation 21.71 | mm |
| Pain Visual Analog Scale (VAS) Score - Double-Blind Period | Placebo (Double-blind Period) | Last 3 days in double-blind period (n=83, 79) | 37.1 | Standard Deviation 20.19 | mm |
| Number of Participants Evaluated as Per Participant's Overall Assessment - Titration Period | Fentanyl (Titration Period) | Day 1, Category 1 (n=258) | 85 | Participants | |
| Number of Participants Evaluated as Per Participant's Overall Assessment - Titration Period | Fentanyl (Titration Period) | Day 1, Category 2 (n=258) | 15 | Participants |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 (Titration Period) | STARTED | Fentanyl (Titration Period) | 258 | |
| Period 1 (Titration Period) | STARTED | Fentanyl (Double-blind Period) | 0 | |
| Period 1 (Titration Period) | STARTED | Placebo (Double-blind Period) | 0 | |
| Period 1 (Titration Period) | COMPLETED | Fentanyl (Titration Period) | 163 | |
| Period 1 (Titration Period) | COMPLETED | Fentanyl (Double-blind Period) | 0 | |
| Period 1 (Titration Period) | COMPLETED | Placebo (Double-blind Period) | 0 | |
| Period 1 (Titration Period) | NOT COMPLETED | Fentanyl (Titration Period) | 95 | |
| Period 1 (Titration Period) | NOT COMPLETED | Fentanyl (Double-blind Period) | 0 | |
| Period 1 (Titration Period) | NOT COMPLETED | Placebo (Double-blind Period) | 0 | |
| Period 2 (Double-Blind Period) | STARTED | Fentanyl (Titration Period) | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events639
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 | Fentanyl (Titration Period) | 12 | 258 | |
| other | Nasopharyngitis | Infections and infestations | Fentanyl (Double-blind Period) | 5 | 84 | |
| other | Nasopharyngitis | Infections and infestations | Placebo (Double-blind Period) | 6 | 79 | |
| other | Cystitis | Infections and infestations | Fentanyl (Titration Period) | 2 | 258 | |
| other | Cystitis | Infections and infestations | Fentanyl (Double-blind Period) | 1 | 84 | |
| other | Cystitis | Infections and infestations | Placebo (Double-blind Period) | 1 | 79 | |
| other | Gastroenteritis | Infections and infestations | Fentanyl (Titration Period) | 2 | 258 | |
| other | Gastroenteritis | Infections and infestations | Fentanyl (Double-blind Period) | 0 | 84 | |
| other | Gastroenteritis | Infections and infestations | Placebo (Double-blind Period) | 0 | 79 | |
| other | Herpes simplex | Infections and infestations | Fentanyl (Titration Period) | 1 | 258 |
1 to 10 of 639Source ClinicalTrials.gov
See all 639 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fentanyl (Titration Period) | ||
| Total, all-cause mortality | Fentanyl (Double-blind Period) | ||
| Total, all-cause mortality | Placebo (Double-blind Period) | ||
| Total, other adverse events | Fentanyl (Titration Period) | 231 | 258 |
| Total, other adverse events | Fentanyl (Double-blind Period) | 71 | 84 |
| Total, other adverse events | Placebo (Double-blind Period) | 56 | 79 |
| Total, serious adverse events | Fentanyl (Titration Period) | 13 | 258 |
| Total, serious adverse events | Fentanyl (Double-blind Period) | 8 | 84 |
| Total, serious adverse events | Placebo (Double-blind Period) | 4 | 79 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26359327 | 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 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/NCT01008553
GET https://conductscience.org/api/trials/v1/NCT01008553/results?page=2