Trial · NCT00644787
A Dose-Finding Study of Fentanyl (JNS020 QD) 1-Day Transdermal Patch in Participants With Cancer Pain
NCT00644787, Phase 2, Phase 3, Completed, Janssen Pharmaceutical K.K.; results first posted 2013-05-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Dose-Finding Study of Fentanyl (JNS020 QD) 1-Day Transdermal Patch in Participants With Cancer Pain. Trials, record NCT00644787. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00644787
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Dose-Finding Study of Fentanyl (JNS020 QD) 1-Day Transdermal Patch in Participants With Cancer Pain
- NCT number
- NCT00644787
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 156 participants, actual
- Lead sponsor
- Janssen Pharmaceutical K.K.
- Conditions
- Pain, Cancer
- Interventions
- Fentanyl 1-day transdermal patch (Titration Phase), Fentanyl 1-day transdermal patch (Double Blind Phase), Fentanyl 3-day transdermal patch (Double Blind Phase), Placebo, Placebo
- First posted
- 2008-03-27
- Last updated
- 2013-06-13
- Results first posted
- 2013-05-21
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving Dose Titration Success | Day 14 or early discontinuation (ED) | Participants achieving dose titration success included all participants who had a mean Visual Analog Scale (VAS) score of less than or equal to 34 millimeter (mm) and received not more than 2 rescue doses during the last 3 days before the completion or discontinuation of dose titration phase. Pain Intensity VAS measured severity of pain on a 100 mm scale ranging from 0 mm (no pain) to 100 mm (severest pain conceivable) and rescue dose was defined as dose of a fast-acting oral morphine hydrochloride solution or morphine in water solution used in the case of breakthrough pain. |
| Primary | Change From Dose Titration Phase in the Mean Visual Analog Scale (VAS) Score at Double Blind Phase | Dose Titration Phase (Day 12 to Day 14) and Double Blind Phase (Day 8 to Day 10) | The mean VAS score for the last 3 days before the completion or discontinuation of Double Blind Phase was compared with that for the last 3 days before the completion or discontinuation of Dose Titration Phase and the change from Dose Titration Phase in the mean VAS Score at Double Blind Phase was reported. Pain Intensity VAS measured severity of pain on a 100 mm scale ranging from 0 mm (no pain) to 100 mm (severest pain conceivable). |
| Secondary | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 1 pre-application (PA), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED | Participants were asked to assess their satisfaction with respect to the therapeutic efficacy (effectiveness) of the study drug to control pain on a 5-point scale ranging from 1 to 5, where 1 = extremely satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied and 5 = extremely dissatisfied. |
| Secondary | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED | Participants were asked to assess their satisfaction with respect to the therapeutic efficacy of the study drug to control pain on a 5-point scale ranging from 1 to 5, where 1 = extremely satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied and 5 = extremely dissatisfied. |
| Secondary | Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase | Day 1 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED | Participants were asked to assess their resting pain intensity (severity of pain) on a 100-mm VAS with the left edge (0 mm) defined as "no pain" and the right edge (100 mm) defined as "severest pain conceivable". |
| Secondary | Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase | Day 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED | Participants were asked to assess their resting pain intensity (severity of pain) on a 100-mm VAS with the left edge (0 mm) defined as "no pain" and the right edge (100 mm) defined as "severest pain conceivable". |
| Secondary | Percentage of Participants Achieving Pain Control in Double Blind Phase | Day 10 or ED | Pain control was assessed based on change in VAS and number of daily rescue doses during 3 days before completion of Double Blind Phase from 3 days before start of Double Blind Phase. For VAS score, difference of less than or equal to +15 mm and for rescue doses, difference of less than or equal to 1 was considered significant to achieve pain control. Pain Intensity VAS measured pain severity on a scale ranging from 0 mm (no pain) to 100 mm (severest pain conceivable) and rescue dose was defined as dose of fast-acting oral morphine formulation used in case of breakthrough pain. |
| Secondary | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 1 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED | Participants were asked to assess their resting pain intensity (severity of pain) on a 4-point categorical scale ranging from 0 to 3 where 0 = no pain, 1 = mild pain, 2 = moderate pain and 3 = severe pain. |
| Secondary | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED | Participants were asked to assess their resting pain intensity (severity of pain) on a 4-point categorical scale ranging from 0 to 3 where 0 = no pain, 1 = mild pain, 2 = moderate pain and 3 = severe pain. |
| Secondary | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 1 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED | The participants assessed total painful time in 1 day on a 5-point scale ranging from 0 to 4 where 0 = less than (\<) 4 hours, 1 = greater than or equal to (\>=) 4 hours to less than 8 hours, 2 = greater than or equal to 8 hours to less than 12 hours, 3 = greater than or equal to 12 hours and 4 = 24 hours (all day). |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving Dose Titration Success | Day 14 or early discontinuation (ED) | Full Analysis Set (FAS) population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. | Percentage of participants | NUMBER |
| PRIMARY | Change From Dose Titration Phase in the Mean Visual Analog Scale (VAS) Score at Double Blind Phase | Dose Titration Phase (Day 12 to Day 14) and Double Blind Phase (Day 8 to Day 10) | Per Protocol Set (PPS) population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations. | mm | MEAN |
| SECONDARY | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 1 pre-application (PA), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED | The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points. | Participants | NUMBER |
| SECONDARY | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED | The PPS population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations. 'n' signifies those participants who were evaluable for this measure at given time points. | Participants | NUMBER |
| SECONDARY | Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase | Day 1 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED | The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points. | mm | MEAN |
| SECONDARY | Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase | Day 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED | The PPS population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations. 'n' signifies those participants who were evaluable for this measure at given time points. | mm | MEAN |
| SECONDARY | Percentage of Participants Achieving Pain Control in Double Blind Phase | Day 10 or ED | The PPS population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 1 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED | The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points. | Participants | NUMBER |
| SECONDARY | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED | The PPS population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations. 'n' signifies those participants who were evaluable for this measure at given time points. | Participants | NUMBER |
| SECONDARY | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 1 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED | The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points. | Participants | NUMBER |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group537
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving Dose Titration Success | Fentanyl 1-day Transdermal Patch (Titration Phase) | 80.60 | 95% Confidence Interval 73.50 to 86.50 | Percentage of participants | |
| Change From Dose Titration Phase in the Mean Visual Analog Scale (VAS) Score at Double Blind Phase | Fentanyl 1-day Transdermal Patch (Double Blind Phase) | Dose Titration Phase (Day 12 to Day 14) | 18.4 | Standard Deviation 9.05 | mm |
| Change From Dose Titration Phase in the Mean Visual Analog Scale (VAS) Score at Double Blind Phase | Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Dose Titration Phase (Day 12 to Day 14) | 20.6 | Standard Deviation 8.58 | mm |
| Change From Dose Titration Phase in the Mean Visual Analog Scale (VAS) Score at Double Blind Phase | Fentanyl 1-day Transdermal Patch (Double Blind Phase) | Change at Double Blind Phase (Day 8 to Day 10) | -1.1 | Standard Deviation 14.82 | mm |
| Change From Dose Titration Phase in the Mean Visual Analog Scale (VAS) Score at Double Blind Phase | Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Change at Double Blind Phase (Day 8 to Day 10) | -2.5 | Standard Deviation 11.32 | mm |
| Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Fentanyl 1-day Transdermal Patch (Titration Phase) | Day 1 PA; Extremely satisfied (n=155) | 1 | 3.10 to 11.50 | Participants |
| Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Fentanyl 1-day Transdermal Patch (Titration Phase) | Day 1 PA; Satisfied (n=155) | 9 | 50.50 to 66.50 | Participants |
| Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Fentanyl 1-day Transdermal Patch (Titration Phase) | Day1 PA;Neither satisfied nor dissatisfied(n=155) | 54 | Participants | |
| Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Fentanyl 1-day Transdermal Patch (Titration Phase) | Day 1 PA; Dissatisfied (n=155) | 83 | Participants | |
| Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Fentanyl 1-day Transdermal Patch (Titration Phase) | Day 1 PA; Extremely dissatisfied (n=155) | 8 | Participants |
1 to 10 of 537Source ClinicalTrials.gov
See all 537 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1: Titration Phase | STARTED | Fentanyl 1-day Transdermal Patch (Titration Phase) | 156 | |
| Period 1: Titration Phase | STARTED | Fentanyl 1-day Transdermal Patch (Double Blind Phase) | 0 | |
| Period 1: Titration Phase | STARTED | Fentanyl 3-day Transdermal Patch (Double Blind Phase) | 0 | |
| Period 1: Titration Phase | COMPLETED | Fentanyl 1-day Transdermal Patch (Titration Phase) | 129 | |
| Period 1: Titration Phase | COMPLETED | Fentanyl 1-day Transdermal Patch (Double Blind Phase) | 0 | |
| Period 1: Titration Phase | COMPLETED | Fentanyl 3-day Transdermal Patch (Double Blind Phase) | 0 | |
| Period 1: Titration Phase | NOT COMPLETED | Fentanyl 1-day Transdermal Patch (Titration Phase) | 27 | |
| Period 1: Titration Phase | NOT COMPLETED | Fentanyl 1-day Transdermal Patch (Double Blind Phase) | 0 | |
| Period 1: Titration Phase | NOT COMPLETED | Fentanyl 3-day Transdermal Patch (Double Blind Phase) | 0 | |
| Period 2: Double Blind Phase | STARTED | Fentanyl 1-day Transdermal Patch (Titration Phase) | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events150
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 | Somnolence | Nervous system disorders | Fentanyl 1-day Transdermal Patch (Titration Phase) | 93 | 155 | |
| other | Somnolence | Nervous system disorders | Fentanyl 1-day Transdermal Patch (Double Blind Phase) | 34 | 57 | |
| other | Somnolence | Nervous system disorders | Fentanyl 3-day Transdermal Patch (Double Blind Phase) | 36 | 62 | |
| other | Constipation | Gastrointestinal disorders | Fentanyl 1-day Transdermal Patch (Titration Phase) | 78 | 155 | |
| other | Constipation | Gastrointestinal disorders | Fentanyl 1-day Transdermal Patch (Double Blind Phase) | 31 | 57 | |
| other | Constipation | Gastrointestinal disorders | Fentanyl 3-day Transdermal Patch (Double Blind Phase) | 36 | 62 | |
| other | Diarrhoea | Gastrointestinal disorders | Fentanyl 1-day Transdermal Patch (Titration Phase) | 11 | 155 | |
| other | Diarrhoea | Gastrointestinal disorders | Fentanyl 1-day Transdermal Patch (Double Blind Phase) | 8 | 57 | |
| other | Diarrhoea | Gastrointestinal disorders | Fentanyl 3-day Transdermal Patch (Double Blind Phase) | 13 | 62 | |
| other | Nausea | Gastrointestinal disorders | Fentanyl 1-day Transdermal Patch (Titration Phase) | 74 | 155 |
1 to 10 of 150Source ClinicalTrials.gov
See all 150 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fentanyl 1-day Transdermal Patch (Titration Phase) | ||
| Total, all-cause mortality | Fentanyl 1-day Transdermal Patch (Double Blind Phase) | ||
| Total, all-cause mortality | Fentanyl 3-day Transdermal Patch (Double Blind Phase) | ||
| Total, other adverse events | Fentanyl 1-day Transdermal Patch (Titration Phase) | 128 | 155 |
| Total, other adverse events | Fentanyl 1-day Transdermal Patch (Double Blind Phase) | 47 | 57 |
| Total, other adverse events | Fentanyl 3-day Transdermal Patch (Double Blind Phase) | 48 | 62 |
| Total, serious adverse events | Fentanyl 1-day Transdermal Patch (Titration Phase) | 14 | 155 |
| Total, serious adverse events | Fentanyl 1-day Transdermal Patch (Double Blind Phase) | 9 | 57 |
| Total, serious adverse events | Fentanyl 3-day Transdermal Patch (Double Blind Phase) | 11 | 62 |
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.
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