Trial · NCT01809106
RCT Comparing the Analgesic Efficacy of 4 Therapeutic Strategies Based on 4 Different Major Opioids (Fentanyl, Oxycodone, Buprenorphine vs Morphine) in Cancer Patients With Moderate/Severe Pain, at the Moment of Starting 3rd Step of WHO Analgesic Ladder.
NCT01809106, Phase 4, Completed, Mario Negri Institute for Pharmacological Research; results first posted 2015-11-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. RCT Comparing the Analgesic Efficacy of 4 Therapeutic Strategies Based on 4 Different Major Opioids (Fentanyl, Oxycodone, Buprenorphine vs Morphine) in Cancer Patients With Moderate/Severe Pain, at the Moment of Starting 3rd Step of WHO Analgesic Ladder. Trials, record NCT01809106. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01809106
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
RCT Comparing the Analgesic Efficacy of 4 Therapeutic Strategies Based on 4 Different Major Opioids (Fentanyl, Oxycodone, Buprenorphine vs Morphine) in Cancer Patients With Moderate/Severe Pain, at the Moment of Starting 3rd Step of WHO Analgesic Ladder.
- NCT number
- NCT01809106
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 518 participants, actual
- Lead sponsor
- Mario Negri Institute for Pharmacological Research
- Conditions
- Cancer, Cancer Pain
- Interventions
- Morphine, Fentanyl, Buprenorphine, Oxycodone
- First posted
- 2013-03-12
- Last updated
- 2015-12-24
- Results first posted
- 2015-11-20
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Non-Responder (NR) Participants | 28 days | Evaluation of the proportion of Non-Responder (NR) participants. NR correspond to the subjects who do not report any analgesic effects, with a P.I.D. (pain intensity difference) from visit 6 and visit 1 =/\< 0%, (using a 0-10 NRS ). It includes the situations of average pain intensity "stable" or "worsened" at day 28 compared with baseline values. |
| Secondary | Proportion of Full-responder | 28 days | Evaluation of the proportion of subjects who report full analgesia (full responders: FR). FR is operationally defined as a patient with a P.I.D. =/\> 30% from visit 6 and visit 1 (NRS 0 to 10). |
| Other | The Opioid Escalation Index | 28 days | The proportion of subjects with an increase of opioid daily dose \> 5% compared with the basal dosage (OEI%). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Non-Responder (NR) Participants | 28 days | Intention-to-treat | participants | NUMBER |
| SECONDARY | Proportion of Full-responder | 28 days | participants | NUMBER | |
| OTHER_PRE_SPECIFIED | The Opioid Escalation Index | 28 days | participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Non-Responder (NR) Participants | Morphine | 14 | participants | ||
| Proportion of Non-Responder (NR) Participants | Oxycodone | 18 | participants | ||
| Proportion of Non-Responder (NR) Participants | Buprenorphine | 14 | participants | ||
| Proportion of Non-Responder (NR) Participants | Fentanyl | 11 | participants | ||
| Proportion of Full-responder | Morphine | 89 | participants | ||
| Proportion of Full-responder | Oxycodone | 90 | participants | ||
| Proportion of Full-responder | Buprenorphine | 95 | participants | ||
| Proportion of Full-responder | Fentanyl | 88 | participants | ||
| The Opioid Escalation Index | Morphine | 13 | participants | ||
| The Opioid Escalation Index | Oxycodone | 24 | participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Morphine | 130 | |
| Overall Study | STARTED | Oxycodone | 130 | |
| Overall Study | STARTED | Buprenorphine | 130 | |
| Overall Study | STARTED | Fentanyl | 128 | |
| Overall Study | COMPLETED | Morphine | 122 | |
| Overall Study | COMPLETED | Oxycodone | 125 | |
| Overall Study | COMPLETED | Buprenorphine | 127 | |
| Overall Study | COMPLETED | Fentanyl | 124 | |
| Overall Study | NOT COMPLETED | Morphine | 8 | |
| Overall Study | NOT COMPLETED | Oxycodone | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events48
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 | drowsiness | General disorders | Morphine | 79 | 122 | 79 |
| other | drowsiness | General disorders | Oxycodone | 74 | 125 | 74 |
| other | drowsiness | General disorders | Buprenorphine | 81 | 127 | 81 |
| other | drowsiness | General disorders | Fentanyl | 70 | 124 | 70 |
| other | Confusion | General disorders | Morphine | 59 | 122 | 59 |
| other | Confusion | General disorders | Oxycodone | 55 | 125 | 55 |
| other | Confusion | General disorders | Buprenorphine | 61 | 127 | 61 |
| other | Confusion | General disorders | Fentanyl | 46 | 124 | 46 |
| serious | bowel occlusion | Gastrointestinal disorders | Morphine | 1 | 122 | 1 |
| serious | bowel occlusion | Gastrointestinal disorders | Oxycodone | 0 | 125 | 0 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Morphine | ||
| Total, all-cause mortality | Oxycodone | ||
| Total, all-cause mortality | Buprenorphine | ||
| Total, all-cause mortality | Fentanyl | ||
| Total, other adverse events | Morphine | 103 | 122 |
| Total, other adverse events | Oxycodone | 98 | 125 |
| Total, other adverse events | Buprenorphine | 108 | 127 |
| Total, other adverse events | Fentanyl | 95 | 124 |
| Total, serious adverse events | Morphine | 5 | 122 |
| Total, serious adverse events | Oxycodone | 1 | 125 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers8
The papers the trial lists on ClinicalTrials.gov.
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/NCT01809106
GET https://conductscience.org/api/trials/v1/NCT01809106/events?page=2