Trial · NCT01205126
An Efficacy and Safety Study of Oral Osmotic Therapeutic System (OROS) Hydromorphone Hydrochloride (HCl) in Participants With Cancer Related Pain
NCT01205126, Phase 3, Completed, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; results first posted 2013-11-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Efficacy and Safety Study of Oral Osmotic Therapeutic System (OROS) Hydromorphone Hydrochloride (HCl) in Participants With Cancer Related Pain. Trials, record NCT01205126. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01205126
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Efficacy and Safety Study of Oral Osmotic Therapeutic System (OROS) Hydromorphone Hydrochloride (HCl) in Participants With Cancer Related Pain
- NCT number
- NCT01205126
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 260 participants, actual
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Conditions
- Pain
- Interventions
- Hydromorphone HCl, Oxycodone HCl CR, Placebo
- First posted
- 2010-09-20
- Last updated
- 2014-02-03
- Results first posted
- 2013-11-25
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Worst Pain in the Past 24 Hours Assessed by Brief Pain Inventory (BPI) Short Form Questionnaire Score at Day 29 | Baseline and Day 29 | The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. Change in worst pain in the past 24 hours in BPI score was reported. The total score ranges from 0 to 10, wherein 0 indicates no pain and 10 indicates pain as bad as participants could imagine. |
| Secondary | Change From Baseline in Pain at Its Least, in the Past 24 Hours Assessed by BPI Short Form Questionnaire Score at Day 29 | Baseline and Day 29 | The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. Change in pain at its least, in the past 24 hours in BPI score was reported. The total score ranges from 0 to 10, wherein 0 indicates no pain and 10 indicates pain as bad as participants could imagine. |
| Secondary | Change From Baseline in Average Pain, in the Past 24 Hours Assessed by BPI Short Form Questionnaire Score at Day 29 | Baseline and Day 29 | The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. Change in average pain in the past 24 hours, in BPI score was reported. The score ranges from 0 to 10 wherein, 0 indicates no pain and 10 indicates pain as bad as participants could imagine. |
| Secondary | Change From Baseline in Pain Right Now Assessed by BPI Short Form Questionnaire Score at Day 29 | Baseline and Day 29 | The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. Change in Pain Right now in BPI was reported. The score ranges from 0=no pain to 10=pain as bad as participants could imagine. |
| Secondary | Change From Baseline in Pain Relief, in the Past 24 Hour Recorded Assessed by BPI Short Form Questionnaire at Day 29 | Baseline and Day 29 | The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. BPI comprises of total 9 items in total, and the 8th item consisting of 7 sub-items is a question asking the degree of disturbance due to pain. The score ranges from 0% to 100%, wherein 0% indicates no relief and 100% indicates complete relief. |
| Secondary | Breakthrough Pain Medication (Rescue Medication) Doses Taken | Baseline up to Day 29 | Any breakthrough pain medication taken during the overall study was reported. Morphine hydrochloride was used as a rescue medication in case of breakthrough pain. |
Source ClinicalTrials.gov
Outcomes6
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 Worst Pain in the Past 24 Hours Assessed by Brief Pain Inventory (BPI) Short Form Questionnaire Score at Day 29 | Baseline and Day 29 | Per protocol set (PPS) included all randomly assigned participants who had completed all efficacy evaluations, and participants who prematurely discontinued the study due to lack of efficacy were also included. Redefined last observation carried forward (LOCF) was applied. Redefined LOCF is LOCF prior to over dose rescue medication. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Pain at Its Least, in the Past 24 Hours Assessed by BPI Short Form Questionnaire Score at Day 29 | Baseline and Day 29 | The PPS included all randomly assigned participants who had completed all efficacy evaluations, have good compliance to the protocol without major protocol violations specified and who prematurely discontinued the study due to lack of efficacy were also included. Redefined LOCF was applied. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Average Pain, in the Past 24 Hours Assessed by BPI Short Form Questionnaire Score at Day 29 | Baseline and Day 29 | The PPS included all randomly assigned participants who had completed all efficacy evaluations, have good compliance to the protocol without major protocol violations specified and who prematurely discontinued the study due to lack of efficacy were also included. Redefined LOCF was applied. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Pain Right Now Assessed by BPI Short Form Questionnaire Score at Day 29 | Baseline and Day 29 | The PPS included all randomly assigned participants who had completed all efficacy evaluations, have good compliance to the protocol without major protocol violations specified and who prematurely discontinued the study due to lack of efficacy were also included. Redefined LOCF was applied. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Pain Relief, in the Past 24 Hour Recorded Assessed by BPI Short Form Questionnaire at Day 29 | Baseline and Day 29 | The PPS included all randomly assigned participants who had completed all efficacy evaluations, have good compliance to the protocol without major protocol violations specified and who prematurely discontinued the study due to lack of efficacy were also included. Redefined LOCF was applied. | Units on a scale | MEAN |
| SECONDARY | Breakthrough Pain Medication (Rescue Medication) Doses Taken | Baseline up to Day 29 | The PPS included all randomly assigned participants who had completed all efficacy evaluations, have good compliance to the protocol without major protocol violations specified and who prematurely discontinued the study due to lack of efficacy. Redefined LOCF was applied. Here 'N' =number of participants who were evaluated for this outcome measure. | Doses | 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 Baseline in Worst Pain in the Past 24 Hours Assessed by Brief Pain Inventory (BPI) Short Form Questionnaire Score at Day 29 | Hydromorphone Hydrochloride (HCl) | Baseline | 6.7 | Standard Deviation 1.80 | Units on a scale |
| Change From Baseline in Worst Pain in the Past 24 Hours Assessed by Brief Pain Inventory (BPI) Short Form Questionnaire Score at Day 29 | Oxycodone HCl Controlled Release (CR) | Baseline | 6.9 | Standard Deviation 1.65 | Units on a scale |
| Change From Baseline in Worst Pain in the Past 24 Hours Assessed by Brief Pain Inventory (BPI) Short Form Questionnaire Score at Day 29 | Hydromorphone Hydrochloride (HCl) | Change at Day 29 | -1.8 | Standard Deviation 2.79 | Units on a scale |
| Change From Baseline in Worst Pain in the Past 24 Hours Assessed by Brief Pain Inventory (BPI) Short Form Questionnaire Score at Day 29 | Oxycodone HCl Controlled Release (CR) | Change at Day 29 | -1.8 | Standard Deviation 2.95 | Units on a scale |
| Change From Baseline in Pain at Its Least, in the Past 24 Hours Assessed by BPI Short Form Questionnaire Score at Day 29 | Hydromorphone Hydrochloride (HCl) | Baseline | 2.4 | Standard Deviation 1.63 | Units on a scale |
| Change From Baseline in Pain at Its Least, in the Past 24 Hours Assessed by BPI Short Form Questionnaire Score at Day 29 | Oxycodone HCl Controlled Release (CR) | Baseline | 2.3 | Standard Deviation 1.37 | Units on a scale |
| Change From Baseline in Pain at Its Least, in the Past 24 Hours Assessed by BPI Short Form Questionnaire Score at Day 29 | Hydromorphone Hydrochloride (HCl) | Change at Day 29 | -0.8 | Standard Deviation 1.59 | Units on a scale |
| Change From Baseline in Pain at Its Least, in the Past 24 Hours Assessed by BPI Short Form Questionnaire Score at Day 29 | Oxycodone HCl Controlled Release (CR) | Change at Day 29 | -0.5 | Standard Deviation 2.20 | Units on a scale |
| Change From Baseline in Average Pain, in the Past 24 Hours Assessed by BPI Short Form Questionnaire Score at Day 29 | Hydromorphone Hydrochloride (HCl) | Baseline | 4.7 | Standard Deviation 1.35 | Units on a scale |
| Change From Baseline in Average Pain, in the Past 24 Hours Assessed by BPI Short Form Questionnaire Score at Day 29 | Oxycodone HCl Controlled Release (CR) | Baseline | 4.7 | Standard Deviation 1.46 | Units on a scale |
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 |
|---|---|---|---|---|
| Titration Phase | STARTED | Hydromorphone Hydrochloride (HCl) | 130 | |
| Titration Phase | STARTED | Oxycodone HCl Controlled Release (CR) | 130 | |
| Titration Phase | COMPLETED | Hydromorphone Hydrochloride (HCl) | 107 | |
| Titration Phase | COMPLETED | Oxycodone HCl Controlled Release (CR) | 111 | |
| Titration Phase | NOT COMPLETED | Hydromorphone Hydrochloride (HCl) | 23 | |
| Titration Phase | NOT COMPLETED | Oxycodone HCl Controlled Release (CR) | 19 | |
| Between Titration & Maintenance Phase | STARTED | Hydromorphone Hydrochloride (HCl) | 107 | |
| Between Titration & Maintenance Phase | STARTED | Oxycodone HCl Controlled Release (CR) | 111 | |
| Between Titration & Maintenance Phase | COMPLETED | Hydromorphone Hydrochloride (HCl) | 107 | |
| Between Titration & Maintenance Phase | COMPLETED | Oxycodone HCl Controlled Release (CR) | 107 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events92
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 | Bone marrow failure | Blood and lymphatic system disorders | Hydromorphone Hydrochloride (HCl) | 9 | 128 | |
| other | Bone marrow failure | Blood and lymphatic system disorders | Oxycodone HCl Controlled Release (CR) | 9 | 126 | |
| other | Anaemia | Blood and lymphatic system disorders | Hydromorphone Hydrochloride (HCl) | 11 | 128 | |
| other | Anaemia | Blood and lymphatic system disorders | Oxycodone HCl Controlled Release (CR) | 11 | 126 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Hydromorphone Hydrochloride (HCl) | 4 | 128 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Oxycodone HCl Controlled Release (CR) | 7 | 126 | |
| other | Abdominal distension | Gastrointestinal disorders | Hydromorphone Hydrochloride (HCl) | 7 | 128 | |
| other | Abdominal distension | Gastrointestinal disorders | Oxycodone HCl Controlled Release (CR) | 7 | 126 | |
| other | Constipation | Gastrointestinal disorders | Hydromorphone Hydrochloride (HCl) | 43 | 128 | |
| other | Constipation | Gastrointestinal disorders | Oxycodone HCl Controlled Release (CR) | 45 | 126 |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Hydromorphone Hydrochloride (HCl) | ||
| Total, all-cause mortality | Oxycodone HCl Controlled Release (CR) | ||
| Total, other adverse events | Hydromorphone Hydrochloride (HCl) | 102 | 128 |
| Total, other adverse events | Oxycodone HCl Controlled Release (CR) | 107 | 126 |
| Total, serious adverse events | Hydromorphone Hydrochloride (HCl) | 11 | 128 |
| Total, serious adverse events | Oxycodone HCl Controlled Release (CR) | 18 | 126 |
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 |
|---|
| Hydromorphone Hydrochloride (HCl) vs Oxycodone HCl Controlled Release (CR): 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/NCT01205126
GET https://conductscience.org/api/trials/v1/NCT01205126/results?page=2