Trial · NCT01885182
Determine the Safety and Efficacy of Oxy/Nal Tablets Compared to Oxy PR in Subjects With Cancer Pain
NCT01885182, Phase 3, Completed, Mundipharma (China) Pharmaceutical Co. Ltd; results first posted 2019-09-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Determine the Safety and Efficacy of Oxy/Nal Tablets Compared to Oxy PR in Subjects With Cancer Pain. Trials, record NCT01885182. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01885182
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Determine the Safety and Efficacy of Oxy/Nal Tablets Compared to Oxy PR in Subjects With Cancer Pain
- NCT number
- NCT01885182
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 232 participants, actual
- Lead sponsor
- Mundipharma (China) Pharmaceutical Co. Ltd
- Conditions
- Cancer, Pain
- Interventions
- Oxycodone/Naloxone, Oxycodone
- First posted
- 2013-06-24
- Last updated
- 2019-10-04
- Results first posted
- 2019-09-16
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Change of BFI-Bowel Function Index at visit8 | Visit8, visit8 taking place at week 4 or after early discontinuation/withdrawal from study | BFI is the mean of NAS for the following items: * Ease of defecation * Feeling of incomplete bowel evacuation. * Personal judgment of constipation. NAS was a measure of 0-100 where 0 was easy/no difficulty/not at all and 100 was severe difficulty/very strong,total score range is 0-300.Do higher values represent a worse outcome. |
| Primary | The Change of BPI-SF at visit8 | Visit8, visit8 taking place at week 4 or after early discontinuation/withdrawal from study | Brief pain inventory short-form(BPI-SF) recorded at final visit assesses subject's average pain over the last 24 hours. score range is 0(no pain)-10(pain as bad as you can imagine).Do higher values represent a worse outcome. |
| Secondary | The Change of Symptoms of Constipation Based on Laxative Use From visit5 to visit8 | visit 5 (week 1) to visit8 (week 4 or early discontinue/withdrawal from study) | At Visit 5(day7) and visit8(day28) number of bisacodyl taken(Number of laxative tablets took during the last 7 days (per week) and Daily number of laxative tablets took during the last 7 days (per day)\*) for OXN PR and OXY PR groups. |
| Secondary | The Change of Rescue Medication Use From visit5 to visit8 | visit 5 (week 1) to visit8 (week 4 or early discontinue/withdrawal from study) | The average daily dose of rescue medication (Morphine Sulfate Tablet) for OXN PR group and OXY PR group at Visit 5(first week of double blind) and at Visit 8(last week of double blind). |
| Secondary | The Change of Modified Subjective Opiate Withdrawal Scale (SOWS) From Visit1 to visit3,visit1 to visit9 | Visit1(screening visit) to visit3 (day 1), visit1(screening visit) to visit9 (week 5) | to compare the Modified SOWS's Change from Visit 1(day-10-0) to Visit 3(day1),Change from Visit 1 to Visit 9(day35).The SOWS was scored as the total of the 15 symptoms. each symptoms score is 0(not at all)-4(extremely).total score range is 0-60.Do higher values represent a better outcome. |
| Secondary | To Assess Quality of Life Based on EQ-5D | Visit1(screening visit) to Visit8 (week 4 or after early discontinuation/withdrawal from study) | To assess quality of life based on EQ-5D by subjects evaluation via patient dairy.the quality of life based on EQ-5D at Visit1 (day-10-0) and end of treatment Visit8(day28). The scarc range is 0(the best state you can imagine)-100(the worst state you can imagine).Do higher values represent a worse outcome. |
| Secondary | The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit | visit2 (day 0) to visit8 (week 4 or early discontinue/withdrawal from study) | To compare the change of Brief pain inventory short-form (BPI-SF) 11 indivial items (except for pain in average) at visit2(day0) ,visit5(day7),visit6(day14),visit7(day21), visit8(day28). each item range (except for how much relief from treatment /medication last 24hours is 0-100%,do higher values represent a better outcome.) is 0-10, do higher values represent a worse outcome. |
| Secondary | The Change of Bowel Movement by Visit | visit2 (day 0) to visit8 (week 4 or early discontinue/withdrawal from study) | Number pf bowel movements(BM) and number of days the subjects had a bowel movement in the last 7 days before the study visit will be summarized at visit2(day0) ,visit5(day7),visit6(day14),visit7(day21), visit8(day28).. |
| Secondary | The Chage of Symptoms of Constipation Based on Laxative Use From visit5 to visit8 | visit 5 taking place at week 1 to visit8 taking place at week 4 or early discontinue/withdrawal from study where applicable | At Visit5(day7) and visit8(day28) number of bisacodyl taken(Number of laxative tablets took during the last 7 days (per week) and Daily number of laxative tablets took during the last 7 days (per day)\*) for OXN PR and OXY PR groups |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Change of BFI-Bowel Function Index at visit8 | Visit8, visit8 taking place at week 4 or after early discontinuation/withdrawal from study | below presents the mean BFI at final visit, primary analysis in FAP. | score on BFI | MEAN |
| PRIMARY | The Change of BPI-SF at visit8 | Visit8, visit8 taking place at week 4 or after early discontinuation/withdrawal from study | FAP | Score on BPI-Brief Pain Index | MEAN |
| SECONDARY | The Change of Symptoms of Constipation Based on Laxative Use From visit5 to visit8 | visit 5 (week 1) to visit8 (week 4 or early discontinue/withdrawal from study) | FAP | laxatives/week | MEAN |
| SECONDARY | The Change of Rescue Medication Use From visit5 to visit8 | visit 5 (week 1) to visit8 (week 4 or early discontinue/withdrawal from study) | FAP | Morphine Sulfate mg/day | MEAN |
| SECONDARY | The Change of Modified Subjective Opiate Withdrawal Scale (SOWS) From Visit1 to visit3,visit1 to visit9 | Visit1(screening visit) to visit3 (day 1), visit1(screening visit) to visit9 (week 5) | FAP | score on SOWS | MEAN |
| SECONDARY | To Assess Quality of Life Based on EQ-5D | Visit1(screening visit) to Visit8 (week 4 or after early discontinuation/withdrawal from study) | FAP | Score on EQ-5D | MEAN |
| SECONDARY | The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit | visit2 (day 0) to visit8 (week 4 or early discontinue/withdrawal from study) | FAP | score on BPI-SF | MEAN |
| SECONDARY | The Change of Bowel Movement by Visit | visit2 (day 0) to visit8 (week 4 or early discontinue/withdrawal from study) | FAP | Bowel movement/day | MEAN |
| SECONDARY | The Chage of Symptoms of Constipation Based on Laxative Use From visit5 to visit8 | visit 5 taking place at week 1 to visit8 taking place at week 4 or early discontinue/withdrawal from study where applicable | FAP | laxatives/day | MEAN |
Source ClinicalTrials.gov
Results by group164
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Change of BFI-Bowel Function Index at visit8 | Oxycodone/Naloxone | 48.3 | Standard Deviation 25.7 | score on BFI | |
| The Change of BFI-Bowel Function Index at visit8 | Oxycodone | 51.2 | Standard Deviation 26.4 | score on BFI | |
| The Change of BPI-SF at visit8 | Oxycodone/Naloxone | 3.7 | Standard Deviation 1.7 | Score on BPI-Brief Pain Index | |
| The Change of BPI-SF at visit8 | Oxycodone | 3.6 | Standard Deviation 2.0 | Score on BPI-Brief Pain Index | |
| The Change of Symptoms of Constipation Based on Laxative Use From visit5 to visit8 | Oxycodone/Naloxone | Weekly number of bisacodyl taken at Visit5 | 2.1 | Standard Deviation 2.6 | laxatives/week |
| The Change of Symptoms of Constipation Based on Laxative Use From visit5 to visit8 | Oxycodone | Weekly number of bisacodyl taken at Visit5 | 2.5 | Standard Deviation 2.6 | laxatives/week |
| The Change of Symptoms of Constipation Based on Laxative Use From visit5 to visit8 | Oxycodone/Naloxone | Weekly number of bisacodyl taken at Visit8 | 2.2 | Standard Deviation 2.9 | laxatives/week |
| The Change of Symptoms of Constipation Based on Laxative Use From visit5 to visit8 | Oxycodone | Weekly number of bisacodyl taken at Visit8 | 2.2 | Standard Deviation 2.8 | laxatives/week |
| The Change of Rescue Medication Use From visit5 to visit8 | Oxycodone/Naloxone | V5 | 18.5 | Standard Deviation 21.4 | Morphine Sulfate mg/day |
| The Change of Rescue Medication Use From visit5 to visit8 | Oxycodone | V5 | 13.9 | Standard Deviation 18.9 | Morphine Sulfate mg/day |
1 to 10 of 164Source ClinicalTrials.gov
See all 164 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Oxycodone/Naloxone | 117 | |
| Overall Study | STARTED | Oxycodone | 115 | |
| Overall Study | Safety Population | Oxycodone/Naloxone | 114 | |
| Overall Study | Safety Population | Oxycodone | 111 | |
| Overall Study | FAP Population | Oxycodone/Naloxone | 107 | |
| Overall Study | FAP Population | Oxycodone | 106 | |
| Overall Study | COMPLETED | Oxycodone/Naloxone | 83 | |
| Overall Study | COMPLETED | Oxycodone | 93 | |
| Overall Study | NOT COMPLETED | Oxycodone/Naloxone | 34 | |
| Overall Study | NOT COMPLETED | Oxycodone | 22 |
Source ClinicalTrials.gov
Adverse events76
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 | Vomiting | Gastrointestinal disorders | Oxycodone/Naloxone | 27 | 114 | 63 |
| other | Vomiting | Gastrointestinal disorders | Oxycodone | 22 | 111 | 57 |
| other | Abdominal distension | Gastrointestinal disorders | Oxycodone/Naloxone | 6 | 114 | 17 |
| other | Abdominal distension | Gastrointestinal disorders | Oxycodone | 6 | 111 | 17 |
| other | Nausea | Gastrointestinal disorders | Oxycodone/Naloxone | 9 | 114 | 13 |
| other | Nausea | Gastrointestinal disorders | Oxycodone | 12 | 111 | 19 |
| other | Pyrexia | General disorders | Oxycodone/Naloxone | 6 | 114 | 8 |
| other | Pyrexia | General disorders | Oxycodone | 6 | 111 | 13 |
| other | Abdominal pain upper | General disorders | Oxycodone/Naloxone | 1 | 114 | 14 |
| other | Abdominal pain upper | General disorders | Oxycodone | 2 | 111 | 5 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oxycodone/Naloxone | 8 | 114 |
| Total, all-cause mortality | Oxycodone | 4 | 111 |
| Total, other adverse events | Oxycodone/Naloxone | 72 | 114 |
| Total, other adverse events | Oxycodone | 76 | 111 |
| Total, serious adverse events | Oxycodone/Naloxone | 14 | 114 |
| Total, serious adverse events | Oxycodone | 12 | 111 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Oxycodone/Naloxone vs Oxycodone: deaths from any cause | Trial comparisons |
| Oxycodone/Naloxone vs Oxycodone: serious adverse events | 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/NCT01885182
GET https://conductscience.org/api/trials/v1/NCT01885182/results?page=2