Trial · NCT01675622
Immediate-Release Oxycodone Capsules Study in Cancer Pain
NCT01675622, Phase 3, Completed, Mundipharma (China) Pharmaceutical Co. Ltd; results first posted 2018-05-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Immediate-Release Oxycodone Capsules Study in Cancer Pain. Trials, record NCT01675622. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01675622
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Immediate-Release Oxycodone Capsules Study in Cancer Pain
- NCT number
- NCT01675622
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 242 participants, actual
- Lead sponsor
- Mundipharma (China) Pharmaceutical Co. Ltd
- Conditions
- Cancer
- Interventions
- Oxycodone, Morphine
- First posted
- 2012-08-30
- Last updated
- 2018-05-21
- Results first posted
- 2018-05-21
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Numerical Rating Scale (NRS) | baseline up to 5-8 days (double blind period) | The numerical rating scale is the tool to assess pain level using a numerical rating scale. The primary outcome measurement is the average change of NRS score after double blind treatment between the two treatment groups. The NRS evaluates the pain level using number scale from 0 to 10. 0 means not painful and 10 means extremely painful. 1 to 3 is lightly pain, 4-6 is moderate pain and 7 to 10 is severe pain. There is no subscales used for NRS reporting. |
| Secondary | The Average Dose of Study Medicine Used During Double Blind Treatment Period | baseline up to 5-8 days (double blind period) | the average dose of study medicine used during double blind treatment period between the two treatment groups. |
| Secondary | Brief Pain Inventory (BPI) Change From Baseline to After Double Blind Period | baseline up to 5-8 days (double blind period) | The secondary outcome measurement is the change between BPI score at baseline and after completion of double blind treatment between the two treatment groups. The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. This tool measures the worst/least pain in the passed 24 hours, and the average/current pain in last 24 hours. The scale is numerically from 0 to 10. 0 means not painful, 10 means extremely painful. The BPI is the average number of above 4 BPI Pain Items. |
| Secondary | Times of Breakthrough Pain Occurrence | Within 8 days after baseline | the times of breakthrough pain occurrence during double blind treatment phase between the two treatment groups |
| Secondary | Patient Assessments of Satisfaction for Pain Management | baseline up to 19-22 days (open label treatment) | the number of patients of satisfaction for pain management between the two treatment groups at the end of double blind treatment and the open label treatment period. |
| Secondary | Average Number of Titrations | baseline up to 1-3 days(double blind period) | the average times to change the dose in order to find the proper dose between two treatment groups |
| Secondary | Brief Pain Inventory (BPI) Change From Baseline to Open Label Treatment | baseline up to 19-22 days (open label treatment) | The secondary outcome measurement is the change of BPI score from baseline to the end of open label treatment between the two treatment groups. The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. This tool measures the worst/least pain in passed 24 hours, and the average/current pain in last 24 hours. The scale is numerically from 0 to 10. 0 means not painful, 10 means extremely painful. The BPI is the average number of above 4 BPI Pain Items. |
| Secondary | the Total Dose of Rescue Medicine for Breakthrough Pain. | baseline up to 22 days (double blind period) | the total dose of rescue medicine for breakthrough pain during double blind phase between the two treatment groups |
| Secondary | Degree of Pain Relief Within 24hrs After Treatment | baseline up to 5-8 days (double blind period) | Brief Pain Inventory (BPI) Change From Baseline to After Double Blind Period. The BPI is the average number of above 4 BPI Pain Items. For the degree of pain relief within 24hrs after treatment, 0 means zero relief and 100 means completely relief with unit of percentage(%). |
| Secondary | Brief Pain Inventory (BPI) Change From Baseline to Open Label Treatment | baseline up to 19-22 days (open label treatment) | For the degree of pain relief within 24hrs after treatment, 0 means zero relief and 100 means completely relief with unit of percentage(%). |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Numerical Rating Scale (NRS) | baseline up to 5-8 days (double blind period) | scores on a scale | MEAN | |
| SECONDARY | The Average Dose of Study Medicine Used During Double Blind Treatment Period | baseline up to 5-8 days (double blind period) | The average total dosage during double-blind treatment was defined as a primary efficacy endpoint in the protocol, but this study was a non-inferiority study, and non-inferiority analysis could not be performed in average total dosage in data processing and statistics. | mg | MEAN |
| SECONDARY | Brief Pain Inventory (BPI) Change From Baseline to After Double Blind Period | baseline up to 5-8 days (double blind period) | scores on a scale | MEAN | |
| SECONDARY | Times of Breakthrough Pain Occurrence | Within 8 days after baseline | breakthrough pain events | NUMBER | |
| SECONDARY | Patient Assessments of Satisfaction for Pain Management | baseline up to 19-22 days (open label treatment) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Average Number of Titrations | baseline up to 1-3 days(double blind period) | Dosing change frequency for complete titration | dose changes | MEAN |
| SECONDARY | Brief Pain Inventory (BPI) Change From Baseline to Open Label Treatment | baseline up to 19-22 days (open label treatment) | scores on a scale | MEAN | |
| SECONDARY | the Total Dose of Rescue Medicine for Breakthrough Pain. | baseline up to 22 days (double blind period) | The double-blind titration period was the dose adjusting phase, so breakthrough pain occurrences in this period were not included in statistical analysis. After titration was completed, subjects entered into maintenance treatment with the titrated dose. | mg | MEAN |
| SECONDARY | Degree of Pain Relief Within 24hrs After Treatment | baseline up to 5-8 days (double blind period) | percentage of pain relief | MEAN | |
| SECONDARY | Brief Pain Inventory (BPI) Change From Baseline to Open Label Treatment | baseline up to 19-22 days (open label treatment) | percentage of pain relief | MEAN |
Source ClinicalTrials.gov
Results by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Numerical Rating Scale (NRS) | Oxycodone Capsules for Cancer Pain | 3.91 | Standard Deviation 2.31 | scores on a scale | |
| Numerical Rating Scale (NRS) | Morphine Tablets for Cancer Pain | 3.87 | Standard Deviation 2.22 | scores on a scale | |
| The Average Dose of Study Medicine Used During Double Blind Treatment Period | Oxycodone Capsules for Cancer Pain | Average total dosage during double-blind titration | 83.29 | Standard Deviation 82.87 | mg |
| The Average Dose of Study Medicine Used During Double Blind Treatment Period | Morphine Tablets for Cancer Pain | Average total dosage during double-blind titration | 141.61 | Standard Deviation 112.10 | mg |
| The Average Dose of Study Medicine Used During Double Blind Treatment Period | Oxycodone Capsules for Cancer Pain | Ave. total dosage during double-blind maintenance | 167.41 | Standard Deviation 103.92 | mg |
| The Average Dose of Study Medicine Used During Double Blind Treatment Period | Morphine Tablets for Cancer Pain | Ave. total dosage during double-blind maintenance | 308.63 | Standard Deviation 189.93 | mg |
| Brief Pain Inventory (BPI) Change From Baseline to After Double Blind Period | Oxycodone Capsules for Cancer Pain | Highest pain intensity in 24 hrs | 4.25 | Standard Deviation 1.98 | scores on a scale |
| Brief Pain Inventory (BPI) Change From Baseline to After Double Blind Period | Morphine Tablets for Cancer Pain | Highest pain intensity in 24 hrs | 4.03 | Standard Deviation 2.20 | scores on a scale |
| Brief Pain Inventory (BPI) Change From Baseline to After Double Blind Period | Oxycodone Capsules for Cancer Pain | Lowest pain intensity in 24 hrs | 2.62 | Standard Deviation 2.08 | scores on a scale |
| Brief Pain Inventory (BPI) Change From Baseline to After Double Blind Period | Morphine Tablets for Cancer Pain | Lowest pain intensity in 24 hrs | 2.53 | Standard Deviation 1.98 | scores on a scale |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Oxycodone Capsules for Cancer Pain | 122 | |
| Overall Study | STARTED | Morphine Tablets for Cancer Pain | 120 | |
| Overall Study | COMPLETED | Oxycodone Capsules for Cancer Pain | 96 | |
| Overall Study | COMPLETED | Morphine Tablets for Cancer Pain | 96 | |
| Overall Study | NOT COMPLETED | Oxycodone Capsules for Cancer Pain | 26 | |
| Overall Study | NOT COMPLETED | Morphine Tablets for Cancer Pain | 24 |
Source ClinicalTrials.gov
Adverse events38
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 | Constipation | Gastrointestinal disorders | Oxycodone Capsules for Cancer Pain | 38 | 120 | 41 |
| other | Constipation | Gastrointestinal disorders | Morphine Tablets for Cancer Pain | 43 | 118 | 47 |
| other | Nausea | Gastrointestinal disorders | Oxycodone Capsules for Cancer Pain | 25 | 120 | 31 |
| other | Nausea | Gastrointestinal disorders | Morphine Tablets for Cancer Pain | 26 | 118 | 30 |
| other | Vomiting | Gastrointestinal disorders | Oxycodone Capsules for Cancer Pain | 25 | 120 | 27 |
| other | Vomiting | Gastrointestinal disorders | Morphine Tablets for Cancer Pain | 24 | 118 | 25 |
| other | Dizziness | Nervous system disorders | Oxycodone Capsules for Cancer Pain | 9 | 120 | 10 |
| other | Dizziness | Nervous system disorders | Morphine Tablets for Cancer Pain | 6 | 118 | 6 |
| other | Fever | Immune system disorders | Oxycodone Capsules for Cancer Pain | 8 | 120 | 9 |
| other | Fever | Immune system disorders | Morphine Tablets for Cancer Pain | 4 | 118 | 6 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oxycodone Capsules for Cancer Pain | 2 | 120 |
| Total, all-cause mortality | Morphine Tablets for Cancer Pain | 2 | 118 |
| Total, other adverse events | Oxycodone Capsules for Cancer Pain | 76 | 120 |
| Total, other adverse events | Morphine Tablets for Cancer Pain | 75 | 118 |
| Total, serious adverse events | Oxycodone Capsules for Cancer Pain | 4 | 120 |
| Total, serious adverse events | Morphine Tablets for Cancer Pain | 2 | 118 |
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 Capsules for Cancer Pain vs Morphine Tablets for Cancer Pain: deaths from any cause | Trial comparisons |
| Oxycodone Capsules for Cancer Pain vs Morphine Tablets for Cancer Pain: 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/NCT01675622
GET https://conductscience.org/api/trials/v1/NCT01675622/results?page=2