Trial · NCT00478023
A Study to Evaluate the Efficacy and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain After Abdominal Hysterectomy
NCT00478023, Phase 3, Completed, Grünenthal GmbH; results first posted 2010-01-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate the Efficacy and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain After Abdominal Hysterectomy. Trials, record NCT00478023. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00478023
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain After Abdominal Hysterectomy
- NCT number
- NCT00478023
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 854 participants, actual
- Lead sponsor
- Grünenthal GmbH
- Conditions
- Hysterectomy, Postoperative
- Interventions
- Morphine, CG5503 IR, CG5503 IR, CG5503 IR, Placebo
- First posted
- 2007-05-24
- Last updated
- 2019-10-28
- Results first posted
- 2010-01-27
- Limitations and caveats
- Approval to conduct the trial was obtained in Slovenia. No Slovenian subjects were exposed to study drug.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity. | Baseline to 24 hours after first intake of study drug | Pain Intensity assessed at predefined time points over a 24 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates "no pain" and a score of ten indicates "pain as bad as you can imagine". Differences calculated as \[baseline-post baseline\] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID24) is from -240 (indicative of an increase in pain) to 240 (indicative of a decrease in pain, assuming patients start with a baseline value of 10 and all subsequent values will be 0). |
| Secondary | Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity | Baseline value to 48 hours after first study drug intake. | Pain Intensity assessed at predefined time points over a 48 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates "no pain" and a score of ten indicates "pain as bad as you can imagine". Differences calculated as \[baseline-post baseline\] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID48) is from -480 (indicative of an increase in pain) to 480 (indicative of a decrease in pain, assuming patients start with a baseline value of 10 and all subsequent values will be 0). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity. | Baseline to 24 hours after first intake of study drug | Intention to Treat (ITT) and Last Observation Carried Forward (LOCF), i.e. all randomized subjects who received any amount of Investigational Medicinal Product (IMP = study drug) and had a non missing baseline pain assessment. | units on scale | MEAN |
| SECONDARY | Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity | Baseline value to 48 hours after first study drug intake. | Intention to treat (ITT) and Last Observation Carried Forward (LOCF), i.e. all randomized subjects who received any amount of Investigational Medicinal Product (IMP = study drug) and had a non missing baseline pain assessment. | units on scale | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity. | Morphine | 48.8 | Standard Deviation 41.0 | units on scale | |
| Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity. | CG5503 50mg | 49.0 | Standard Deviation 39.87 | units on scale | |
| Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity. | CG5503 75mg | 52.4 | Standard Deviation 41.85 | units on scale | |
| Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity. | CG5503 100mg | 52.9 | Standard Deviation 40.95 | units on scale | |
| Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity. | Placebo | 29.0 | Standard Deviation 44.98 | units on scale | |
| Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity | Morphine | 116.6 | Standard Deviation 87.10 | units on scale | |
| Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity | CG5503 50mg | 112.4 | Standard Deviation 87.32 | units on scale | |
| Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity | CG5503 75mg | 120.6 | Standard Deviation 87.35 | units on scale | |
| Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity | CG5503 100mg | 123.5 | Standard Deviation 83.50 | units on scale | |
| Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity | Placebo | 71.1 | Standard Deviation 101.17 | units on scale |
Source ClinicalTrials.gov
Participant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Morphine | 170 | |
| Overall Study | STARTED | CG5503 50mg | 168 | |
| Overall Study | STARTED | CG5503 75mg | 171 | |
| Overall Study | STARTED | CG5503 100mg | 176 | |
| Overall Study | STARTED | Placebo | 169 | |
| Overall Study | COMPLETED | Morphine | 135 | |
| Overall Study | COMPLETED | CG5503 50mg | 144 | |
| Overall Study | COMPLETED | CG5503 75mg | 151 | |
| Overall Study | COMPLETED | CG5503 100mg | 146 | |
| Overall Study | COMPLETED | Placebo | 114 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events75
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 | Nausea | Gastrointestinal disorders | Morphine | 31 | 170 | |
| other | Nausea | Gastrointestinal disorders | CG5503 50mg | 23 | 168 | |
| other | Nausea | Gastrointestinal disorders | CG5503 75mg | 33 | 171 | |
| other | Nausea | Gastrointestinal disorders | CG5503 100mg | 31 | 176 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 21 | 169 | |
| other | Constipation | Gastrointestinal disorders | Morphine | 13 | 170 | |
| other | Constipation | Gastrointestinal disorders | CG5503 50mg | 11 | 168 | |
| other | Constipation | Gastrointestinal disorders | CG5503 75mg | 10 | 171 | |
| other | Constipation | Gastrointestinal disorders | CG5503 100mg | 15 | 176 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 9 | 169 |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Morphine | ||
| Total, all-cause mortality | CG5503 50mg | ||
| Total, all-cause mortality | CG5503 75mg | ||
| Total, all-cause mortality | CG5503 100mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Morphine | 99 | 170 |
| Total, other adverse events | CG5503 50mg | 84 | 168 |
| Total, other adverse events | CG5503 75mg | 96 | 171 |
| Total, other adverse events | CG5503 100mg | 106 | 176 |
| Total, other adverse events | Placebo | 88 | 169 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
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.
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/NCT00478023
GET https://conductscience.org/api/trials/v1/NCT00478023/events?page=2