Trial · NCT00986180
NUCYNTA (Tapentadol Immediate Release) Versus Oxycodone Immediate Release in the Treatment of Acute Low Back Pain
NCT00986180, Phase 3, Completed, Ortho-McNeil Janssen Scientific Affairs, LLC; results first posted 2012-02-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. NUCYNTA (Tapentadol Immediate Release) Versus Oxycodone Immediate Release in the Treatment of Acute Low Back Pain. Trials, record NCT00986180. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00986180
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- NUCYNTA (Tapentadol Immediate Release) Versus Oxycodone Immediate Release in the Treatment of Acute Low Back Pain
- NCT number
- NCT00986180
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 667 participants, actual
- Lead sponsor
- Ortho-McNeil Janssen Scientific Affairs, LLC
- Conditions
- Pain, Back Pain, Low Back Pain, Back Pain With Radiation
- Interventions
- NUCYNTA, Oxycodone IR
- First posted
- 2009-09-29
- Last updated
- 2012-12-19
- Results first posted
- 2012-02-29
- Limitations and caveats
There were 19 subjects either did not take medication or did not have verifiable drug exposure. 2 subjects were randomized in two different sites, only one site information were included. 1 subject were randomized in error.
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Sum of Pain Intensity Difference (SPID) for Low Back Pain - Summary Statistics at 120 Hours (With Imputation) | 0 hour (prior to first dose) and 120 hours | Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 120 hours. |
| Secondary | Sum of Pain Intensity Difference (SPID) for Low Back Pain - Summary Statistics at 2 Days (With Imputation) | Day 0 and Day 2 | Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 2 days. |
| Secondary | SPID for Low Back Pain - Summary Statistics at 3 Days (With Imputation) | Day 0 and Day 3 | Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 3 days. |
| Secondary | SPID for Low Back Pain - Summary Statistics at 10 Days (With Imputation) | Day 0 and Day 10 | Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 10 days. |
| Secondary | SPID for Index Leg Pain - Summary Statistics at 2 Days (With Imputation) | Day 0 and Day 2 | Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 2 days. |
| Secondary | SPID for Index Leg Pain - Summary Statistics at 3 Days (With Imputation) | Day 0 and Day 3 | Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 3 days. |
| Secondary | SPID for Index Leg Pain - Summary Statistics at 5 Days (With Imputation) | Day 0 and Day 5 | Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 5 days. |
| Secondary | SPID for Index Leg Pain - Summary Statistics at 10 Days (With Imputation) | Day 0 and Day 10 | Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 10 days. |
| Secondary | Total Pain Relief (TOTPAR) for Low Back Pain - Summary Statistics at 5 Days | Day 0 and Day 5 | Pain Relief - 5-Point Numerical Rating Scale, 0=None, 4=Complete. Total Pain Relief (TOTPAR) is a weighted sum of pain relieve over a specified time period, say 5 days. |
| Secondary | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Continuous Pain Day 5 | Day 0 and Day 5 | Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Continuous pain subscale descriptors include: throbbing pain, cramping pain, gnawing pain, aching pain, heavy pain, and tender. |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 registered outcomesOutcomes36
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 Difference (SPID) for Low Back Pain - Summary Statistics at 120 Hours (With Imputation) | 0 hour (prior to first dose) and 120 hours | Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS). | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Sum of Pain Intensity Difference (SPID) for Low Back Pain - Summary Statistics at 2 Days (With Imputation) | Day 0 and Day 2 | Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS). | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | SPID for Low Back Pain - Summary Statistics at 3 Days (With Imputation) | Day 0 and Day 3 | Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS). | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | SPID for Low Back Pain - Summary Statistics at 10 Days (With Imputation) | Day 0 and Day 10 | Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS). | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | SPID for Index Leg Pain - Summary Statistics at 2 Days (With Imputation) | Day 0 and Day 2 | Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS). | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | SPID for Index Leg Pain - Summary Statistics at 3 Days (With Imputation) | Day 0 and Day 3 | Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS). | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | SPID for Index Leg Pain - Summary Statistics at 5 Days (With Imputation) | Day 0 and Day 5 | Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS). | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | SPID for Index Leg Pain - Summary Statistics at 10 Days (With Imputation) | Day 0 and Day 10 | Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS). | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Total Pain Relief (TOTPAR) for Low Back Pain - Summary Statistics at 5 Days | Day 0 and Day 5 | Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS). | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Continuous Pain Day 5 | Day 0 and Day 5 | Intent-To-Treat Population (all randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain) and have both baseline and Day 5 SF-MPQ-2 measurement | Units on a Scale | MEAN |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 outcomesResults by group196
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 Difference (SPID) for Low Back Pain - Summary Statistics at 120 Hours (With Imputation) | NUCYNTA | 264.6 | Standard Error 11.43 | Units on a scale | |
| Sum of Pain Intensity Difference (SPID) for Low Back Pain - Summary Statistics at 120 Hours (With Imputation) | Oxycodone IR | 264.0 | Standard Error 11.22 | Units on a scale | |
| Sum of Pain Intensity Difference (SPID) for Low Back Pain - Summary Statistics at 2 Days (With Imputation) | NUCYNTA | 80.1 | Standard Error 4.34 | Units on a Scale | |
| Sum of Pain Intensity Difference (SPID) for Low Back Pain - Summary Statistics at 2 Days (With Imputation) | Oxycodone IR | 81.8 | Standard Error 4.26 | Units on a Scale | |
| SPID for Low Back Pain - Summary Statistics at 3 Days (With Imputation) | NUCYNTA | 137.2 | Standard Error 6.60 | Units on a scale | |
| SPID for Low Back Pain - Summary Statistics at 3 Days (With Imputation) | Oxycodone IR | 138.1 | Standard Error 6.47 | Units on a scale | |
| SPID for Low Back Pain - Summary Statistics at 10 Days (With Imputation) | NUCYNTA | 540.2 | Standard Error 21.23 | Units on a scale | |
| SPID for Low Back Pain - Summary Statistics at 10 Days (With Imputation) | Oxycodone IR | 538.6 | Standard Error 20.84 | Units on a scale | |
| SPID for Index Leg Pain - Summary Statistics at 2 Days (With Imputation) | NUCYNTA | 73.6 | Standard Error 4.34 | Units on a Scale | |
| SPID for Index Leg Pain - Summary Statistics at 2 Days (With Imputation) | Oxycodone IR | 72.1 | Standard Error 4.26 | Units on a Scale |
1 to 10 of 196Source ClinicalTrials.gov
See all 196 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | NUCYNTA | 321 | |
| Overall Study | STARTED | Oxycodone IR | 324 | |
| Overall Study | COMPLETED | NUCYNTA | 277 | |
| Overall Study | COMPLETED | Oxycodone IR | 268 | |
| Overall Study | NOT COMPLETED | NUCYNTA | 44 | |
| Overall Study | NOT COMPLETED | Oxycodone IR | 56 |
Source ClinicalTrials.gov
Adverse events24
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 | NUCYNTA | 51 | 321 | |
| other | Nausea | Gastrointestinal disorders | Oxycodone IR | 67 | 324 | |
| other | Vomiting | Gastrointestinal disorders | NUCYNTA | 51 | 321 | |
| other | Vomiting | Gastrointestinal disorders | Oxycodone IR | 80 | 324 | |
| other | Constipation | Gastrointestinal disorders | NUCYNTA | 7 | 321 | |
| other | Constipation | Gastrointestinal disorders | Oxycodone IR | 23 | 324 | |
| other | Dizziness | Nervous system disorders | NUCYNTA | 38 | 321 | |
| other | Dizziness | Nervous system disorders | Oxycodone IR | 34 | 324 | |
| other | Somnolence | Nervous system disorders | NUCYNTA | 26 | 321 | |
| other | Somnolence | Nervous system disorders | Oxycodone IR | 22 | 324 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NUCYNTA | ||
| Total, all-cause mortality | Oxycodone IR | ||
| Total, other adverse events | NUCYNTA | 141 | 321 |
| Total, other adverse events | Oxycodone IR | 165 | 324 |
| Total, serious adverse events | NUCYNTA | 2 | 321 |
| Total, serious adverse events | Oxycodone IR | 3 | 324 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23703422 | DERIVED |
Source PubMed
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 comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| NUCYNTA vs Oxycodone IR: Incidence of 50% Responders Without Nausea or Vomiting at Day 5 | Trial comparisons |
| NUCYNTA vs Oxycodone IR: Summary of Subjects Having Nausea as a Treatment-Emergent Adverse Event | Trial comparisons |
| NUCYNTA vs Oxycodone IR: Incidence of 30% Responders Without Nausea or Vomiting at Day 5 | Trial comparisons |
| NUCYNTA vs Oxycodone IR: Summary of Subjects Having Constipation as a Treatment-Emergent Adverse Event | Trial comparisons |
| NUCYNTA vs Oxycodone IR: Summary of Subjects Having Pruritus as a Treatment-Emergent Adverse Event | Trial comparisons |
| NUCYNTA vs Oxycodone IR: Summary of Subjects Having Vomiting as a Treatment-Emergent Adverse Event | Trial comparisons |
| NUCYNTA vs Oxycodone IR: 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
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GET https://conductscience.org/api/trials/v1/NCT00986180
GET https://conductscience.org/api/trials/v1/NCT00986180/registered?page=2