Trial · NCT02362672
Efficacy and Safety Study of NKTR-181 in Opioid-Naive Subjects With Low Back Pain
NCT02362672, Phase 3, Completed, Nektar Therapeutics; results first posted 2020-09-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of NKTR-181 in Opioid-Naive Subjects With Low Back Pain. Trials, record NCT02362672. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02362672
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of NKTR-181 in Opioid-Naive Subjects With Low Back Pain
- NCT number
- NCT02362672
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,189 participants, actual
- Lead sponsor
- Nektar Therapeutics
- Conditions
- Low Back Pain, Chronic Pain
- Interventions
- NKTR-181 BID tablets, Placebo to match NKTR-181 BID tablets
- First posted
- 2015-02-13
- Last updated
- 2020-09-16
- Results first posted
- 2020-09-16
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Change in Weekly (ie, 7-day Average) Pain Score at the End of Double-blind, Randomized Treatment Period, Relative to the Weekly Score at the End of Titration (Double-blind Baseline) | 12 Weeks of randomized double blinded period | The daily pain intensity is an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain). |
| Secondary | Responder Analysis Based on Percent Reduction in Pain Intensity | Screening Baseline through Week 12 | A responder is defined by the Sponsor as a randomized subject who completes the double-blind Randomized Treatment Period and experiences improvement in the Week 12 Weekly Pain Score from Screening Pain Score. This includes the proportion of responders with at least 30% and at least 50% reduction in pain intensity. |
| Secondary | Patient Global Impression of Change (PGIC): Number of Responders | Screening Baseline through Week 12 | The PGIC assesses the change in overall status relative to the initiation of the treatment. The scale measures global change of overall status on a 7-point scale (1 = No change (or condition has got worse), 2 = Almost the same, 3 = A little better, 4 = Somewhat better, 5 = Moderately better, 6 = Better, 7 = A great deal better). The proportion of subjects responding " A great deal better " and "better" was summarized by treatment group. |
| Secondary | Change in Sleep Quality in the Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R) | Screening Baseline through Week 12 | The MOS Sleep Scale measure sleep parameters contains 12 items. Eleven of them scored using a 5-point response scale and across 5 dimensions of sleep, including disturbance (4 items), sleep problems index (9 items), somnolence (3 items), adequacy (2 items), and respiratory impairments (2 items). The original survey items are converted to a 0 to 100 range (by Converting 1 to 0, 2 to 25, 3 to 50, 4 to 75, and 5 to 100). Items in each dimension (disturbance, sleep problems index, somnolence, adequacy, respiratory impairments) of sleep are averaged together to create the score for the scale. The range of each sleep dimension is from 0 to 100. Higher score of sleep disturbance, somnolence, sleep indices, and respiratory impairments indicates relatively worse sleep problem, whereas lower scores for sleep adequacy indicate worse sleep problems. |
| Secondary | Change in Sleep Quantity Measure in Hours in the Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R) | Screening Baseline through Week 12 | The 12 items of the MOS Sleep Scale measure sleep parameters across 6 dimensions of sleep, including disturbance (4 items), sleep problems index (9 items), quantity (1 item), somnolence (3 items), adequacy (2 items), and respiratory impairments (2 items). One of the 12 items, Sleep quantity, records the actual number of hours slept. Reported here is the sleep quantity. |
| Secondary | Change in Roland Morris Disability Questionnaire (RMDQ) | Screening Baseline through Week 12 | The RMDQ contains 24 items that is used to quantify the impact of low back pain on subject's ability to perform daily activities, mood and sleep. The questionnaire consists of 24 statements derived from the Sickness Impact Profile, with the addition of the phrase "because of my back." The questionnaire covers the areas of mobility, self-care, and sleeping. The RMDQ score is the total number of items checked which is from a minimum of 0 to a maximum of 24; the greater the score the grater the physical disability due to lower back 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 | The Change in Weekly (ie, 7-day Average) Pain Score at the End of Double-blind, Randomized Treatment Period, Relative to the Weekly Score at the End of Titration (Double-blind Baseline) | 12 Weeks of randomized double blinded period | The analysis set (N=610) is the intention-to-treat population, which was defined as all randomized subjects | units on a scale | MEAN |
| SECONDARY | Responder Analysis Based on Percent Reduction in Pain Intensity | Screening Baseline through Week 12 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Patient Global Impression of Change (PGIC): Number of Responders | Screening Baseline through Week 12 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change in Sleep Quality in the Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R) | Screening Baseline through Week 12 | The MOS Sleep-R was analyzed and presented as a change from Screening Baseline to Week 12 in double blinded treatment period. Subjects who discontinued from treatment early were not included in this analysis. | units on a scale | MEAN |
| SECONDARY | Change in Sleep Quantity Measure in Hours in the Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R) | Screening Baseline through Week 12 | hours | MEAN | |
| SECONDARY | Change in Roland Morris Disability Questionnaire (RMDQ) | Screening Baseline through Week 12 | The RMDQ was analyzed and presented as a change from Screening Baseline to Week 12 in double blinded treatment period. Subjects who discontinued from treatment early were not included in this analysis. | units on a scale | 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 |
|---|---|---|---|---|---|
| The Change in Weekly (ie, 7-day Average) Pain Score at the End of Double-blind, Randomized Treatment Period, Relative to the Weekly Score at the End of Titration (Double-blind Baseline) | NKTR-181 | 0.9 | Standard Error 0.11 | units on a scale | |
| The Change in Weekly (ie, 7-day Average) Pain Score at the End of Double-blind, Randomized Treatment Period, Relative to the Weekly Score at the End of Titration (Double-blind Baseline) | Placebo | 1.5 | Standard Error 0.11 | units on a scale | |
| Responder Analysis Based on Percent Reduction in Pain Intensity | NKTR-181 | Subjects with 30% improvement | 220 | Participants | |
| Responder Analysis Based on Percent Reduction in Pain Intensity | Placebo | Subjects with 30% improvement | 172 | Participants | |
| Responder Analysis Based on Percent Reduction in Pain Intensity | NKTR-181 | Subjects with 50% improvement | 158 | Participants | |
| Responder Analysis Based on Percent Reduction in Pain Intensity | Placebo | Subjects with 50% improvement | 114 | Participants | |
| Patient Global Impression of Change (PGIC): Number of Responders | NKTR-181 | 159 | Participants | ||
| Patient Global Impression of Change (PGIC): Number of Responders | Placebo | 100 | Participants | ||
| Change in Sleep Quality in the Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R) | NKTR-181 | Sleep Disturbance | -16.7 | Standard Deviation 23.9 | units on a scale |
| Change in Sleep Quality in the Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R) | Placebo | Sleep Disturbance | -9.5 | Standard Deviation 22.8 | 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 | NKTR-181 (Open-label Titration Phase) | 1,189 | |
| Titration Phase | STARTED | NKTR-181 (Double-blind Treatment Phase) | 0 | |
| Titration Phase | STARTED | Placebo (Double-blind Treatment Phase) | 0 | |
| Titration Phase | COMPLETED | NKTR-181 (Open-label Titration Phase) | 610 | |
| Titration Phase | COMPLETED | NKTR-181 (Double-blind Treatment Phase) | 0 | |
| Titration Phase | COMPLETED | Placebo (Double-blind Treatment Phase) | 0 | |
| Titration Phase | NOT COMPLETED | NKTR-181 (Open-label Titration Phase) | 579 | |
| Titration Phase | NOT COMPLETED | NKTR-181 (Double-blind Treatment Phase) | 0 | |
| Titration Phase | NOT COMPLETED | Placebo (Double-blind Treatment Phase) | 0 | |
| Double-blind Maintenance Phase | STARTED | NKTR-181 (Open-label Titration Phase) | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events93
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 | NKTR-181 (Titration Phase) | 425 | 1,189 | |
| other | Constipation | Gastrointestinal disorders | NKTR-181 (Double-blind Treatment Phase) | 27 | 309 | |
| other | Constipation | Gastrointestinal disorders | Placebo (Double-blind Treatment Phase) | 9 | 301 | |
| other | Nausea | Gastrointestinal disorders | NKTR-181 (Titration Phase) | 176 | 1,189 | |
| other | Nausea | Gastrointestinal disorders | NKTR-181 (Double-blind Treatment Phase) | 32 | 309 | |
| other | Nausea | Gastrointestinal disorders | Placebo (Double-blind Treatment Phase) | 18 | 301 | |
| other | Vomiting | Gastrointestinal disorders | NKTR-181 (Titration Phase) | 67 | 1,189 | |
| other | Vomiting | Gastrointestinal disorders | NKTR-181 (Double-blind Treatment Phase) | 15 | 309 | |
| other | Vomiting | Gastrointestinal disorders | Placebo (Double-blind Treatment Phase) | 5 | 301 | |
| other | Dry mouth | Gastrointestinal disorders | NKTR-181 (Titration Phase) | 66 | 1,189 |
1 to 10 of 93Source ClinicalTrials.gov
See all 93 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NKTR-181 (Titration Phase) | ||
| Total, all-cause mortality | NKTR-181 (Double-blind Treatment Phase) | ||
| Total, all-cause mortality | Placebo (Double-blind Treatment Phase) | ||
| Total, other adverse events | NKTR-181 (Titration Phase) | 803 | 1,189 |
| Total, other adverse events | NKTR-181 (Double-blind Treatment Phase) | 111 | 309 |
| Total, other adverse events | Placebo (Double-blind Treatment Phase) | 66 | 301 |
| Total, serious adverse events | NKTR-181 (Titration Phase) | 9 | 1,189 |
| Total, serious adverse events | NKTR-181 (Double-blind Treatment Phase) | 5 | 309 |
| Total, serious adverse events | Placebo (Double-blind Treatment Phase) | 6 | 301 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30747908 | RESULT |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| NKTR-181 vs Placebo: Patient Global Impression of Change (PGIC): Number of Responders |
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/NCT02362672
GET https://conductscience.org/api/trials/v1/NCT02362672/results?page=2