Trial · NCT02365636
A Study to Evaluate the Safety and Efficacy of Topically Applied TV 45070 Ointment in Patients With Postherpetic Neuralgia (PHN)
NCT02365636, Phase 2, Completed, Teva Branded Pharmaceutical Products R&D, Inc.; results first posted 2018-10-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Safety and Efficacy of Topically Applied TV 45070 Ointment in Patients With Postherpetic Neuralgia (PHN). Trials, record NCT02365636. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02365636
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety and Efficacy of Topically Applied TV 45070 Ointment in Patients With Postherpetic Neuralgia (PHN)
- NCT number
- NCT02365636
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 300 participants, actual
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Conditions
- Postherpetic Neuralgia
- Interventions
- TV-45070, Placebo
- First posted
- 2015-02-19
- Last updated
- 2021-11-09
- Results first posted
- 2018-10-23
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Week 4 in the Weekly Average of the Daily Average Numeric Rating Scale (NRS) Pain Scores Using a Mixed Model for Repeated Measures | Baseline (day -7 to day -1), Week 4 (day 22 to day 28) | The primary efficacy endpoint was the change from baseline to week 4 in the weekly average of the daily average NRS scores. The NRS is a widely-used, standard one-dimensional 11-point scale from 0=no pain to 10=worst pain imaginable as reported by patients. The daily average NRS scores is the average of the 2 NRS scores (recorded in the morning and evening) of average pain, defined as the patient-reported average pain intensity over the prior 12 hours. At least 1 of the 2 daily scores had to be recorded (non-missing) or the daily average was considered missing. Negative change from baseline values indicate a lessening of pain. The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the daily average NRS scores at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the daily average NRS scores as covariate; and patient as a random effect. |
| Secondary | Change From Baseline to Week 4 in the Weekly Average of the Average Numeric Rating Scale (NRS) Pain Scores Recorded in the Evening Using a Mixed Model for Repeated Measures | Baseline (day -7 to day -1), Week 4 (day 22 to day 28) | The NRS is a widely-used, standard one-dimensional 11-point scale from 0=no pain to 10=worst pain imaginable as reported by patients. The NRS pain scores recorded in the evening is defined as the patient-reported average pain intensity over the prior 12 hours. Negative change from baseline values indicate a lessening of pain. The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the evening NRS scores at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the evening NRS scores as covariate; and patient as a random effect. |
| Secondary | Change From Baseline to Week 4 in the Weekly Average of the Average Numeric Rating Scale (NRS) Pain Scores Recorded in the Morning Using a Mixed Model for Repeated Measures | Baseline (day -7 to day -1), Week 4 (day 22 to day 28) | The NRS is a widely-used, standard one-dimensional 11-point scale from 0=no pain to 10=worst pain imaginable as reported by patients. The NRS pain scores recorded in the morning is defined as the patient-reported average pain intensity over the prior 12 hours. Negative change from baseline values indicate a lessening of pain. The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the evening NRS scores at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of morning NRS scores as covariate; and patient as a random effect. |
| Secondary | Change From Baseline to Week 4 in the Weekly Average of the Worst Numeric Rating Scale (NRS) Pain Scores Recorded in the Evening Using a Mixed Model for Repeated Measures | Baseline (day -7 to day -1), Week 4 (day 22 to day 28) | The NRS is a widely-used, standard one-dimensional 11-point scale from 0=no pain to 10=worst pain imaginable as reported by patients. The worst pain is defined as the patient-reported worst pain intensity over the prior 24 hours. Negative change from baseline values indicate a lessening of pain. The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the worst pain NRS scores at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the evening NRS scores as covariate; and patient as a random effect. |
| Secondary | Percentage of Participants With >=30% and >=50% Improvement From Baseline in the Weekly Average of the Daily Average Numeric Rating Scale (NRS) Pain Scores at Week 4 Using a Mixed Model for Repeated Measures | Baseline (day -7 to day -1), Week 4 (day 22 to day 28) | The NRS is a 11-point scale from 0=no pain to 10=worst pain imaginable as reported by patients. The daily average NRS scores is the average of the 2 NRS scores (recorded in the morning and evening) of average pain, defined as the patient-reported average pain intensity over the prior 12 hours. Percent improvement is calculated as 100 × (the weekly average of the daily average NRS pain score at week 4 - weekly average of the daily average NRS pain scores at baseline /weekly average of the daily average NRS pain scores at baseline. Patients missing a week 4 average are considered non-responders (\<50% improvement or \<30% improvement). The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the daily average NRS scores at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the daily average NRS scores as covariate; and patient as a random effect. |
| Secondary | Change From Baseline to Weeks 2 and 4 in the Neuropathic Pain Symptom Inventory (NPSI) Total Score Using a Mixed Model for Repeated Measures (MMRM) | Baseline (day 1 prior to dosing), Weeks 2 (day 15) and Week 4 (day 29) | NPSI is a patient-reported questionnaire to evaluate the severity of different symptoms of neuropathic pain. The questionnaire contains 10 descriptors representing 5 distinct dimensions of pain: burning pain, deep pain, paroxysmal pain, evoked pain, and paresthesia/dysesthesia, plus 2 temporal items. Descriptors are scored from 0 through 10, where higher scores represent worse pain. The total score is the sum of the scores of the 10 descriptors (Bouhassira et al 2004). The total score ranges from 0 (no pain) through 100 (worst pain imaginable). If the score for one question was missing the total score was computed as 10 times sum of scores of 9 descriptors divided by 9. If more than one question was missing then the total score was missing. Negative change from baseline scores indicated less pain. The MMRM used pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. |
| Secondary | Change From Baseline to Week 4 in the Neuropathic Pain Impact on Quality of Life (NePIQoL) Total Score | Baseline (day 1), Week 4 (day 29) | NePIQoL is a questionnaire that contains 41 items to evaluate quality of life in patients with neuropathic pain. Each question has responses ranging from strongly agree or always to strongly disagree or never. Questions are scored on a 5-point scale from 1 through 5, where higher scores represent greater pain-related interference in quality of life. Total range is 41 (great quality of life) to 205 (worst quality of life). Negative change from baseline scores indicated an improving quality of life. |
| Secondary | Participants' Global Assess of Treatment as Measured by the Patient Global Impression of Change (PGIC) at Weeks 2 and 4 Using a Mixed Model for Repeated Measures (MMRM) | Weeks 2 (day 15) and Week 4 (day 29) | PGIC is a standardized self-report tool that measures the change in a patient's overall status rating since the start of treatment on 7-point scale (Hurst and Bolton 2004). The 7-point scale is defined as: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse. The MMRM used pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. |
| Secondary | Change From Baseline to Weeks 2 and 4 in the Daily Sleep Interference Scale (DSIS) Using a Mixed Model for Repeated Measures | Baseline (day 1 prior to dosing), Weeks 2 (day 15) and Week 4 (day 29) | DSIS is an 11-point scale that asks the patient to "select the number that best describes how much your pain has interfered with your sleep during the past 24 hours." Response options range from 0 (Did not interfere with sleep) to 10 (Completely interfered with sleep/unable to sleep due to pain). Negative change from baseline scores indicate improvement (lessening) of how much pain interfered with sleep. The MMRM used pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. |
| Secondary | Kaplan-Meier Estimates for First Time to Reach 30% or More Sustained Improvement in Weekly Average of the Daily Average NRS Pain Scores | Baseline (days -7 to -1), Week 1 (days 1-7), Week 2 (day 8-14), Week 3 (days 15-21), Week 4 (days 22-29) | Percent improvement is calculated as 100\*(the weekly average of the daily average NRS pain score - weekly average of the daily average NRS pain scores at baseline \[days -7 to -1\])/weekly average of the daily average NRS pain scores at baseline. Patients who do not reach \>= 30% improvement are censored at their last non-missing weekly average. Patients who reach \>= 30% improvement, but the improvement is not sustained through the end of the treatment period are censored at their last non-missing weekly average. For patients who reach \>= 30% improvement that is sustained through the end through the end of the of the treatment, the time \>= 30% improvement is first reached is used. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Week 4 in the Weekly Average of the Daily Average Numeric Rating Scale (NRS) Pain Scores Using a Mixed Model for Repeated Measures | Baseline (day -7 to day -1), Week 4 (day 22 to day 28) | Full analysis set; patients from one site are excluded due to lack of data integrity. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 4 in the Weekly Average of the Average Numeric Rating Scale (NRS) Pain Scores Recorded in the Evening Using a Mixed Model for Repeated Measures | Baseline (day -7 to day -1), Week 4 (day 22 to day 28) | Full analysis set. Participants from one site are excluded due to lack of data integrity. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 4 in the Weekly Average of the Average Numeric Rating Scale (NRS) Pain Scores Recorded in the Morning Using a Mixed Model for Repeated Measures | Baseline (day -7 to day -1), Week 4 (day 22 to day 28) | Full analysis set. Participants from one site are excluded due to lack of data integrity. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 4 in the Weekly Average of the Worst Numeric Rating Scale (NRS) Pain Scores Recorded in the Evening Using a Mixed Model for Repeated Measures | Baseline (day -7 to day -1), Week 4 (day 22 to day 28) | Full analysis set. Participants from one site are excluded due to lack of data integrity. | units on a scale | MEAN |
| SECONDARY | Percentage of Participants With >=30% and >=50% Improvement From Baseline in the Weekly Average of the Daily Average Numeric Rating Scale (NRS) Pain Scores at Week 4 Using a Mixed Model for Repeated Measures | Baseline (day -7 to day -1), Week 4 (day 22 to day 28) | Full analysis set. Participants from one site are excluded due to lack of data integrity. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline to Weeks 2 and 4 in the Neuropathic Pain Symptom Inventory (NPSI) Total Score Using a Mixed Model for Repeated Measures (MMRM) | Baseline (day 1 prior to dosing), Weeks 2 (day 15) and Week 4 (day 29) | Full analysis set. Participants from one site are excluded due to lack of data integrity. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 4 in the Neuropathic Pain Impact on Quality of Life (NePIQoL) Total Score | Baseline (day 1), Week 4 (day 29) | Full analysis set. Participants from one site are excluded due to lack of data integrity. | units on a scale | MEAN |
| SECONDARY | Participants' Global Assess of Treatment as Measured by the Patient Global Impression of Change (PGIC) at Weeks 2 and 4 Using a Mixed Model for Repeated Measures (MMRM) | Weeks 2 (day 15) and Week 4 (day 29) | Full analysis set. Participants from one site are excluded due to lack of data integrity. Data collected beyond last dose of study medication plus 3 days are excluded from the analysis. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Weeks 2 and 4 in the Daily Sleep Interference Scale (DSIS) Using a Mixed Model for Repeated Measures | Baseline (day 1 prior to dosing), Weeks 2 (day 15) and Week 4 (day 29) | Full analysis set. Participants from one site are excluded due to lack of data integrity. Data collected beyond last dose of study medication plus 3 days are excluded from the analysis. | units on a scale | MEAN |
| SECONDARY | Kaplan-Meier Estimates for First Time to Reach 30% or More Sustained Improvement in Weekly Average of the Daily Average NRS Pain Scores | Baseline (days -7 to -1), Week 1 (days 1-7), Week 2 (day 8-14), Week 3 (days 15-21), Week 4 (days 22-29) | Full analysis set. Participants from one site are excluded due to lack of data integrity. | days | MEDIAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group99
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Week 4 in the Weekly Average of the Daily Average Numeric Rating Scale (NRS) Pain Scores Using a Mixed Model for Repeated Measures | TV-45070 4% | Baseline | 5.37 | Standard Deviation 0.992 | units on a scale |
| Change From Baseline to Week 4 in the Weekly Average of the Daily Average Numeric Rating Scale (NRS) Pain Scores Using a Mixed Model for Repeated Measures | TV-45070 8% | Baseline | 5.60 | Standard Deviation 1.236 | units on a scale |
| Change From Baseline to Week 4 in the Weekly Average of the Daily Average Numeric Rating Scale (NRS) Pain Scores Using a Mixed Model for Repeated Measures | Placebo | Baseline | 5.51 | Standard Deviation 0.963 | units on a scale |
| Change From Baseline to Week 4 in the Weekly Average of the Daily Average Numeric Rating Scale (NRS) Pain Scores Using a Mixed Model for Repeated Measures | TV-45070 4% | Change from baseline at week 4 | -1.64 | Standard Deviation 1.360 | units on a scale |
| Change From Baseline to Week 4 in the Weekly Average of the Daily Average Numeric Rating Scale (NRS) Pain Scores Using a Mixed Model for Repeated Measures | TV-45070 8% | Change from baseline at week 4 | -1.71 | Standard Deviation 1.500 | units on a scale |
| Change From Baseline to Week 4 in the Weekly Average of the Daily Average Numeric Rating Scale (NRS) Pain Scores Using a Mixed Model for Repeated Measures | Placebo | Change from baseline at week 4 | -1.90 | Standard Deviation 1.670 | units on a scale |
| Change From Baseline to Week 4 in the Weekly Average of the Average Numeric Rating Scale (NRS) Pain Scores Recorded in the Evening Using a Mixed Model for Repeated Measures | TV-45070 4% | Baseline | 5.45 | Standard Deviation 1.073 | units on a scale |
| Change From Baseline to Week 4 in the Weekly Average of the Average Numeric Rating Scale (NRS) Pain Scores Recorded in the Evening Using a Mixed Model for Repeated Measures | TV-45070 8% | Baseline | 5.66 | Standard Deviation 1.320 | units on a scale |
| Change From Baseline to Week 4 in the Weekly Average of the Average Numeric Rating Scale (NRS) Pain Scores Recorded in the Evening Using a Mixed Model for Repeated Measures | Placebo | Baseline | 5.58 | Standard Deviation 0.994 | units on a scale |
| Change From Baseline to Week 4 in the Weekly Average of the Average Numeric Rating Scale (NRS) Pain Scores Recorded in the Evening Using a Mixed Model for Repeated Measures | TV-45070 4% | Change from baseline at week 4 | -1.70 | Standard Deviation 1.412 | units on a scale |
1 to 10 of 99Source ClinicalTrials.gov
See all 99 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TV-45070 4% | 100 | |
| Overall Study | STARTED | TV-45070 8% | 100 | |
| Overall Study | STARTED | Placebo | 100 | |
| Overall Study | Safety Population | TV-45070 4% | 100 | |
| Overall Study | Safety Population | TV-45070 8% | 98 | |
| Overall Study | Safety Population | Placebo | 100 | |
| Overall Study | Full Analysis Set | TV-45070 4% | 100 | |
| Overall Study | Full Analysis Set | TV-45070 8% | 98 | |
| Overall Study | Full Analysis Set | Placebo | 100 | |
| Overall Study | COMPLETED | TV-45070 4% | 94 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events6
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 | Application site erythema | General disorders | TV-45070 4% | 2 | 100 | 3 |
| other | Application site erythema | General disorders | TV-45070 (8%) | 5 | 98 | 5 |
| other | Application site erythema | General disorders | Placebo | 1 | 100 | 2 |
| serious | Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | TV-45070 4% | 0 | 100 | 0 |
| serious | Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | TV-45070 (8%) | 1 | 98 | 1 |
| serious | Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 100 | 0 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TV-45070 4% | 0 | 100 |
| Total, all-cause mortality | TV-45070 (8%) | 0 | 98 |
| Total, all-cause mortality | Placebo | 0 | 100 |
| Total, other adverse events | TV-45070 4% | 2 | 100 |
| Total, other adverse events | TV-45070 (8%) | 5 | 98 |
| Total, other adverse events | Placebo | 1 | 100 |
| Total, serious adverse events | TV-45070 4% | 0 | 100 |
| Total, serious adverse events | TV-45070 (8%) | 1 | 98 |
| Total, serious adverse events | Placebo | 0 | 100 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37366590 | 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 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.
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