| Primary | Change in Mean Daily Pain Score From Baseline to Week 3 (With LOCF) | Subjects recorded their pain scores 4 times each day (using an 11-point Likert numerical rating scale (NRS); 0-10, where 0 = no pain and 10 = worst pain imaginable). An average (mean) daily pain score was calculated. This measurement is the 'Change in mean daily pain score from baseline between the 3rd week of XPF-002 treatment and the 3rd week of placebo treatment for each subject'. Any missing mean daily pain scores were imputed using last observation carried forward (LOCF). The reduction in pain on each treatment compared to baseline is reported as a negative number. A larger negative number, indicates a greater reduction in pain. (A positive number would indicate pain was increased compared to baseline.) | The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods. The maximum number of subjects who could contribute to this population is 57. Last Observation Carried Forward (LOCF) was used to impute any missing data. | Posted | | Least Squares Mean | 95% Confidence Interval | units on a scale | | 3 weeks | | | | ID | Title | Description |
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| OG000 | XPF-002 | XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period. | | OG001 | Placebo | Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-0.94(-1.30 to -0.58)
- OG001-0.97(-1.33 to -0.61)
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| Secondary | Change in Mean Daily Pain Score From Baseline to Week 1 | Subjects recorded their pain scores 4 times each day (using an 11-point Likert numerical rating scale (NRS); 0-10, where 0 = no pain and 10 = worst pain imaginable). An average (mean) daily pain score was calculated. This measurement is the 'Change in mean daily pain score from baseline between the 1st week of XPF-002 treatment and the 1st week of placebo treatment for each subject'. Missing data were not imputed. The reduction in pain on each treatment compared to baseline is reported as a negative number. A larger negative number, indicates a greater reduction in pain. (A positive number would indicate pain was increased compared to baseline.) | The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods. Missing data were not imputed. Only subjects who recorded sufficient pain scores in each treatment period were included in this analysis. | Posted | | Least Squares Mean | 95% Confidence Interval | units on a scale | | 1 week | | | | ID | Title | Description |
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| OG000 | XPF-002 | XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period. | | OG001 | Placebo | Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period. |
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| Secondary | Change in Mean Daily Pain Score From Baseline to Week 2 | Subjects recorded their pain scores 4 times each day (using an 11-point Likert numerical rating scale (NRS); 0-10, where 0 = no pain and 10 = worst pain imaginable). An average (mean) daily pain score was calculated. This measurement is the 'Change in mean daily pain score from baseline between the 2nd week of XPF-002 treatment and the 2nd week of placebo treatment for each subject'. Missing data were not imputed. The reduction in pain on each treatment compared to baseline is reported as a negative number. A larger negative number, indicates a greater reduction in pain. (A positive number would indicate pain was increased compared to baseline.) | The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods. Missing data were not imputed. Only subjects who recorded sufficient pain scores in each treatment period were included in this analysis. | Posted | | Least Squares Mean | 95% Confidence Interval | units on a scale | | 2 week | | | | ID | Title | Description |
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| OG000 | XPF-002 | XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period. | | OG001 | Placebo | Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period. |
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| Secondary | Change in Mean Daily Pain Score From Baseline to Week 3 | Subjects recorded their pain scores 4 times each day (using an 11-point Likert numerical rating scale (NRS); 0-10, where 0 = no pain and 10 = worst pain imaginable). An average (mean) daily pain score was calculated. This measurement is the 'Change in mean daily pain score from baseline between the 3rd week of XPF-002 treatment and the 3rd week of placebo treatment for each subject'. Missing data were not imputed. The reduction in pain on each treatment compared to baseline is reported as a negative number. A larger negative number, indicates a greater reduction in pain. (A positive number would indicate pain was increased compared to baseline.) | The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods. Missing data were not imputed. Only subjects who recorded sufficient pain scores in each treatment period were included in this analysis. | Posted | | Least Squares Mean | 95% Confidence Interval | units on a scale | | 3 Weeks | | | | ID | Title | Description |
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| OG000 | XPF-002 | XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period. | | OG001 | Placebo | Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period. |
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| Secondary | Proportion of Subjects Achieving at Least a 1 Point Improvement in Mean Daily Pain Score (Measured Using the 11-point Likert NRS) From Baseline to Week 3 on XPF-002 Compared to Placebo | Subjects recorded their pain scores 4 times each day (using an 11-point Likert numerical rating scale (NRS); 0-10, where 0 = no pain and 10 = worst pain imaginable). An average (mean) daily pain score was calculated. | The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods. Missing data were not imputed. Only subjects who recorded sufficient pain scores in each treatment period were included in this analysis. | Posted | | Number | | participants | | 3 Weeks | | | | ID | Title | Description |
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| OG000 | XPF-002 | XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period. | | OG001 | Placebo | Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period. |
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| Secondary | Proportion of Subjects Achieving 50% Improvement in Mean Daily Pain Score From Baseline to Week 3 on XPF-002 Treatment Compared to Placebo Treatment | | The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods. Missing data were not imputed. Only subjects who recorded sufficient pain scores in each treatment period were included in this analysis. | Posted | | Number | | participants | | 3 weeks | | | | ID | Title | Description |
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| OG000 | XPF-002 | XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period. | | OG001 | Placebo | Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period. |
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| Secondary | Proportion of Subjects Achieving 30% Improvement in Mean Daily Pain Score From Baseline to Week 3 on XPF-002 Treatment Compared to Placebo Treatment | | The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods. Missing data were not imputed. Only subjects who recorded sufficient pain scores in each treatment period were included in this analysis. | Posted | | Number | | participants | | 3 Weeks | | | | ID | Title | Description |
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| OG000 | XPF-002 | XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period. | | OG001 | Placebo | Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period. |
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| Secondary | Proportion of Subjects Using Rescue Analgesic Medications During XPF-002 Treatment Compared to Placebo Treatment | | | Posted | | Number | | participants | | 3 Weeks | | | | ID | Title | Description |
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| OG000 | XPF-002 | XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period. | | OG001 | Placebo | Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period. |
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| Secondary | Change in Overall Neuropathic Pain Symptom Inventory (NPSI) From Baseline to Week 3 (With LOCF) | Subjects completed the NPSI questionaire at various timepoints during the study. An overall NPSI score (the sum of 10 quantitative responses, each scored 0-10, max score = 100) was calculated each time the NPSI questionaire was completed. This measurement is the 'Change in Neuropathic Pain Symptom Inventory (NPSI) score from baseline between the 3rd week of XPF-002 treatment and the 3rd week of placebo treatment for each subject. If the NPSI score for Week 3 was missing, the last value from within the same treatment period was used (ie last observation carried forward (LOCF)). The reduction in NPSI on each treatment compared to baseline is reported as a negative number. A larger negative number, indicates a greater reduction in neuropathic pain symptoms. (A positive number would indicate neuropathic pain symptoms were increased compared to baseline.) | The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods. The maximum number of subjects who could contribute to this population is 57. Last Observation Carried Forward (LOCF) was used to impute any missing data. | Posted | | Mean | Standard Deviation | units on a scale | | 3 Weeks | | | | ID | Title | Description |
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| OG000 | XPF-002 | XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period. | | OG001 | Placebo |
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| Secondary | Change in Daily Sleep Interference Scale (DSIS) From Baseline to Week 3 of XPF-002 Treatment Compared to Week 3 of Placebo Treatment (With LOCF) | Subjects recorded their sleep interference scores each morning for the previous night's sleep (using an 11-point Likert numerical rating scale (NRS); 0-10, where 0 = no interference with sleep and 10 = pain completely interfered with sleep). A daily sleep interference score was calculated. This measurement is the 'Change in DSIS score from baseline between the 3rd week of XPF-002 treatment and the 3rd week of placebo treatment for each subject'. Any missing scores were imputed using last observation carried forward (LOCF). The reduction in DSIS on each treatment compared to baseline is reported as a negative number. A larger negative number, indicates a greater reduction in sleep interference due to pain. (A positive number would indicate sleep interference due to pain was increased compared to baseline.) | The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods. The maximum number of subjects who could contribute to this population is 57. Last Observation Carried Forward (LOCF) was used to impute any missing data. | Posted | | Least Squares Mean | 95% Confidence Interval | units on a scale | | 3 Weeks | | | | ID | Title | Description |
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| OG000 | XPF-002 | XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period. | | OG001 | Placebo |
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