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| ID | Type | Description | Link |
|---|---|---|---|
| RH01805 | Other Identifier | GSK |
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This Phase III pivotal efficacy study will assess efficacy and onset of pain relief of MFC51123 gel vs. placebo and MFC51123 gel vs. 1% diclofenac gel and 3% menthol gel in participants with an ankle sprain to support topical MFC51123 gel registration.
This is a multi-center, randomized, double-blind, repeat-dose, placebo-controlled, parallel-group trial in participants with ankle sprain. Eligible participants will be randomly assigned to one of four treatment groups (1% diclofenac plus 3% menthol gel, 1% diclofenac plus 0.09% menthol gel, 3% menthol gel or placebo gel with 0.09% menthol). Treatment will be self-administered by participants four times daily on an out-patient basis. Participants will rate pain intensity score (NRS) at rest and on movement, pain relief score (PRS) and cooling and soothing sensations. After leaving the clinic, participants will continue to complete scheduled pain intensity and pain relief assessments and answer questions about cooling sensation by answering questions in a paper diary card. The investigator (or designee) will measure the ankle swelling via the 'figure-of-eight' method on treatment Days 1 (at Baseline), 3, 7 and 10.
Participants will continue treatment until they are pain free or for up to 10 days, whichever occurs first. At the end of the treatment, participants will be assessed for function of the injured joint by the investigator. In addition, the participants will evaluate treatment satisfaction, sensory features of the gel and provide a global assessment of the treatment by using a questionnaire.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1% diclofenac sodium plus 3% menthol | Experimental | 1% diclofenac sodium plus 3% menthol gel supplied in 30 gram (g) tubes sufficient for each subject to apply 4g of gel to the injured ankle region four times daily for up to 10 days. |
|
| 1% diclofenac sodium plus 0.09% menthol | Experimental | 1% diclofenac sodium plus 0.09% menthol gel supplied in 30g tubes sufficient for each subject to apply 4g of gel to the injured ankle region four times daily for up to 10 days. |
|
| 3% menthol | Experimental | 3% menthol gel supplied in 30g tubes sufficient for each subject to apply 4g of gel to the injured ankle region four times daily for up to 10 days. |
|
| Placebo with 0.09% menthol gel | Placebo Comparator | Placebo with 0.09% menthol gel supplied in 30g tubes sufficient for each subject to apply 4g of gel to the injured ankle region four times daily for up to 10 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1% diclofenac sodium plus 3% menthol | Drug | To be applied four times daily for 10 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Day 1 to Day 3 (AUC1-3 Days) of Pain Intensity(PI) on Movement for Diclofenac/Methanol Gel and Placebo Gel | AUC of PI on movement was measured by a numerical rating scale (NRS) during the 48 hour time interval from Day 1 to 3. AUC1-3 day was calculated based on trapezoidal method. Pain intensity was measured in NRS scale from 0 (no pain) to 10 (extreme pain). Participants assessed the severity of ankle pain using the NRS scale at baseline (prior to treatment) and at 10, 30 minutes and 1, 4, 6, 12, 18 and 24 hours after the first dose of treatment and twice daily after dosing. | up to 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| AUC1-3 Days of PI on Movement for Diclofenac Sodium + Methanol, Diclofenac, Methanol and Placebo | AUC of PI on movement was measured by a numerical rating scale (NRS) during the 48 hour time interval from Day 1 to 3. AUC1-3 day was calculated based on trapezoidal method. Pain intensity was measured in NRS scale from 0 (no pain) to 10 (extreme pain). Participants assessed the severity of ankle pain using the NRS scale at baseline (prior to treatment) and at 10, 30 minutes and 1, 4, 6, 12, 18 and 24 hours after the first dose of treatment and twice daily after dosing. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PAREXEL International - Sites in Germany | Berlin | D-14050 | Germany | |||
| PAREXEL International, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28345425 | Derived | Lai PM, Collaku A, Reed K. Efficacy and safety of topical diclofenac/menthol gel for ankle sprain: A randomized, double-blind, placebo- and active-controlled trial. J Int Med Res. 2017 Apr;45(2):647-661. doi: 10.1177/0300060517700322. Epub 2017 Mar 27. |
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A total of 388 participants were screened, out of which 385 were randomized, 3 did not meet the study criteria. Of the 385 participants randomized, 360 participants completed the study, 25 did not complete the study.
Participants were recruited at 16 centers in Germany.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1% Diclofenac Sodium+3% Menthol | 1% diclofenac sodium with 3% menthol gel was supplied in 30 gram (g) tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days. |
| FG001 | 1% Diclofenac Sodium | 1% diclofenac sodium with 0.09% methanol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days. |
| FG002 | 3% Menthol | 3% menthol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days. |
| FG003 | Placebo | Placebo with 0.09% methanol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Only 381 participants were included in safety population.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 1% Diclofenac Sodium+3% Menthol | 1% diclofenac sodium with 3% menthol gel was supplied in 30 gram (g) tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days. |
| BG001 | 1% Diclofenac Sodium |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Curve From Day 1 to Day 3 (AUC1-3 Days) of Pain Intensity(PI) on Movement for Diclofenac/Methanol Gel and Placebo Gel | AUC of PI on movement was measured by a numerical rating scale (NRS) during the 48 hour time interval from Day 1 to 3. AUC1-3 day was calculated based on trapezoidal method. Pain intensity was measured in NRS scale from 0 (no pain) to 10 (extreme pain). Participants assessed the severity of ankle pain using the NRS scale at baseline (prior to treatment) and at 10, 30 minutes and 1, 4, 6, 12, 18 and 24 hours after the first dose of treatment and twice daily after dosing. | Intent-to-Treat (ITT) population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population. | Posted | Mean | Standard Deviation | NRS Score (0 - 10 scale) * hrs | up to 72 hours |
|
Up to 3 weeks of administration of investigational product
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1% Diclofenac Sodium Plus 3% Menthol | 1% diclofenac sodium plus 3% menthol gel supplied in 30 gram (g) tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| APPLICATION SITE DRYNESS | General disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D004008 | Diclofenac |
| D008610 | Menthol |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| 1% diclofenac sodium plus 0.09% menthol | Drug | To be applied four times daily for 10 days. |
|
| 3% menthol | Drug | To be applied four times daily for 10 days. |
|
| Placebo with 0.09% menthol gel | Drug | To be applied four times daily for 10 days. |
|
| up to 72 hours |
| Pain Intensity Difference (PID) on Movement | PID on movement, calculated as PI at a given time 't' (after walking 5 steps on a flat surface) subtracted by the PI at baseline. Participants assessed the severity of ankle pain (PI) using the NRS scale from 0 (no pain) to 10 (extreme pain). PI was measured at baseline (prior to treatment) and at 10, 30 minutes (min.) and 1, 4, 6, 12, 18 and 24 hours after the first dose of treatment and twice daily after dosing. | Baseline to 10 days |
| PID at Rest | PID at rest was calculated as PI at a given time point't' (at rest) subtracted by the PI at baseline. Participants assessed the severity of ankle pain (PI) using the NRS scale from 0 (no pain) to 10 (extreme pain). PI was measured at baseline (prior to treatment) and at 10, 30 minutes and 1, 4, 6, 12, 18 and 24 hours after the first dose of treatment and twice daily after dosing. | Baseline to 10 days |
| Pain Relief Score (PRS) | Pain relief was measured at each time point using a 5-point Pain Relief Scale ranging from 0-4 while at rest (Where: 0- No pain relief; 1- A little or perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief; 4- Complete relief). Participants assessed the degree of ankle pain relief using the PRS scores at 10, 30 minutes and 1, 4, 6, 12, 18 and 24 hours after the first dose of treatment and twice daily after the first day of treatment. | Day 1 to Day 7 |
| Sum of Pain Intensity Difference (SPID) | SPID was calculated as the time weighted sum of pain intensity differences (PID) from 0 to 7 Days. PID was calculated as PI at a given time point 't' subtracted by the PI at baseline. PI was measured on NRS scale from 0 (no pain) to 10 (extreme pain). The possible range of SPID for 0-6 hours was from -60 to 60, for 0-12 hours was from -120 to 120, for 0-1 day was from -240 to 240, for 0-3 days was from -720 to 720, for 0-7 days was from -1680 to 1680. A higher value of SPID indicates greater pain relief. | Baseline to Day 7 |
| Time of Onset of Pain Relief (TOPR) | TOPR was measured by time when participants reported PRS ≥ 1, i.e. a "little" or "perceptible" pain relief'. | Baseline to 10 days (end of study) |
| Time of Onset of Meaningful Pain Relief (TOMR) | TOMR was measured by time when participants reported PRS ≥ 2, i.e. "some" or "meaningful" pain relief | up to 10 days (end of study) |
| Time of Onset of Cooling Sensation (TOCS) | Time of onset of cooling sensation measured by time when subjects reported to have a 'cooling effect as an enhancement of pain relief'. To assess this endpoint, participants were asked at 10, 30 minutes and at 1, 4, 6 hours post first dose "Do you feel a cooling sensation at the injured ankle from the study gel? | up to 6 hours |
| Total Pain Relief (TOTPAR) | TOTPAR was calculated as sum of the products of PRS with time interval from one time point to the other. PRS was measured at each time point on a scale: 0= No pain relief, 1= A little or perceptible pain relief, 2= Meaningful pain relief, 3= A lot of relief, 4= Complete relief. The possible range of TOTPAR for 0-6 hours was from 0 to 24, for 0-12 hours was from 0 to 48, for 0-24 hours was from 0 to 96, for 0-72 hours was from 0 to 288, for 24-72 hours was from 0 to 192 and for 0-168 hours was from 0 to 672. | Baseline to 168 hours |
| Skin Temperature | Skin temperature was measured by thermal imaging. | At 10, 30, 60 minutes, 4 and 6 hours |
| Ankle Swelling | Ankle swelling measured by "figure of eight" method of injured ankle. | Day 1 (baseline), 3, and 7 |
| Time to Complete Recovery | Time to complete recovery measured as the day with complete relief of ankle pain (Participant-rated NRS scores were 0 for pain intensity at rest and pain) and swelling (Participants did not have any apparent swelling nor experience any pain or limitation of movement of the injured ankle as determined by the Principal Investigator or designee during the course of an ankle exam). | up to 240 hours |
| Patient's Global Assessment in Response to Treatment (PGART) | PGART was measured at the end of study in a scale from 0-4 (Where: 0- Poor; 1- Fair; 2- Good; 3- Very Good; 4- Excellent) | up to Day 10 |
| Berlin |
| D-14050 |
| Germany |
| pro scientia med im MARE Klinikum | Kiel | 24119 | Germany |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal of Consent |
|
| No swelling no pain |
|
| Poor Efficacy |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
1% diclofenac sodium with 0.09% methanol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days. |
| BG002 | 3% Menthol | 3% menthol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days. |
| BG003 | Placebo | Placebo with 0.09% methanol gel was supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
1% diclofenac sodium+3% menthol gel was supplied in 30 gram (g) tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days. |
| OG001 | Placebo | Placebo gel was supplied in 30g tubes for each participant to apply 4g of gel topically to the injured ankle region four times daily for up to 10 days. |
|
|
|
| Secondary | AUC1-3 Days of PI on Movement for Diclofenac Sodium + Methanol, Diclofenac, Methanol and Placebo | AUC of PI on movement was measured by a numerical rating scale (NRS) during the 48 hour time interval from Day 1 to 3. AUC1-3 day was calculated based on trapezoidal method. Pain intensity was measured in NRS scale from 0 (no pain) to 10 (extreme pain). Participants assessed the severity of ankle pain using the NRS scale at baseline (prior to treatment) and at 10, 30 minutes and 1, 4, 6, 12, 18 and 24 hours after the first dose of treatment and twice daily after dosing. | ITT population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population. | Posted | Mean | Standard Deviation | NRS Score (0 - 10 scale) * hrs | up to 72 hours |
|
|
|
|
| Secondary | Pain Intensity Difference (PID) on Movement | PID on movement, calculated as PI at a given time 't' (after walking 5 steps on a flat surface) subtracted by the PI at baseline. Participants assessed the severity of ankle pain (PI) using the NRS scale from 0 (no pain) to 10 (extreme pain). PI was measured at baseline (prior to treatment) and at 10, 30 minutes (min.) and 1, 4, 6, 12, 18 and 24 hours after the first dose of treatment and twice daily after dosing. | ITT population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population. n is number of participants analyzed for respective time point for this outcome. | Posted | Mean | Standard Deviation | score on scale | Baseline to 10 days |
|
|
|
| Secondary | PID at Rest | PID at rest was calculated as PI at a given time point't' (at rest) subtracted by the PI at baseline. Participants assessed the severity of ankle pain (PI) using the NRS scale from 0 (no pain) to 10 (extreme pain). PI was measured at baseline (prior to treatment) and at 10, 30 minutes and 1, 4, 6, 12, 18 and 24 hours after the first dose of treatment and twice daily after dosing. | ITT population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population. n is number of participants analyzed for respective time point for this outcome. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 10 days |
|
|
|
| Secondary | Pain Relief Score (PRS) | Pain relief was measured at each time point using a 5-point Pain Relief Scale ranging from 0-4 while at rest (Where: 0- No pain relief; 1- A little or perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief; 4- Complete relief). Participants assessed the degree of ankle pain relief using the PRS scores at 10, 30 minutes and 1, 4, 6, 12, 18 and 24 hours after the first dose of treatment and twice daily after the first day of treatment. | ITT population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population. n is number of participants analyzed for respective time point for this outcome. | Posted | Mean | Standard Deviation | score on a scale | Day 1 to Day 7 |
|
|
|
| Secondary | Sum of Pain Intensity Difference (SPID) | SPID was calculated as the time weighted sum of pain intensity differences (PID) from 0 to 7 Days. PID was calculated as PI at a given time point 't' subtracted by the PI at baseline. PI was measured on NRS scale from 0 (no pain) to 10 (extreme pain). The possible range of SPID for 0-6 hours was from -60 to 60, for 0-12 hours was from -120 to 120, for 0-1 day was from -240 to 240, for 0-3 days was from -720 to 720, for 0-7 days was from -1680 to 1680. A higher value of SPID indicates greater pain relief. | ITT population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Day 7 |
|
|
|
| Secondary | Time of Onset of Pain Relief (TOPR) | TOPR was measured by time when participants reported PRS ≥ 1, i.e. a "little" or "perceptible" pain relief'. | ITT population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population. | Posted | Median | Full Range | Hours | Baseline to 10 days (end of study) |
|
|
|
|
| Secondary | Time of Onset of Meaningful Pain Relief (TOMR) | TOMR was measured by time when participants reported PRS ≥ 2, i.e. "some" or "meaningful" pain relief | ITT population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population. | Posted | Median | Full Range | Hours | up to 10 days (end of study) |
|
|
|
|
| Secondary | Time of Onset of Cooling Sensation (TOCS) | Time of onset of cooling sensation measured by time when subjects reported to have a 'cooling effect as an enhancement of pain relief'. To assess this endpoint, participants were asked at 10, 30 minutes and at 1, 4, 6 hours post first dose "Do you feel a cooling sensation at the injured ankle from the study gel? | ITT population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population. | Posted | Median | Full Range | Hours | up to 6 hours |
|
|
|
|
| Secondary | Total Pain Relief (TOTPAR) | TOTPAR was calculated as sum of the products of PRS with time interval from one time point to the other. PRS was measured at each time point on a scale: 0= No pain relief, 1= A little or perceptible pain relief, 2= Meaningful pain relief, 3= A lot of relief, 4= Complete relief. The possible range of TOTPAR for 0-6 hours was from 0 to 24, for 0-12 hours was from 0 to 48, for 0-24 hours was from 0 to 96, for 0-72 hours was from 0 to 288, for 24-72 hours was from 0 to 192 and for 0-168 hours was from 0 to 672. | ITT population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population. | Posted | Mean | Standard Deviation | PRS Score (0 - 4 scale) | Baseline to 168 hours |
|
|
|
| Secondary | Skin Temperature | Skin temperature was measured by thermal imaging. | ITT population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population. | Posted | Mean | Standard Deviation | degree celsius (°C) | At 10, 30, 60 minutes, 4 and 6 hours |
|
|
|
| Secondary | Ankle Swelling | Ankle swelling measured by "figure of eight" method of injured ankle. | ITT population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population. | Posted | Mean | Standard Deviation | Millimeters | Day 1 (baseline), 3, and 7 |
|
|
|
| Secondary | Time to Complete Recovery | Time to complete recovery measured as the day with complete relief of ankle pain (Participant-rated NRS scores were 0 for pain intensity at rest and pain) and swelling (Participants did not have any apparent swelling nor experience any pain or limitation of movement of the injured ankle as determined by the Principal Investigator or designee during the course of an ankle exam). | ITT population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population. | Posted | Median | Full Range | Hours | up to 240 hours |
|
|
|
|
| Secondary | Patient's Global Assessment in Response to Treatment (PGART) | PGART was measured at the end of study in a scale from 0-4 (Where: 0- Poor; 1- Fair; 2- Good; 3- Very Good; 4- Excellent) | ITT population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population. | Posted | Number | Participants | up to Day 10 |
|
|
|
| 0 |
| 117 |
| 43 |
| 117 |
| EG001 | 1% Diclofenac Sodium Plus 0.09% Menthol | 1% diclofenac sodium plus 0.09% menthol gel supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days. | 0 | 112 | 26 | 112 |
| EG002 | 3% Menthol | 3% menthol gel supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days. | 0 | 77 | 22 | 77 |
| EG003 | Placebo With 0.09% Menthol Gel | Placebo with 0.09% menthol gel supplied in 30g tubes sufficient for each participant to apply 4g of gel to the injured ankle region four times daily for up to 10 days. | 0 | 75 | 17 | 75 |
| APPLICATION SITE PAIN | General disorders | Systematic Assessment |
|
| APPLICATION SITE PRURITUS | General disorders | Systematic Assessment |
|
| APPLICATION SITE ERYTHEMA | General disorders | Systematic Assessment |
|
| APPLICATION SITE ECZEMA | General disorders | Systematic Assessment |
|
| APPLICATION SITE DISCOLOURATION | General disorders | Systematic Assessment |
|
| APPLICATION SITE RASH | General disorders | Systematic Assessment |
|
| APPLICATION SITE REACTION | General disorders | Systematic Assessment |
|
| APPLICATION SITE VESICLES | General disorders | Systematic Assessment |
|
| ASTHENIA | General disorders | Systematic Assessment |
|
| NECROSIS | General disorders | Systematic Assessment |
|
| APPLICATION SITE BURN | General disorders | Systematic Assessment |
|
| APPLICATION SITE HYPERSENSITIVITY | General disorders | Systematic Assessment |
|
| APPLICATION SITE SWELLING | General disorders | Systematic Assessment |
|
| DRY SKIN | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| PRURITUS | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| ERYTHEMA | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| BLISTER | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| DERMATITIS | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| DERMATITIS CONTACT | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| SKIN EXFOLIATION | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| SKIN WRINKLING | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| ECZEMA | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| RASH VESICULAR | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| SKIN REACTION | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | Systematic Assessment |
|
| BURNING SENSATION | Nervous system disorders | Systematic Assessment |
|
| HYPOAESTHESIA | Nervous system disorders | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | Systematic Assessment |
|
| PYODERMA | Infections and infestations | Systematic Assessment |
|
| SINUSITIS | Infections and infestations | Systematic Assessment |
|
| VERTIGO | Ear and labyrinth disorders | Systematic Assessment |
|
| HYPERSENSITIVITY | Immune system disorders | Systematic Assessment |
|
| SKIN ABRASION | Injury, poisoning and procedural complications | Systematic Assessment |
|
| ARTHROPOD STING | Injury, poisoning and procedural complications | Systematic Assessment |
|
| MUSCLE INJURY | Injury, poisoning and procedural complications | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| BONE SWELLING | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| EXOSTOSIS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D003511 |
| Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D000081005 | Cyclohexane Monoterpenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D039821 | Monoterpenes |
| D013729 | Terpenes |
| D008055 | Lipids |
| ANCOVA | Least squares (LS) means from mixed model analysis of covariance with treatment, site as fixed effects, pain intensity at baseline as a covariates. | 0.8164 | P-value from multiple comparisons using t-test in Proc Mixed | LS mean difference | 2.61 | 2-Sided | 95 | -19.46 | 24.67 | Difference of LS mean of first named treatment minus second named treatment. Lower values of LS mean favours a better response because of lower pain intensity over time. 95% Confidence intervals of difference between LS means. | Superiority or Other |
| ANCOVA | Least squares (LS) means from mixed model analysis of covariance with treatment, site as fixed effects, pain intensity at baseline as a covariates. | 0.9279 | P-value from multiple comparisons using t-test in Proc Mixed | LS mean difference | 1.03 | 2-Sided | 95 | -21.27 | 23.33 | Difference of LS mean of first named treatment minus second named treatment. Lower values of LS mean favours a better response because of lower pain intensity over time. 95% Confidence intervals of difference between LS means. | Superiority or Other |
| ANCOVA | Least squares (LS) means from mixed model analysis of covariance with treatment, site as fixed effects, pain intensity at baseline as a covariates. | 0.3442 | P-value from multiple comparisons using t-test in Proc Mixed. | LS mean difference | -10.81 | 2-Sided | 95 | -33.26 | 11.64 | Difference of LS mean of first named treatment minus second named treatment. Lower values of LS mean favours a better response because of lower pain intensity over time. 95% Confidence intervals of difference between LS means. | Superiority or Other |
| PID at 10 min. (n=117, 112, 77, 75) |
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| PID at 30 min. (n=117, 112, 77, 75) |
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| PID at 1 hour (n=117, 112, 77, 75) |
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| PID at 4 hour (n=117, 112, 77, 75) |
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| PID at 6 hour (n=117, 112, 77, 75) |
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| PID at 12 hour (n= 117, 112, 77, 75) |
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| PID at 18 hour (n=117, 112, 77, 75) |
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| PID at 24 hour (n=117, 112, 77, 75) |
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| PID at 36 hour (n=117, 112, 77, 75) |
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| PID at 48 hour (n=117, 112, 77, 75) |
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| PID at 60 hour (n=117, 112, 77, 75) |
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| PID at 72 hour (n=117, 112, 77, 75) |
|
| PID at 84 hour (n=113, 107, 75, 75) |
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| PID at 96 hour (n=112, 107, 75, 74) |
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| PID at 108 hour (n=112, 107, 75, 74) |
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| PID at 120 hour (n=111, 107, 74, 74) |
|
| PID at 132 hour (n=110, 107, 74, 74) |
|
| PID at 144 hour (n=110, 107, 74, 74) |
|
| PID at 156 hour (n=109, 107, 74, 74) |
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| PID at 168 hour (n=105, 104, 73, 74) |
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| PID at 180 hour (n=105, 104, 73, 72) |
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| PID at 192 hour (n=101, 102, 71, 72) |
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| PID at 204 hour (n=101, 100, 71, 72) |
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| PID at 216 hour (n=95, 100, 69, 72) |
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| PID at 228 hour (n=95, 100, 69, 72) |
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| PID at 240 hour (n=32, 43, 22, 42) |
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| PID at 10 min. (n=117, 112, 77, 75) |
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| PID at 30 min. (n=117, 112, 77, 75) |
|
| PID at 1 hour (n=117, 112, 77, 75) |
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| PID at 4 hour (n=117, 112, 77, 75) |
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| PID at 6 hour (n= 117, 112, 77, 75) |
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| PID at 12 hour (n= 117, 112, 77, 75) |
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| PID at 18 hour (n= 117, 112, 77, 75) |
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| PID at 24 hour (n= 117, 112, 77, 75) |
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| PID at 36 hour (n= 117, 112, 77, 75) |
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| PID at 48 hour (n=117, 112, 77, 75) |
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| PID at 60 hour (n= 117, 112, 77, 75) |
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| PID at 72 hour (n= 117, 112, 77, 75) |
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| PID at 84 hour (n= 113, 107, 75, 75) |
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| PID at 96 hour (n= 112, 107, 75, 74) |
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| PID at 108 hour (n=112, 107, 75, 74) |
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| PID at 120 hour (n= 111, 107, 74, 74) |
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| PID at 132 hour (n= 110, 107, 74, 74) |
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| PID at 144 hour (n= 110, 107, 74, 74) |
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| PID at 156 hour (n= 109, 107, 74, 74) |
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| PID at 168 hour (n= 105, 104, 73, 74) |
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| PID at 180 hour (n= 105, 104, 73, 72) |
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| PID at 192 hour (n= 101, 102, 71, 72) |
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| PID at 204 hour (n= 101, 100, 71, 72) |
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| PID at 216 hour (n= 95, 100, 69, 72) |
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| PID at 228 hour (n= 95, 100, 69, 72) |
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| PID at 240 hour (n= 32, 43, 22, 42) |
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| At 30 min. (n=117, 111, 77, 75) |
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| At 1 hour (n=116, 112, 77, 75) |
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| At 4 hour (n= 115, 110, 74, 71) |
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| At 6 hour (n= 109, 105, 70, 69) |
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| At 12 hour (n= 77, 89, 53, 58) |
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| At 18 hour (n= 76, 78, 53, 57) |
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| At 24 hour (n= 111, 105, 72, 72) |
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| At 36 hour (n= 116, 112, 77, 74) |
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| At 48 hour (n= 116, 112, 77, 75) |
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| At 60 hour (n=115, 111, 77, 75) |
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| At 72 hour (n= 114, 109, 75, 74) |
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| At 84 hour (n= 113, 106, 75, 75) |
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| At 96 hour (n= 112, 106, 75, 74) |
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| At 108 hour (n= 111, 105, 75, 74) |
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| At 120 hour (n= 111, 107, 74, 72) |
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| At 132 hour (n= 110, 107, 73, 74) |
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| At 144 hour (n= 110, 107, 74, 73) |
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| At 156 hour (n= 109, 106, 74, 74) |
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| At 168 hour (n= 105, 103, 73, 73) |
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| At 0-12 hours |
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| At 0-1 days |
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| At 1 to 3 days |
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| At 0 to 7 days |
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| chi-square test of survival analysis |
| 0.4639 |
P-value from chi-square test of survival analysis. |
| Cox proportional hazard ratio |
| 0.90 |
| 2-Sided |
| 95 |
| 0.67 |
| 1.20 |
Cox proportional hazard ratio of survival time, i.e. time to reach perceptible pain relief. The 95% confidence intervals of cox proportional hazard ratio. |
| Superiority or Other |
| chi-square test of survival analysis | 0.5118 | P-value from chi-square test of survival analysis. | Cox proportional hazard ratio | 1.09 | 2-Sided | 95 | 0.84 | 1.43 | Cox proportional hazard ratio of survival time, i.e. time to reach perceptible pain relief. The 95% confidence intervals of cox proportional hazard ratio. | Superiority or Other |
| chi-square test of survival analysis |
| 0.2389 |
P-value from chi-square test of survival analysis. |
| Cox proportional hazard ratio |
| 1.23 |
| 2-Sided |
| 95 |
| 0.87 |
| 1.73 |
Cox proportional hazard ratio of survival time, i.e. time to reach perceptible pain relief. The 95% confidence intervals of cox proportional hazard ratio. |
| Superiority or Other |
| chi-square test of survival analysis | 0.9817 | P-value from chi-square test of survival analysis. | Cox proportional hazard ratio | 1.00 | 2-Sided | 95 | 0.74 | 1.37 | Cox proportional hazard ratio of survival time, i.e. time to reach perceptible pain relief. The 95% confidence intervals of cox proportional hazard ratio. | Superiority or Other |
| chi-square test of survival analysis |
| 0.9565 |
P-value from chi-square test of survival analysis. |
| Cox proportional hazard ratio |
| 1.01 |
| 2-Sided |
| 95 |
| 0.75 |
| 1.35 |
Cox proportional hazard ratio of survival time, i.e. time to cooling sensation. The 95% confidence intervals of cox proportional hazard ratio. |
| Superiority or Other |
| chi-square test of survival analysis | 0.6216 | P-value from chi-square test of survival analysis. | Cox proportional hazard ratio | 1.07 | 2-Sided | 95 | 0.82 | 1.40 | Cox proportional hazard ratio of survival time, i.e. time to cooling sensation. The 95% confidence intervals of cox proportional hazard ratio. | Superiority or Other |
| 0-12 hours |
|
| 0- 24 hours |
|
| 0-72 hours |
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| 24-72 hours |
|
| 0-168 hours |
|
| At 30 min. |
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| At 60 min. |
|
| At 240 min. |
|
| At 360 min. |
|
| At Day 3 |
|
| At Day 7 |
|
| chi-square test of survival analysis |
| 0.4507 |
P-value from chi-square test of survival analysis. |
| Cox proportional hazard ratio |
| 1.31 |
| 2-Sided |
| 95 |
| 0.65 |
| 2.65 |
Cox proportional hazard ratio of survival time, i.e. time to complete pain relief. The 95% confidence intervals of cox proportional hazard ratio. |
| Superiority or Other |
| chi-square test of survival analysis | 0.3150 | P-value from chi-square test of survival analysis. | Cox proportional hazard ratio | 1.38 | 2-Sided | 95 | 0.73 | 2.61 | Cox proportional hazard ratio of survival time, i.e. time to complete pain relief. The 95% confidence intervals of cox proportional hazard ratio. | Superiority or Other |
| Fair=1 |
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| Good=2 |
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| Very Good=3 |
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| Excellent=4 |
|