Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| RH01778 | Other Identifier | GSK |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Rundo International Pharmaceutical Research & Development Co.,Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will investigate the efficacy of the Indomethacin patch in pain relief of ankle sprain in adult patients, compared to a placebo patch
Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which reduces pain, fever, stiffness and swelling in acute skeletal musculature injuries involving joints. However, oral Indomethacin formulations predisposes for some systemic side effects. To avoid the systemic side effects of oral Indomethacin, a topical Indomethacin formulations have been developed and approved in some countries as an Over the counter product. Present study is to investigate the efficacy of the Indomethacin patch in pain relief of ankle sprain in adult patients.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indomethacin patch | Experimental | Indomethacin patch to be applied on the sprained ankle twice a day (BID). |
|
| Placebo patch | Placebo Comparator | Placebo patch to be applied on the sprained ankle BID. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indomethacin | Drug | Topical indomethacin |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Sum of Pain Intensity Difference (SPID)1-3 Days | SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0 hrs (Day 1, pre treatment), 0.5 hrs, 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 36 hrs and 48 hrs. Positive and higher scores indicate greater reduction in pain. SPIDt = ∑PID x (time t - time t-1). Pain Intensity was assessed at baseline and at each time-point based on numerical rating scale (NRS) which is a horizontal line with a scale from 0-10, where 0 represents "No" and 10 represents the "worst possible pain" | Baseline (Day 1) to Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Relief Score (PRS) on Movement Over Time | PRS was assessed for pain on movement (walking 5 steps on flat surface) at 30, 60 minutes and 2, 4, 8 and 12 hrs after the first dose of treatment (indomethacin or placebo patch) and twice daily during the period from 12 hours to 24 hr, 36 hr, 48 hr, 60 hr, 72 hr, 84 hr, 96 hr, 108 hr, 120 hr, 132 hr and 144 hr between treatment groups. Participants were asked to choose a number on a scale of 0 to 4, where, 0- No pain relief; 1- A little or perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief; 4- Complete relief. The mean PRS scores were calculated on the basis of participant's response based on the above score. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changzhou NO.2 People's Hospital | Changzhou | Jiangsu | 213003 | China | ||
| Changzhou NO.2 People?s Hospital |
Not provided
The study was conducted across multiple sites in China.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Indomethacin Patch | 0.35% w/w Indomethacin patch was applied on the sprained ankle twice a day (BID). |
| FG001 | Placebo Patch | Placebo patch was applied on the sprained ankle BID. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Indomethacin Patch | Indomethacin patch was applied on the sprained ankle BID |
| BG001 | Placebo Patch | Placebo patch was applied on the sprained ankle BID |
| 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 | Sum of Pain Intensity Difference (SPID)1-3 Days | SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0 hrs (Day 1, pre treatment), 0.5 hrs, 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 36 hrs and 48 hrs. Positive and higher scores indicate greater reduction in pain. SPIDt = ∑PID x (time t - time t-1). Pain Intensity was assessed at baseline and at each time-point based on numerical rating scale (NRS) which is a horizontal line with a scale from 0-10, where 0 represents "No" and 10 represents the "worst possible pain" | Efficacy analysis was conducted on the Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement | Posted | Least Squares Mean | Standard Error | Score on scale | Baseline (Day 1) to Day 3 |
|
19 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Indomethacin Patch | Indomethacin patch to be applied on the sprained ankle twice a day (BID). |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gingival bleeding | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D016512 | Ankle Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Placebo patch |
|
| 30 minutes (mins) to 144 hours (hrs) post treatment |
| NRS for Pain on Movement Over Time | NRS was assessed for pain on movement (walking 5 steps on flat surface) at 30, 60 minutes and 2, 4, 8 and 12 hrs after the first dose of treatment (indomethacin or placebo patch) and twice daily during the period from 12 hours to 24 hr, 36 hr, 48 hr, 60 hr, 72 hr, 84 hr, 96 hr, 108 hr, 120 hr, 132 hr and 144 hr between treatment groups. The NRS is a horizontal line with a scale from 0-10. After application of patch (indomethacin or reference patch), patients were asked to choose a number that relates to their pain intensity on the scale of 0 to 10, where 0 represents no pain and 10 represents the worst possible pain. | 30 mins to 144 hr post treatment |
| Change From Baseline in NRS at Rest | Mean changes in pain intensity at each time point at rest twice daily (in the morning and afternoon) from treatment day 1 to day 7 between treatment groups at time points 0.5 hrs, 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs, 60 hrs, 72 hrs, 84 hrs, 96 hrs, 108 hrs, 120 hrs, 132 hrs and 144 hrs was measured using NRS. The NRS is a horizontal line with a scale from 0-10. After application of patch (indomethacin or reference patch), participants were asked to choose a number that relates to their pain intensity on the scale of 0 to 10, where 0 represents no pain and 10 represents the worst possible pain. | Baseline (Day 1) to Day 7 |
| Time to Onset of Pain Relief | Time to onset of pain relief was measured by the time to reach a pain relief score of "1" ("A little or perceptible pain relief"). | Baseline (Day 1) to Day 3 |
| Assessment of Sum of Pain Intensity Difference (SPID) on Movement | SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0 hrs (Day 1, pre treatment), 0.5 hrs, 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs, 60 hrs, 72 hrs, 84 hrs, 96 hrs, 108 hrs, 120 hrs, 132 hrs and 144 hrs. Positive and higher scores indicate greater reduction in pain. SPIDt = ∑PID x (time t - time t-1). Pain Intensity was assessed at baseline and at each time-point based on numerical rating scale (NRS) which is a horizontal line with a scale from 0-10, where 0 represents "No" and 10 represents the "worst possible pain". | Baseline (Day 1) to Day 7 |
| Sum of Pain Intensity Difference and Pain Relief (SPRID) on Movement | SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -5.8 (least pain relief) to 40.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time; 0 hr (Day 1, pre treatment), 0.5 hr, 1 hr, 2 hr, 4 hr, 8 hr, 12 hr, 24 hr, 36 hr, 48 hr, 60 hr, 72 hr, 84 hr, 96 hr, 108 hr, 120 hr, 132 hr and 144 hr, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [based on NRS which is a horizontal line with a scale from 0-10. where 0 represents "No" and 10 represents the "worst possible pain"]. NR scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief] | Baseline (Day 1) to Day 7 |
| Total Pain Relief (TOTPAR) on Movement | TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0 hrs (Day 1, baseline), 0.5 hrs, 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs, 60 hrs, 72 hrs, 84 hrs, 96 hrs, 108 hrs, 120 hrs, 132 hrs and 144 hrs. Higher score indicated greater pain relief. TOTPARt = ∑PR x (time t - time t-1). PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]. | Baseline (Day 1) to Day 7 |
| Patients' Global Assessment to Treatment | Patients global assessment in response to treatment was measured at the end of the study on a scale of 0 to 4 where: 0- Poor; 1- Fair; 2- Good; 3- Very Good; 4- Excellent | Baseline (Day 1) to Day 14 |
| Rate of Rescue Medication Use | Rescue medication use was monitored throughout a period of 14 days. | Baseline (Day 1) to Day 14 |
| Time to First Dose of Rescue Medication Use | Rescue medication use was monitored throughout a period of 14 days. | Baseline (Day 1) to Day 14 |
| Total Dose of Rescue Medication Use | Rescue medication use was monitored throughout a period of 14 days. | Baseline (Day 1) to Day 14 |
| Changzhou |
| Jiangsu |
| 213003 |
| China |
| Zhongda Hospital Southeast University | Nanjing | Jiangsu | 210009 | China |
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215006 | China |
| Ruijin Hospital Luwan Branch | Shanghai | Shanghai Municipality | 200020 | China |
| Shanghai Ruijin Hospital | Shanghai | Shanghai Municipality | 200025 | China |
| Shanghai Xuhui Centre Hospital | Shanghai | Shanghai Municipality | 200031 | China |
| Shanghai Tenth People's Hospital | Shanghai | Shanghai Municipality | 200072 | China |
| Shanghai Tenth People?s Hospital | Shanghai | Shanghai Municipality | 200072 | China |
| Shanghai Tenth Peoples Hospital | Shanghai | Shanghai Municipality | 200072 | China |
| Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 200092 | China |
| Shanghai East Hospital | Shanghai | Shanghai Municipality | 200120 | China |
| Shanghai First People's Hospital | Shanghai | Shanghai Municipality | 201620 | China |
| Shanghai First People?s Hospital | Shanghai | Shanghai Municipality | 201620 | China |
| Shanghai First Peoples Hospital | Shanghai | Shanghai Municipality | 201620 | China |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Indomethacin patch was applied on the sprained ankle BID |
| OG001 | Placebo Patch | Placebo patch was applied on the sprained ankle BID |
|
|
|
| Secondary | Pain Relief Score (PRS) on Movement Over Time | PRS was assessed for pain on movement (walking 5 steps on flat surface) at 30, 60 minutes and 2, 4, 8 and 12 hrs after the first dose of treatment (indomethacin or placebo patch) and twice daily during the period from 12 hours to 24 hr, 36 hr, 48 hr, 60 hr, 72 hr, 84 hr, 96 hr, 108 hr, 120 hr, 132 hr and 144 hr between treatment groups. Participants were asked to choose a number on a scale of 0 to 4, where, 0- No pain relief; 1- A little or perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief; 4- Complete relief. The mean PRS scores were calculated on the basis of participant's response based on the above score. | Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement. | Posted | Mean | Standard Deviation | Score on scale | 30 minutes (mins) to 144 hours (hrs) post treatment |
|
|
|
| Secondary | NRS for Pain on Movement Over Time | NRS was assessed for pain on movement (walking 5 steps on flat surface) at 30, 60 minutes and 2, 4, 8 and 12 hrs after the first dose of treatment (indomethacin or placebo patch) and twice daily during the period from 12 hours to 24 hr, 36 hr, 48 hr, 60 hr, 72 hr, 84 hr, 96 hr, 108 hr, 120 hr, 132 hr and 144 hr between treatment groups. The NRS is a horizontal line with a scale from 0-10. After application of patch (indomethacin or reference patch), patients were asked to choose a number that relates to their pain intensity on the scale of 0 to 10, where 0 represents no pain and 10 represents the worst possible pain. | Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement | Posted | Mean | Standard Deviation | Score on scale | 30 mins to 144 hr post treatment |
|
|
|
| Secondary | Change From Baseline in NRS at Rest | Mean changes in pain intensity at each time point at rest twice daily (in the morning and afternoon) from treatment day 1 to day 7 between treatment groups at time points 0.5 hrs, 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs, 60 hrs, 72 hrs, 84 hrs, 96 hrs, 108 hrs, 120 hrs, 132 hrs and 144 hrs was measured using NRS. The NRS is a horizontal line with a scale from 0-10. After application of patch (indomethacin or reference patch), participants were asked to choose a number that relates to their pain intensity on the scale of 0 to 10, where 0 represents no pain and 10 represents the worst possible pain. | Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement | Posted | Least Squares Mean | Standard Error | Score on scale | Baseline (Day 1) to Day 7 |
|
|
|
| Secondary | Time to Onset of Pain Relief | Time to onset of pain relief was measured by the time to reach a pain relief score of "1" ("A little or perceptible pain relief"). | Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement | Posted | Median | Full Range | Days | Baseline (Day 1) to Day 3 |
|
|
|
| Secondary | Assessment of Sum of Pain Intensity Difference (SPID) on Movement | SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0 hrs (Day 1, pre treatment), 0.5 hrs, 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs, 60 hrs, 72 hrs, 84 hrs, 96 hrs, 108 hrs, 120 hrs, 132 hrs and 144 hrs. Positive and higher scores indicate greater reduction in pain. SPIDt = ∑PID x (time t - time t-1). Pain Intensity was assessed at baseline and at each time-point based on numerical rating scale (NRS) which is a horizontal line with a scale from 0-10, where 0 represents "No" and 10 represents the "worst possible pain". | Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement | Posted | Least Squares Mean | Standard Error | Score on scale | Baseline (Day 1) to Day 7 |
|
|
|
| Secondary | Sum of Pain Intensity Difference and Pain Relief (SPRID) on Movement | SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -5.8 (least pain relief) to 40.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time; 0 hr (Day 1, pre treatment), 0.5 hr, 1 hr, 2 hr, 4 hr, 8 hr, 12 hr, 24 hr, 36 hr, 48 hr, 60 hr, 72 hr, 84 hr, 96 hr, 108 hr, 120 hr, 132 hr and 144 hr, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [based on NRS which is a horizontal line with a scale from 0-10. where 0 represents "No" and 10 represents the "worst possible pain"]. NR scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief] | Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement | Posted | Least Squares Mean | Standard Error | Score on scale | Baseline (Day 1) to Day 7 |
|
|
|
| Secondary | Total Pain Relief (TOTPAR) on Movement | TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0 hrs (Day 1, baseline), 0.5 hrs, 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs, 60 hrs, 72 hrs, 84 hrs, 96 hrs, 108 hrs, 120 hrs, 132 hrs and 144 hrs. Higher score indicated greater pain relief. TOTPARt = ∑PR x (time t - time t-1). PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]. | Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement | Posted | Mean | Standard Error | Score on scale | Baseline (Day 1) to Day 7 |
|
|
|
| Secondary | Patients' Global Assessment to Treatment | Patients global assessment in response to treatment was measured at the end of the study on a scale of 0 to 4 where: 0- Poor; 1- Fair; 2- Good; 3- Very Good; 4- Excellent | Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement | Posted | Least Squares Mean | Standard Error | Score on scale | Baseline (Day 1) to Day 14 |
|
|
|
| Secondary | Rate of Rescue Medication Use | Rescue medication use was monitored throughout a period of 14 days. | Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement | Posted | Number | Number of participants | Baseline (Day 1) to Day 14 |
|
|
|
| Secondary | Time to First Dose of Rescue Medication Use | Rescue medication use was monitored throughout a period of 14 days. | Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement | Posted | Median | 95% Confidence Interval | Days | Baseline (Day 1) to Day 14 |
|
|
|
| Secondary | Total Dose of Rescue Medication Use | Rescue medication use was monitored throughout a period of 14 days. | Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement | Posted | Median | Full Range | Dose | Baseline (Day 1) to Day 14 |
|
|
|
| 0 |
| 135 |
| 10 |
| 135 |
| EG001 | Placebo Patch | Placebo patch to be applied on the sprained ankle BID. | 0 | 135 | 5 | 135 |
| Application site pruritis | General disorders | Systematic Assessment |
|
| Inflammation | General disorders | Systematic Assessment |
|
| Upper respiratory tract infections | Infections and infestations | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Erythma | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Vascular rupture | Vascular 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.
| 2 hr |
|
| 4 hr |
|
| 8 hr |
|
| 12 hr |
|
| 24 hr |
|
| 36 hr |
|
| 48 hr |
|
| 60 hr |
|
| 72 hr |
|
| 84 hr |
|
| 96 hr |
|
| 108 hr |
|
| 120 hr |
|
| 132 hr |
|
| 144 hr |
|
| 2 hr |
|
| 4 hr |
|
| 8 hr |
|
| 12 hr |
|
| 24 hr |
|
| 36 hr |
|
| 48 hr |
|
| 60 hr |
|
| 72 hr |
|
| 84 hr |
|
| 96 hr |
|
| 108 hr |
|
| 120 hr |
|
| 132 hr |
|
| 144 hr |
|
| SPRID (1-7 days) |
|
| TOPTAR (1-7 days) |
|