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| Name | Class |
|---|---|
| ClinSearch | OTHER |
| CRM Biometrics GmbH | INDUSTRY |
| Clinigen, Inc. | INDUSTRY |
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Objective of this study is:
to determine efficacy and safety of a Esflurbiprofen Hydrogel Patch compared to placebo in patients with acute strains, sprains or bruises of the extremities following blunt trauma, e.g. sports injuries.
to demonstrate that the Esflurbiprofen Hydrogel Patch is superior to placebo, and that the patch has acceptable local tolerability.
Study Design Randomized (1:1) (stratified by center and 2 subgroups), controlled, double-blind, multi-centric study in parallel groups. Patient Population/Sample size/Study Sites
The clinical trial population will consist of male or female patients, 18 - 60 years suffering from acute; strains, sprains or bruises of the extremities following blunt trauma, and meeting all clinical trial entry criteria.
200 patients will be enrolled (assumes a drop-out-rate of ≤10%).
The study will be performed in Germany in 3 sites
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Arm | Experimental | Esflurbiprofen Hydrogel Patch containing 165 mg Esflurbiprofen |
|
| Control Drug | Placebo Comparator | Placebo patch that does not contain the active ingredient but is otherwise indistinguishable from the investigational drug Esflurbiprofen Hydrogel Patch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esflurbiprofen Hydrogel Patch | Drug | Esflurbiprofen is a cyclooxygenase (COX) inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Pain-on-movement (POM) Compared to Baseline | Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain" | Change from baseline to Visit 5 (72 hours after initiating treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain-on-movement (POM) on VAS | Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain" | Baseline and 12, 24, 48, 72, 96, 168 hours after initiating treatment |
| Area-under-the-curve for POM on VAS |
| Measure | Description | Time Frame |
|---|---|---|
| Adhesive Power of the Patch | Adhesive power of the patch measured by a 5 point numerical scale (0= ≥ 90 % adhered, 1= ≥ 75 % to < 90 % adhered, 2= ≥ 50 % to < 75 % adhered, 3= > 0 % to <50 % adhered, 4=completely detached) at every visit except V1. | 12h for day 1, 24h for day 1-5 and 7 after application of each patch |
Inclusion criteria
Exclusion criteria
significant concomitant injury in association with the index acute sports-related soft- tissue injury/contusion; e.g. fracture, nerve injury, ligament disruption, tear of muscle or cartilage, or open wound
excessively hairy skin at application site, cutting the hair in the injured site prior to patch application will qualify for inclusion
current skin disorder or shaving hair at application site
history of excessive sweating/hyperhidrosis inclusive of application site
intake of NSAIDs or analgesics within 36 hours, opioids within 7 days, or corticosteroids within 60 days of inclusion in the study
intake of long-acting NSAIDs or application of topical medication since the injury (RICE allowed)
participation in a clinical study within 30 days before inclusion in the study or concomitantly
drug or alcohol abuse in the opinion of the investigator
Pregnant and lactating women
Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) who are not using an acceptable method of contraception defined as:
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| Name | Affiliation | Role |
|---|---|---|
| Hiroshi Aoki | Teikoku Seiyaku Co., Ltd. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deutsche Sporthochschule Köln Institut für Kreislaufforschung und Sportmedizin | Cologne | North Rhine-Westphalia | 50933 | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Arm | Esflurbiprofen Hydrogel Patch containing 165 mg Esflurbiprofen |
| FG001 | Control Drug | Placebo patch that does not contain the active ingredient but is otherwise indistinguishable from the investigational drug Esflurbiprofen Hydrogel Patch |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Arm | Esflurbiprofen Hydrogel Patch containing 165 mg Esflurbiprofen |
| BG001 | Control Drug | Placebo patch that does not contain the active ingredient but is otherwise indistinguishable from the investigational drug Esflurbiprofen Hydrogel Patch |
| 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 | Change of Pain-on-movement (POM) Compared to Baseline | Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain" | The Full Analysis Set (all randomized patients who received at least one dose of study drug). | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to Visit 5 (72 hours after initiating treatment) |
|
From Baseline assessment for up to 7 days (±1 days)
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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 | Active Arm | Esflurbiprofen Hydrogel Patch containing 165 mg Esflurbiprofen | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Forearm fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hirofumi Fujiwara | Teikoku Seiyaku Co.,Ltd. | +81362649123 | hirofumi-fujiwara@teiyaku.co.jp |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 8, 2021 | Nov 1, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 9, 2021 | Nov 1, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D017695 | Soft Tissue Injuries |
| D003288 | Contusions |
| D013180 | Sprains and Strains |
| D014949 | Wounds, Nonpenetrating |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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Randomized, controlled, double-blind, multi-center
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Packages of Investigative Medicinal product will be non-distinguishable to patients, study site staff and monitors.
Randomization data are kept strictly confidential, accessible only to authorized persons, until the time of unblinding the identity of the treatments will be concealed by the use of study drugs that are all identical in packaging, labeling, schedule of administration, appearance and odor.
Unblinding will only occur in the case of patient emergencies and at the conclusion of the study.
Area-under-the-curve (AUC) over time during first 12, 24, 48, 72, 96 and 168 hours for Pain on movement (POM) measured using a VAS Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain"
| Baseline and 12, 24, 48, 72, 96, 168 hours after initiating treatment |
| Pain-at-rest on VAS | Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain" | Baseline and 12, 24, 48, 72, 96, 168 hours after initiating treatment |
| Time to Meaningful and Optimal Reduction | The time taken to achieve a meaningful (30 %) and optimal (50 %) reduction of pain measured on the VAS for POM Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain" | Baseline and 12, 24, 48, 72, 96, 168 (192) hours after initiating treatment |
| Time to Complete Resolution of Pain | Time to complete resolution of pain, i. e. reaching a POM VAS value of 0 mm after start of study treatment Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain" | Baseline and 12, 24, 48, 72, 96, 168 (192) hours after initiating treatment |
| Responder Rate 1 | defined as the percentage of patients achieving ≥50% reduction from baseline in the VAS score for POM at 72 hours Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain" | 72 hours |
| Global Efficacy Assessments 1 by Patient | The global efficacy was assessed by the patients. The patients answered question below; -Considering all the ways this treatment has affected you since you started the clinical trial, how well are you doing? (5-point Likert scale: 0 = very good, 1 = good, 2 = fair, 3 = poor, and 4 = very poor). [Global efficacy assessment 1] | 48 h, 72 h, and 168 h |
| Global Efficacy Assessments 2 by Patient | The global efficacy was assessed by the patients. The patients answered question below -How do you rate this medication as treatment for your soft injury/contusion? (5-point Likert scale: 0 = excellent, 1 = very good, 2 = good, 3 = fair, and 4 = poor). [Global efficacy assessment 2] | 48 h, 72 h, and 168 h |
| Global Efficacy Assessments 1 by Investigator | The global efficacy was assessed by the investigator. -Considering all the ways this treatment has affected you since you started the clinical trial, how well are you doing? (5-point Likert scale: 0 = very good, 1 = good, 2 = fair, 3 = poor, and 4 = very poor). [Global efficacy assessment 1] | 48 h, 72 h, and 168 h |
| Use of Rescue Medication | Rescue medication (paracetamol, 500 mg tablets, up to 3000 mg daily) was allowed during the study, except for the 6 hours prior to V5 (72 h). | 0-168h |
| Resolution of Soft Tissue Injury/Contusion | Resolution of soft tissue injury/contusion was assessed by the Investigator at Visit 7 (168h). | 168h |
| SPID of POM VAS Changes | The sum of pain intensity difference (SPID) of POM on VAS changes over 0-24 h, 0-48 h, 0-72 h, and 0-96 h were calculated. SPID was calculated as the area under the curve of the VAS difference from baseline value. | 0-24 h, 0-48 h, 0-72 h, and 0-96 h |
| Responder Rate 2 at 168h | defined as the percentage of patients able to resume training/normal physical activity by 168 hours | 168h |
| Local Tolerability |
Local tolerability was assessed by the Investigator according to the following numerical scale: 0: No evidence of irritation
|
| 24, 48, 72, 96, 168h |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Type of injury | Count of Participants | Participants |
|
|
|
|
| Secondary | Pain-on-movement (POM) on VAS | Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain" | The Full Analysis Set (all randomized patients who received at least one dose of study drug). | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12, 24, 48, 72, 96, 168 hours after initiating treatment |
|
|
|
| Secondary | Area-under-the-curve for POM on VAS | Area-under-the-curve (AUC) over time during first 12, 24, 48, 72, 96 and 168 hours for Pain on movement (POM) measured using a VAS Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain" | The Full Analysis Set (all randomized patients who received at least one dose of study drug). | Posted | Mean | Standard Deviation | AUC of POM VAS pain (mm* h) | Baseline and 12, 24, 48, 72, 96, 168 hours after initiating treatment |
|
|
|
| Secondary | Pain-at-rest on VAS | Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain" | The Full Analysis Set (all randomized patients who received at least one dose of study drug). | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12, 24, 48, 72, 96, 168 hours after initiating treatment |
|
|
|
| Secondary | Time to Meaningful and Optimal Reduction | The time taken to achieve a meaningful (30 %) and optimal (50 %) reduction of pain measured on the VAS for POM Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain" | The Full Analysis Set (all randomized patients who received at least one dose of study drug). | Posted | Count of Participants | Participants | Baseline and 12, 24, 48, 72, 96, 168 (192) hours after initiating treatment |
|
|
|
| Secondary | Time to Complete Resolution of Pain | Time to complete resolution of pain, i. e. reaching a POM VAS value of 0 mm after start of study treatment Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain" | The Full Analysis Set (all randomized patients who received at least one dose of study drug). | Posted | Count of Participants | Participants | Baseline and 12, 24, 48, 72, 96, 168 (192) hours after initiating treatment |
|
|
|
| Secondary | Responder Rate 1 | defined as the percentage of patients achieving ≥50% reduction from baseline in the VAS score for POM at 72 hours Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain" | The Full Analysis Set (all randomized patients who received at least one dose of study drug). | Posted | Count of Participants | Participants | 72 hours |
|
|
|
| Secondary | Global Efficacy Assessments 1 by Patient | The global efficacy was assessed by the patients. The patients answered question below; -Considering all the ways this treatment has affected you since you started the clinical trial, how well are you doing? (5-point Likert scale: 0 = very good, 1 = good, 2 = fair, 3 = poor, and 4 = very poor). [Global efficacy assessment 1] | The Full Analysis Set (all randomized patients who received at least one dose of study drug). | Posted | Count of Participants | Participants | 48 h, 72 h, and 168 h |
|
|
|
| Secondary | Global Efficacy Assessments 2 by Patient | The global efficacy was assessed by the patients. The patients answered question below -How do you rate this medication as treatment for your soft injury/contusion? (5-point Likert scale: 0 = excellent, 1 = very good, 2 = good, 3 = fair, and 4 = poor). [Global efficacy assessment 2] | The Full Analysis Set (all randomized patients who received at least one dose of study drug). | Posted | Count of Participants | Participants | 48 h, 72 h, and 168 h |
|
|
|
| Secondary | Global Efficacy Assessments 1 by Investigator | The global efficacy was assessed by the investigator. -Considering all the ways this treatment has affected you since you started the clinical trial, how well are you doing? (5-point Likert scale: 0 = very good, 1 = good, 2 = fair, 3 = poor, and 4 = very poor). [Global efficacy assessment 1] | The Full Analysis Set (all randomized patients who received at least one dose of study drug). | Posted | Count of Participants | Participants | 48 h, 72 h, and 168 h |
|
|
|
| Secondary | Use of Rescue Medication | Rescue medication (paracetamol, 500 mg tablets, up to 3000 mg daily) was allowed during the study, except for the 6 hours prior to V5 (72 h). | The Full Analysis Set (all randomized patients who received at least one dose of study drug). | Posted | Count of Participants | Participants | 0-168h |
|
|
|
| Secondary | Resolution of Soft Tissue Injury/Contusion | Resolution of soft tissue injury/contusion was assessed by the Investigator at Visit 7 (168h). | The Full Analysis Set (all randomized patients who received at least one dose of study drug). | Posted | Count of Participants | Participants | 168h |
|
|
|
| Secondary | SPID of POM VAS Changes | The sum of pain intensity difference (SPID) of POM on VAS changes over 0-24 h, 0-48 h, 0-72 h, and 0-96 h were calculated. SPID was calculated as the area under the curve of the VAS difference from baseline value. | The Full Analysis Set (all randomized patients who received at least one dose of study drug). | Posted | Mean | Full Range | SPID of POM on VAS (mm x h) | 0-24 h, 0-48 h, 0-72 h, and 0-96 h |
|
|
|
| Secondary | Responder Rate 2 at 168h | defined as the percentage of patients able to resume training/normal physical activity by 168 hours | The Full Analysis Set (all randomized patients who received at least one dose of study drug). | Posted | Count of Participants | Participants | 168h |
|
|
|
| Other Pre-specified | Adhesive Power of the Patch | Adhesive power of the patch measured by a 5 point numerical scale (0= ≥ 90 % adhered, 1= ≥ 75 % to < 90 % adhered, 2= ≥ 50 % to < 75 % adhered, 3= > 0 % to <50 % adhered, 4=completely detached) at every visit except V1. | The Full Analysis Set (all randomized patients who received at least one dose of study drug). | Posted | Count of Units | Number of patches | 12h for day 1, 24h for day 1-5 and 7 after application of each patch | Number of patches | Number of patches |
|
|
|
| Other Pre-specified | Local Tolerability | Local tolerability was assessed by the Investigator according to the following numerical scale: 0: No evidence of irritation
| Safety Set (SAF) The safety set included all randomized patients who received at least one dose of the study drug. | Posted | Count of Participants | Participants | 24, 48, 72, 96, 168h |
|
|
|
| 98 |
| 0 |
| 98 |
| 9 |
| 98 |
| EG001 | Control Drug | Placebo patch that does not contain the active ingredient but is otherwise indistinguishable from the investigational drug Esflurbiprofen Hydrogel Patch | 0 | 102 | 0 | 102 | 16 | 102 |
| Infection | Infections and infestations | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment | Observed at application site |
|
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| 24 hour |
|
| 48 hour |
|
| 72 hour |
|
| 96 hour |
|
| 168 hour |
|
| 0-48 h |
|
| 0-72 h |
|
| 0-96 h |
|
| 0-168 h |
|
| 24 h |
|
| 48 h |
|
| 72 h |
|
| 96 h |
|
| 168 h |
|
| 24-48 |
|
| 48-72 |
|
| 72-96 |
|
| 96-192 |
|
| Not achieved |
|
| Time to optimal reduction of pain (h) (50 % or more) |
|
| 96-192h |
|
| Not achieved |
|
| Fair |
|
| Good |
|
| Very good |
|
| 72h |
|
| 168h |
|
| Good |
|
| Very good |
|
| Excellent |
|
| 72h |
|
| 168h |
|
| Fair |
|
| Good |
|
| Very good |
|
| 72h |
|
| 168h |
|
| 0-72 h |
|
| 0-96 h |
|
|
| 24h |
|
|
| 48h |
|
| 72h |
|
| 96h |
|
| 168h |
|
| ≥ 50 % to < 75 % adhered |
|
| ≥ 75 % to < 90 % adhered |
|
| ≥ 90 % adhered |
|