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The purpose of this clinical trial conducted in patients suffering from chronic pain is to study the relationship between individual patients' profile and their analgesic response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T4P1001 | Active Comparator |
| |
| Placebo | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heat pain stimuli A | Behavioral |
| ||
| Video A |
| Measure | Description | Time Frame |
|---|---|---|
| Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Daily Average Pain Scores (APS) During 4 Weeks of Treatment | 11-point Numeric Rating Scale (NRS). Scale from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine. Lower values represent a better outcome. Unit: arithmetic average of 7 days of a 11-point NRS | Time zero equals baseline (Day 1) up to Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Daily Worst Pain Scores (WPS) | 11-point Numeric Rating Scale (NRS) Scale from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine. Lower values represent a better outcome. Unit: arithmetic average of 7 days of a 11-point NRS | Time zero equals baseline (Day 1) up to Day 42 |
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Inclusion Criteria:
PNP disease diagnosis inclusion criteria:
Exclusion Criteria:
Exclusion criteria related to PNP:
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| Name | Affiliation | Role |
|---|---|---|
| Alvaro Pereira | Tools4Patient | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIC Clermont-Ferrand, CHU Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | T4P1001 | Heat pain stimuli A Video A Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic |
| FG001 | Placebo | Heat pain stimuli B Video B Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | T4P1001 | Heat pain stimuli A Video A Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic |
| BG001 | Placebo | Heat pain stimuli B Video B Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic |
| 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 | Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Daily Average Pain Scores (APS) During 4 Weeks of Treatment | 11-point Numeric Rating Scale (NRS). Scale from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine. Lower values represent a better outcome. Unit: arithmetic average of 7 days of a 11-point NRS | Posted | Mean | Standard Deviation | units on a scale | Time zero equals baseline (Day 1) up to Day 42 |
|
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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 | T4P1001 | Heat pain stimuli A Video A Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Migraine | Nervous system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Alvarez | Tools4Patient | +32 71 14 | 02 00 | stephanie.alvarez@tools4patient.com |
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| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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|
| Administration of T4P1001 capsules | Drug | This treatment is given as add on therapy to patients' regular analgesic |
|
| Heat pain stimuli B | Behavioral |
|
| Video B | Behavioral |
|
| Administration of placebo capsules | Drug | This treatment is given as add on therapy to patients' regular analgesic |
|
| Patient's Change From Baseline of Investigator Global Assessment of Change (IGAC) | IGAC is an investigator subjective evaluation of patient condition using a NRS from 0 to 10 with 0 meaning best and 10 worst Lower values represent a better outcome. | Time zero equals baseline (Day 1) up to Day 28 |
| Patient's Change of Pain Intensity After Heat Pain Stimuli From Baseline to End of Treatment Period | 11-point Numeric Rating Scale (NRS) from 0 to 10; 0 meaning no pain, 10 pain as bad as you can imagine Lower values represent a better outcome Unit: arithmetic average on 6 reported scores per Visit. | Time zero equals baseline (Day 1) up to Day 28 |
| Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Brief Pain Inventory (BPI). | Arithmetic average of 3 questions on an 11-point Numeric Rating Scale (NRS) from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine. Lower values represent a better outcome | Time zero equals baseline (Day 1) up to Day 28 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Secondary | Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Daily Worst Pain Scores (WPS) | 11-point Numeric Rating Scale (NRS) Scale from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine. Lower values represent a better outcome. Unit: arithmetic average of 7 days of a 11-point NRS | Posted | Mean | Standard Deviation | units on a scale | Time zero equals baseline (Day 1) up to Day 42 |
|
|
|
|
| Secondary | Patient's Change From Baseline of Investigator Global Assessment of Change (IGAC) | IGAC is an investigator subjective evaluation of patient condition using a NRS from 0 to 10 with 0 meaning best and 10 worst Lower values represent a better outcome. | Posted | Mean | Standard Deviation | units on a scale | Time zero equals baseline (Day 1) up to Day 28 |
|
|
|
|
| Secondary | Patient's Change of Pain Intensity After Heat Pain Stimuli From Baseline to End of Treatment Period | 11-point Numeric Rating Scale (NRS) from 0 to 10; 0 meaning no pain, 10 pain as bad as you can imagine Lower values represent a better outcome Unit: arithmetic average on 6 reported scores per Visit. | Posted | Mean | Standard Deviation | units on a scale | Time zero equals baseline (Day 1) up to Day 28 |
|
|
|
|
| Secondary | Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Brief Pain Inventory (BPI). | Arithmetic average of 3 questions on an 11-point Numeric Rating Scale (NRS) from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine. Lower values represent a better outcome | Posted | Mean | Standard Deviation | units on a scale | Time zero equals baseline (Day 1) up to Day 28 |
|
|
|
|
| 0 |
| 21 |
| 7 |
| 21 |
| EG001 | Placebo | Heat pain stimuli B Video B Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic | 0 | 21 | 6 | 21 |
| Headache | Nervous system disorders |
|
| Cervical pain | Musculoskeletal and connective tissue disorders |
|
Specific agreement as part of Eureka project
| D013568 | Pathological Conditions, Signs and Symptoms |