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| Name | Class |
|---|---|
| International Drug Development Institute | OTHER |
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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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heat Pain Stimuli A | Behavioral |
| ||
| Heat Pain Stimuli B |
| 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); the 11 NRS scale ranges from 0 (No pain) to 10 (pain as bad as you can imagine); the baseline APS (weekly mean of the daily average pain score) was computed on the 7 last days before Visit 2 with available APS values; similarly, the end-of-treatment APS (or APS Week 4) was computed on the 7 last days before Visit 4 with available APS values. | Time zero equals baseline (Day-28 to Day-14) up to Day 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's Change From Baseline of Pain Severity as Measured by the Brief Pain Inventory (BPI) | BPI is a self-reported scale that measures the severity of pain and the interference of pain on function (Charles S. Cleeland © 2009). In the short form of BPI, there are 4 questions assessing worst pain, least pain, actual pain and average pain in the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life. The interference scores range from 0 (does not interfere) to 10 (completely interferes). |
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Inclusion Criteria:
Inclusion Disease Criteria:
Diagnosis criterium for PNP: Patient with chronic PNP supported by a distinct neuroanatomical plausible distribution with sensory signs and symptoms, and consecutive to one of the following causes: a traumatic event, a surgical procedure (excluding limb amputation), radiculopathy, post- herpetic or post- zoster neuralgia, diabetic polyneuropathy or post chemotherapy. Diagnosis will have to be confirmed by the DN4 questionnaire at the screening visit (pain is considered as neuropathic if DN4 score ≥ 4)
Diagnosis criterium for OA: Patient with a unilateral or bilateral OA of the knee or hip diagnosed according to the American College of Rheumatology (ACR) criteria based on clinical and radiographic evidence (Altman et al. 1986). The clinical diagnosis of OA will be confirmed by the ACR clinical and radiographic criteria for classification of idiopathic OA of the knee or hip based upon the following criteria:
Exclusion Criteria:
Exclusion Disease Criteria for PNP patients:
Exclusion disease criteria for OA patients:
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| Name | Affiliation | Role |
|---|---|---|
| Alvaro Pereira | Tools4Patient | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ATC sa | Liège | 4000 | Belgium | |||
| CIC Clermont-Ferrand, CHU Clermont-Ferrand |
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| ID | Title | Description |
|---|---|---|
| FG000 | T4P1001 | Heat Pain Stimuli A Positive Video Administration of T4P1001 capsules: This treatment is given as add-on therapy to patient's regular analgesic treatment |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Positive Video | Behavioral |
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| Neutral Video | Behavioral |
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| Administration of T4P1001 capsules | Drug | This treatment is given as add-on therapy to patient's regular analgesic treatment |
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| Administration of Placebo capsules | Drug | This treatment is given as add-on therapy to patient's regular analgesic treatment |
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| Time zero equals baseline (Day-28 to Day-14) up to Day 29 |
| Patient's Change From Baseline of Investigator and Patient Global Assessment of Changes (IGAC and PGAC) | IGAC and PGAC are subjective evaluations using a NRS with 0 meaning "best condition" and 10 "worst condition" | Time zero equals baseline (Day-28 to Day-14) up to Day 29 |
| Patient's Change From Baseline of Heat Pain Threshold From Baseline to End of Treatment | celcius degree, arithmetic average of 6 tests. | Time zero equals baseline (Day 1) up to Day 29 |
| For Osteoarthritic Patients Only: Patient's Change From Baseline of Osteoarthritic Physical Function, Pain and Stiffness as Assessed by Western Ontario and MacMaster (WOMAC) Scales From Baseline to End of Treatment | The WOMAC (Bellamy et al., 1988) is a patient-rated instrument that measures OA symptoms. The questionnaire contains 5 pain questions, 2 stiffness questions, and 17 physical function questions (24 questions total). Each question utilizes a 5-points Numeric Rating Scale (NRS) between 0-4; from 0=none to 4=extreme. Range of possible subscale scores: pain=0-20, stiffness=0-8 and physical function=0-68; higher scores for each subscale indicate worse outcomes. The WOMAC was completed at each Visit except for Visit 5 by OA patients only. | Time zero equals baseline (Day-28 to Day-14) up to Day 29 |
| Clermont-Ferrand |
| 63003 |
| France |
| Eurofins Optimed | Gières | 38610 | France |
| Clinique Breteche | Nantes | 44046 | France |
| Institut Curie | Paris | 75005 | France |
| Centre d'Evaluation et Traitement de la Douleur, CHU Saint-Etienne | Saint-Etienne | 42055 | France |
Heat Pain Stimuli B
Neutral Video
Administration of Placebo capsules: This treatment is given as add-on therapy to patient's regular analgesic treatment
| COMPLETED |
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| NOT COMPLETED |
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3 patients who completed the study were excluded from the Baseline Analysis Population due to protocol violations. Therefore only 110 patients were included in the Baseline Analysis Population.
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| ID | Title | Description |
|---|---|---|
| BG000 | T4P1001 | Heat Pain Stimuli A Positive Video Administration of T4P1001 capsules: This treatment is given as add-on therapy to patient's regular analgesic treatment |
| BG001 | Placebo | Heat Pain Stimuli B Neutral Video Administration of Placebo capsules: This treatment is given as add-on therapy to patient's regular analgesic treatment |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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); the 11 NRS scale ranges from 0 (No pain) to 10 (pain as bad as you can imagine); the baseline APS (weekly mean of the daily average pain score) was computed on the 7 last days before Visit 2 with available APS values; similarly, the end-of-treatment APS (or APS Week 4) was computed on the 7 last days before Visit 4 with available APS values. | 3 patients who completed the study were excluded from the Analysis Population due to protocol violations. Therefore only 110 patients were included in the Analysis Population. | Posted | Mean | Standard Deviation | score on a scale | Time zero equals baseline (Day-28 to Day-14) up to Day 36 |
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| Secondary | Patient's Change From Baseline of Pain Severity as Measured by the Brief Pain Inventory (BPI) | BPI is a self-reported scale that measures the severity of pain and the interference of pain on function (Charles S. Cleeland © 2009). In the short form of BPI, there are 4 questions assessing worst pain, least pain, actual pain and average pain in the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life. The interference scores range from 0 (does not interfere) to 10 (completely interferes). | 3 patients who completed the study were excluded from the Analysis Population due to protocol violations. Therefore only 110 patients were included in the Analysis Population. | Posted | Mean | Standard Deviation | score on a scale | Time zero equals baseline (Day-28 to Day-14) up to Day 29 |
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| Secondary | Patient's Change From Baseline of Investigator and Patient Global Assessment of Changes (IGAC and PGAC) | IGAC and PGAC are subjective evaluations using a NRS with 0 meaning "best condition" and 10 "worst condition" | 3 patients who completed the study were excluded from the Analysis Population due to protocol violations. Therefore only 110 patients were included in the Analysis Population. | Posted | Mean | Standard Deviation | score on a scale | Time zero equals baseline (Day-28 to Day-14) up to Day 29 |
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| Secondary | Patient's Change From Baseline of Heat Pain Threshold From Baseline to End of Treatment | celcius degree, arithmetic average of 6 tests. | 3 patients who completed the study were excluded from the Analysis Population due to protocol violations. Therefore only 110 patients were included in the Analysis Population. | Posted | Mean | Standard Deviation | °C | Time zero equals baseline (Day 1) up to Day 29 |
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| Secondary | For Osteoarthritic Patients Only: Patient's Change From Baseline of Osteoarthritic Physical Function, Pain and Stiffness as Assessed by Western Ontario and MacMaster (WOMAC) Scales From Baseline to End of Treatment | The WOMAC (Bellamy et al., 1988) is a patient-rated instrument that measures OA symptoms. The questionnaire contains 5 pain questions, 2 stiffness questions, and 17 physical function questions (24 questions total). Each question utilizes a 5-points Numeric Rating Scale (NRS) between 0-4; from 0=none to 4=extreme. Range of possible subscale scores: pain=0-20, stiffness=0-8 and physical function=0-68; higher scores for each subscale indicate worse outcomes. The WOMAC was completed at each Visit except for Visit 5 by OA patients only. | Only OA sub-population of patients were included in the Analysis Population | Posted | Mean | Standard Deviation | score on a scale | Time zero equals baseline (Day-28 to Day-14) up to Day 29 |
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All safety analyses included the 58 PNP patients and the 56 OA patients enrolled into the study. Of note, the PNP patient N-043 and the OA patients O-040 and O-061 completed the study and took the treatment for the entire treatment period but were identified as protocol violators due to inclusion criteria not met.
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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 Positive Video Administration of T4P1001 capsules: This treatment is given as add-on therapy to patient's regular analgesic treatment | 0 | 58 | 14 | 58 | ||
| EG001 | Placebo | Heat Pain Stimuli B Neutral Video Administration of Placebo capsules: This treatment is given as add-on therapy to patient's regular analgesic treatment | 1 | 56 | 13 | 56 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Affect lability | Psychiatric disorders |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders |
| |||
| Back pain | Musculoskeletal and connective tissue disorders |
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| Pain in extremity | Musculoskeletal and connective tissue disorders |
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| Headache | Nervous system disorders |
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| Somnolence | Nervous system disorders |
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| Fatigue | General disorders |
| |||
| Nausea | General disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Scientific Officer | Tools4Patient | +32 71 91 | 94 00 | alvaro.pereira@tools4patient.com |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D010003 | Osteoarthritis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Units | Counts |
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