A Proof of Concept Study to Investigate the Effect of T4P1001 Treatment in Patients With Peripheral Neuropathic Pain or Osteoarthritic Pain of Knee or Hip

Tools4Patient6 sites in 2 countries114 target enrollmentJune 2015

ConditionsPeripheral Neuropathies Osteoarthritis

InterventionsHeat Pain Stimuli A Positive Video Administration of T4P1001 capsules Heat Pain Stimuli B Neutral Video Administration of Placebo capsules

DrugsAdministration of T4P1001 capsules Administration of Placebo capsules

Overview

Phase: N/A
Intervention: Heat Pain Stimuli A
Conditions: Peripheral Neuropathies
Sponsor: Tools4Patient
Enrollment: 114
Locations: 6
Primary Endpoint: 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
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

June 2015

End Date

October 2016

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Tools4Patient

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Are men or women of at least 18 years of age
•Diagnosed with Peripheral Neuropathic Pain (PNP) or knee or hip pain attributed to Osteoarthritis (OA) since at least 6 months
•Affiliated with national welfare
•Reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
•Have given written informed consent approved by the relevant Ethics Committee (EC) governing the study sites
•Patients will be required to report pain with a score between 4 and 8 inclusive on the mean Average Pain Score (APS) during the baseline period preceding randomization and to have completed at least 10 days of pain assessments in their diary between Visit 1 and Visit
•If more than 10 days were completed, the mean APS will be calculated on the last 10 ones.
•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

•Patient changed his/her " regular analgesic therapy " for PNP or OA in the last 4 weeks prior to Visit 1 or during the study.
•Patient's regular analgesic treatment for PNP or OA consists of more than 2 different treatments, with neurostimulation being considered as an analgesic treatment for PNP.
•Patient reported unvariable APS and WPS scores between Visit 1 and Visit 2 (systematically the same APS score and the same WPS score reported).
•Use or plan to use non-topical corticosteroids during the study.
•Have initiated (or plan to initiate) a program (or modify an existing program in frequency and/or intensity) of physiotherapy or behavioral therapy such as pain self-management, hypnosis, sophrology, meditation program within 2 weeks prior to Visit 1 or during the study.
•Pregnant, breastfeeding, or willing to be pregnant within 3 months.
•Patients with a current or recent history, as determined by the Investigator, of severe, progressive, and/or uncontrolled renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease which would interfere with the patient's participation in the study.
•Uncontrolled epilepsy.
•Any current primary psychiatric condition, including depression or personality disorders (such as Axe II of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV); personality disorders and mental retardation).
•Alcohol dependence or regular use of known drugs of abuse (e.g., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, and phencyclidine).

Arms & Interventions

T4P1001

Intervention: Heat Pain Stimuli A

T4P1001

Intervention: Positive Video

T4P1001

Intervention: Administration of T4P1001 capsules

Placebo

Intervention: Heat Pain Stimuli B

Placebo

Intervention: Neutral Video

Placebo

Intervention: Administration of Placebo capsules

Outcomes

Primary Outcomes

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

Time Frame: Time zero equals baseline (Day-28 to Day-14) up to Day 36

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.

Secondary Outcomes

Patient's Change From Baseline of Investigator and Patient Global Assessment of Changes (IGAC and PGAC)(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(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(Time zero equals baseline (Day-28 to Day-14) up to Day 29)
Patient's Change From Baseline of Pain Severity as Measured by the Brief Pain Inventory (BPI)(Time zero equals baseline (Day-28 to Day-14) up to Day 29)