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

NCT02459197 NA COMPLETED Results posted

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

Details

Lead sponsor	Tools4Patient
Phase	NA
Status	COMPLETED
Enrolment	114
Start date	2015-06
Completion	2016-10

Conditions

• Peripheral Neuropathies
• Osteoarthritis

Interventions

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

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 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.

Countries

Belgium, France