NCT02712957

Brief Summary

The purpose of this study is to assess NEO6860, a modality selective TRPV1 antagonist, in patients with pain associated with osteoarthritis of the knee.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_2 pain

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 18, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2016

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 24, 2016

Completed
Last Updated

March 13, 2017

Status Verified

March 1, 2017

Enrollment Period

9 months

First QC Date

March 9, 2016

Last Update Submit

March 10, 2017

Conditions

PainOsteoarthritis of the Knee

Outcome Measures

Primary Outcomes (1)

  • Mean change in Numerical Rating Scale (NRS, 0-10) from baseline after the staircase test to 8 hours post first dose after the staircase test on the index knee.

    Patients are asked to step fully up onto a 8-inch (20 cm) high platform with both feet and back down a total of 24 times.

    8 hours post dosing. This endpoint will be collected 3 times, 8 hours post dosing for each period: NEO6860, naproxen and placebo.

Secondary Outcomes (2)

  • WOMAC 3.1 Index Likert pain subscale

    from baseline (screening) to 24 hour recall post 1 day treatment at each of the 3 periods

  • Patient's Global Impression of Change (PGIC)

    24 hour post 1 day treatment at each of the 3 periods

Study Arms (3)

NEO6860

EXPERIMENTAL

NEO6860 is provided as a powder in individual containers to be reconstituted as a suspension. In this arm patients will receive both NEO6860 and a placebo of naproxen.

Drug: NEO6860Drug: Naproxen placebo

Placebo

PLACEBO COMPARATOR

In this arm, patients will receive both placebo: oral liquid suspension (NEO6860 placebo) and capsule (naproxen placebo).

Drug: NEO6860 placeboDrug: Naproxen placebo

Naproxen

ACTIVE COMPARATOR

Naproxen is provided as over-encapsulated tablets using a commercially approved medication. In this arm patients will receive both naproxen and a placebo of NEO6860.

Drug: NEO6860 placeboDrug: Naproxen

Interventions

NEO6860DRUG

TRPV1 antagonist

NEO6860
NEO6860 placeboDRUG

Inactive substance

NaproxenPlacebo
NaproxenDRUG

NSAID

Naproxen
Naproxen placeboDRUG

inactive substance

NEO6860Placebo

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index (BMI) between 18.0 and 35.0 kg/m2 inclusive;
  • Patients diagnosed with osteoarthritis of the knee, according to American College of Rheumatology (ACR) guidelines, by meeting at least 3 of the following: age \> 50, morning stiffness \< 30 minutes, crepitus on active motion, bone tenderness, bone enlargement, no palpable warmth of synovium;
  • Grade I, II or III using Kellgren-Lawrence classification on an X-Ray of the knee
  • WOMAC pain subscale ≥ 8
  • R square of the Focused Analgesia Selection Task (FAST) outcome value greater than 0.70

You may not qualify if:

  • Patients with, or with a history of, any clinically significant disorders (including fibromyalgia and other painful disorders) which may interfere with the primary objectives of the study
  • Patients treated in the previous 3 months with topical capsaicin or intra-articular corticosteroids;
  • Patients with a contra-indication for the use of Naproxen or acetaminophen;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Diex Recherche Montreal Inc

Montreal, Quebec, H2Y 1S1, Canada

Location

Algorithme Pharma

Montreal, Quebec, H3P 3P1, Canada

Location

Diex Recherche Sherbrooke Inc

Sherbrooke, Quebec, J1H 1Z1, Canada

Location

MeSH Terms

Conditions

PainOsteoarthritis, Knee

Interventions

Naproxen

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsOsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Naphthaleneacetic AcidsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Dan A Chiche, MD

    Neomed Institute

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2016

First Posted

March 18, 2016

Study Start

March 1, 2016

Primary Completion

November 17, 2016

Study Completion

November 24, 2016

Last Updated

March 13, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(3)