Brief Summary

This is an exploratory study to evaluate a new anti-inflammatory drug, PRX167700, in subjects with painful osteoarthritis of the knee. The purpose of this study is to investigate if PRX167700 improves the pain from osteoarthritis of the knee, and to assess its safety and tolerability. The study will also investigate PRX167700 pharmacokinetics.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Sep 2013

Geographic Reach

1 country

5 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

1.6 years study duration

Study Start

First participant enrolled

September 1, 2013

Completed

12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2013

Completed

5 days until next milestone

First Posted

Study publicly available on registry

September 18, 2013

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed

Last Updated

August 26, 2015

Status Verified

August 1, 2015

Enrollment Period

1.6 years

First QC Date

September 13, 2013

Last Update Submit

August 25, 2015

Conditions

Osteoarthritis, Knee

Keywords

PRX167700Osteoarthritis

Outcome Measures

Primary Outcomes (1)

Pain Intensity
Measured at rest and after exercise at 1, 2 and 3 hours post-dose. Measured using 11-point numerical rating scale (NRS)ranging from 0 to 10 where 0 represents no pain and 10 represents the worst possible pain
Study Days 0 [Baseline], 1, 3, 7 and 14

Secondary Outcomes (2)

Efficacy:
Study Days 0 [Baseline], 1, 3, 7 and 14
Safety
15 days

Other Outcomes (2)

Pharmacokinetics
Day 15
Pharmacodynamics
Day 15

Study Arms (2)

PRX167700

EXPERIMENTAL

Drug: PRX167700

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

PRX167700DRUG

Oral capsule

PRX167700

PlaceboDRUG

Oral capsule

Placebo

Eligibility Criteria

Age45 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Body Mass Index (BMI) between 20 and 35 kg/m2, inclusive.
Symptomatic primary OA of the knee for at least 3 months prior to Screening according to the American College of Rheumatology (ACR) criteria.
Diagnosis of OA of the knee based on ACR criteria with X-ray confirmation (a Kellgren-Lawrence X-ray grade of ≥2) in the target knee joint.
Use of analgesics for the treatment of knee OA for at least 4 out of 7 days in each of the 4 weeks preceding the Screening visit.
Willing and able to discontinue all current analgesic therapy, including over the counter (OTC) pain medications and topical analgesics for OA pain, for a period beginning at Screening and continuing for the entire duration of the study.
Able to walk 100 metres on a flat course without rest and unaided.
A self-rated Pain Intensity score in the target knee joint of between 3 and 8, inclusive, immediately after a timed 100 metres walk on a flat course.
Able to provide written informed consent to participate in the study and, in the opinion of the investigator, able to read, comprehend and record information as required by the protocol.

You may not qualify if:

Secondary causes of arthritis of the knee, disease of the spine or of lower extremity joints (other than OA), knee pain characteristic of neuropathic pain.
Lower extremity surgery (including arthroscopy) within 6 months prior to Screening or scheduled for surgery of any kind during the study.
Significant injury to the target knee joint within 12 months prior to Screening.
Known history of hypersensitivity or intolerance to paracetamol or lactose.
Oral corticosteroids within 1 month of Screening
Therapeutic injections into the target knee joint within previous 3 months. Intra-articular corticosteroid injections into any other site within 1 month or intra-muscular corticosteroid injections within 3 months.
Start or change in dosing regimen of other therapies for OA within 3 months of Screening.
Start or change in an established physiotherapy programme within 2 weeks of Screening (Visit 1) or during the course of the study. An established physiotherapy program may be continued throughout the study period if unchanged in frequency and intensity.
Any significant clinical or biological abnormality (other than those related to OA) which would preclude safe participation in this study.

Contact the study team to confirm eligibility.