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An Exploratory Study of PRX167700 in Patients With Knee Osteoarthritis

Primary Purpose

Osteoarthritis, Knee

Status

Completed

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

PRX167700

Placebo

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring PRX167700, Osteoarthritis

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Proximagen Investigational Site
Proximagen Investigational Site
Proximagen Investigational Site
Proximagen Investigational Site
Proximagen Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PRX167700

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Efficacy:

Western Ontario and McMaster Universities (WOMAC)Questionnaire total score and subscales; Patient Global Impression of Change; Time to complete exercise; Serum C-reactive protein levels; Rescue medication use.

Safety

Safety and tolerability will be evaluated by assessing adverse events (AEs), clinical laboratory data, physical examinations, vital signs, and electrocardiograms (ECGs).

Full Information

NCT ID

NCT01945346

First Posted

September 13, 2013

Last Updated

August 25, 2015

Sponsor

Proximagen Limited

1. Study Identification

Unique Protocol Identification Number

NCT01945346

Brief Title

An Exploratory Study of PRX167700 in Patients With Knee Osteoarthritis

Official Title

A Double-Blind, Randomised, Exploratory Study to Investigate the Safety, Efficacy and Pharmacokinetics of PRX167700 in Subjects With Knee Osteoarthritis.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

September 2013 (undefined)

Primary Completion Date

April 2015 (Actual)

Study Completion Date

April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Proximagen Limited

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Up to 74 subjects will receive either PRX167700 or placebo (a dummy treatment) for 15 days. Subjects will need to stop taking their usual pain reliever medicines for at least 7 days before starting treatment to induce a 'flare' in osteoarthritis symptoms (but they will be allowed to continue to use paracetamol for immediate pain relief as needed throughout the trial). The effect of PRX167700 or placebo on knee pain will be assessed before and after exercise on Days 1, 3, 7 and 14. On Day 15, blood samples will be collected to measure levels of PRX167700 and assess its activity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee

Keywords

PRX167700, Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

74 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PRX167700

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

PRX167700

Intervention Description

Oral capsule

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral capsule

Primary Outcome Measure Information:

Title

Pain Intensity

Description

Time Frame

Study Days 0 [Baseline], 1, 3, 7 and 14

Secondary Outcome Measure Information:

Title

Efficacy:

Description

Time Frame

Study Days 0 [Baseline], 1, 3, 7 and 14

Title

Safety

Description

Safety and tolerability will be evaluated by assessing adverse events (AEs), clinical laboratory data, physical examinations, vital signs, and electrocardiograms (ECGs).

Time Frame

15 days

Other Pre-specified Outcome Measures:

Title

Pharmacokinetics

Description

Plasma concentration-time profiles and pharmacokinetic parameters, including (but not limited to) Cmax, tmax, area under the plasma concentration vs. time curve from time zero over the dosing interval, area under the concentration-time curve over the dose interval and to infinity, and, if possible, t½.will be determined.

Time Frame

Day 15

Title

Pharmacodynamics

Description

Biomarker activity following dosing

Time Frame

Day 15

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Proximagen Limited

Official's Role

Study Director

Facility Information:

Facility Name