Pain Management in Osteoarthritis Using the Centrally Acting Analgesics Duloxetine and Pregabalin (DUPRO)

July 19, 2016 updated by: St George's, University of London
Osteoarthritis is the most common form of arthritis worldwide. Specifically, osteoarthritis of the hands affects millions of people and is a major cause of hand disability and pain. Despite this, there are currently no treatments that delay or halt the development of osteoarthritis. Pain is one of the major symptoms of osteoarthritis and pain management is an important factor to consider in the treatment of this condition. Treatments for pain in osteoarthritis consists of local injections, anti-inflammatory gels or painkillers such as paracetamol. However, most people with osteoarthritis still have pain despite these treatments.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Recent scientific studies have suggested that people with hand osteoarthritis not only feel pain in their hand joints, they also appear to have increased signals in their brain pain processing pathways. At St George's, University of London, the investigators have been conducting studies to find out which brain regions are activated in subjects with hand osteoarthritis. The investigators have found that certain brain regions (thalamus, insula, cingulate and somatosensory cortex) are activated during painful tasks in patients with hand osteoarthritis but not in healthy people. In this study the investigators will establish whether drugs that inhibit pain processing pathways in the brain can help. Patients who are still having pain despite their usual painkillers will be randomly divided into 3 groups: one group will receive a placebo, the other 2 groups will receive one of two different drugs, duloxetine or pregabalin. Participants will be assessed using questionnaires and a brain scan (functional MRI) before and after 13 weeks of taking the tablets. This study will help us to understand the ways in which people feel pain in osteoarthritis. If our trial proves successful,drugs that dampen central pain pathways could be used in combination with local pain-relieving drugs to improve treatment and reduce disability in patients with hand osteoarthritis.

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SW17 ORE
        • Hotung Centre for Musculoskeletal Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants fulfilling the American College of Rheumatology (ACR) criteria for the diagnosis of hand osteoarthritis
  • Participants with hand osteoarthritis presenting to rheumatology outpatient clinics and primary care.
  • Participants will be right or left handed
  • Male or female
  • Age between 40 and 75
  • Participants will be on usual care for hand osteoarthritis including paracetamol and/or non-steroidal anti-inflammatory drugs

Exclusion Criteria:

  • Participants with other rheumatological diagnoses e.g. rheumatoid arthritis
  • Current or planned pregnancy
  • Contraindications to duloxetine or pregabalin
  • History of depression
  • Recent surgery
  • Previous use of duloxetine and/or pregabalin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pregabalin
Pregabalin 150mg ON week 1 increased to Pregabalin 300mg ON weeks 2-11 then decrease to Pregabalin 150mg ON week 12 then STOP
Drug: Pregabalin or Duloxetine or Placebo
This is a randomized, double blind placebo controlled trial with a head-to-head comparison of duloxetine vs pregabalin vs placebo over-encapsulated to prevent unblinding of treatment arm
Other Names:
  • DUPRO Capsules
Active Comparator: Duloxetine
Duloxetine 30mg ON week 1 increase to Duloxetine 60mg weeks 2-11 then decrease to Duloxetine 30mg ON week 12 then STOP
Drug: Pregabalin or Duloxetine or Placebo
This is a randomized, double blind placebo controlled trial with a head-to-head comparison of duloxetine vs pregabalin vs placebo over-encapsulated to prevent unblinding of treatment arm
Other Names:
  • DUPRO Capsules
Placebo Comparator: Placebo
1 capsule ON week 1- increase to 2 capsules ON week 2-11 then decrease to 1 capsule ON week 12 then STOP.
Drug: Pregabalin or Duloxetine or Placebo
This is a randomized, double blind placebo controlled trial with a head-to-head comparison of duloxetine vs pregabalin vs placebo over-encapsulated to prevent unblinding of treatment arm
Other Names:
  • DUPRO Capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Australian/Canadian Hand Osteoarthritis Index score (AUSCAN)
Time Frame: 12 weeks
The AUSCAN measures pain and hand function. Differences between baseline AUSCAN and after treatment will be recorded for each participant to assess for improvement in AUSCAN pain and function score after the trial intervention.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain magnetic resonance imaging (MRI)
Time Frame: Baseline and 12 weeks after treatment
Changes between baseline MRI and post-treatment after 12 weeks of intervention will be measured using functional neuroimaging to assess pain center activation before and after intervention.
Baseline and 12 weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St George's, University of London

Collaborators

Rosetrees Trust

Investigators

  • Principal Investigator: Nidhi Sofat, MBBS, PhD, St George's, University of London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

November 18, 2015

First Submitted That Met QC Criteria

November 20, 2015

First Posted (Estimate)

November 23, 2015

Study Record Updates

Last Update Posted (Estimate)

July 20, 2016

Last Update Submitted That Met QC Criteria

July 19, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11.0126
  • 2011-003803-39 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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