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

NCT ID: NCT02612233

Last Updated: 2016-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2016-07-31

Brief Summary

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.

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.

Conditions

Hand Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Pregabalin

Pregabalin 150mg ON week 1 increased to Pregabalin 300mg ON weeks 2-11 then decrease to Pregabalin 150mg ON week 12 then STOP

Group Type: ACTIVE_COMPARATOR

Pregabalin or Duloxetine or Placebo

Intervention Type: DRUG

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

Duloxetine

Duloxetine 30mg ON week 1 increase to Duloxetine 60mg weeks 2-11 then decrease to Duloxetine 30mg ON week 12 then STOP

Group Type: ACTIVE_COMPARATOR

Pregabalin or Duloxetine or Placebo

Intervention Type: DRUG

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

Placebo

1 capsule ON week 1- increase to 2 capsules ON week 2-11 then decrease to 1 capsule ON week 12 then STOP.

Group Type: PLACEBO_COMPARATOR

Pregabalin or Duloxetine or Placebo

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

DUPRO Capsules

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rosetrees Trust

OTHER

Sponsor Role: collaborator

St George's, University of London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nidhi Sofat, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

St George's, University of London

Locations

Hotung Centre for Musculoskeletal Diseases

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

2011-003803-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

11.0126

Identifier Type: -

Identifier Source: org_study_id