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

NCT02612233 | Completed Phase 4 DMC

• 2 other identifiers: 11.01262011-003803-39
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Hand Osteoarthritis

Keywords

Pain

Outcome Measures

Primary Outcomes (1)

• Australian/Canadian Hand Osteoarthritis Index score (AUSCAN)

  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 Outcomes (1)

• Brain magnetic resonance imaging (MRI)

  Baseline and 12 weeks after treatment

Study Arms (3)

Pregabalin

ACTIVE COMPARATOR

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

Duloxetine

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Pregabalin or Duloxetine or Placebo 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

Also known as: DUPRO Capsules

Duloxetine; Placebo; Pregabalin

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St George's, University of London: lead
• Rosetrees Trust: collaborator

Study Sites (1)

Hotung Centre for Musculoskeletal Diseases

London, SW17 ORE, United Kingdom

Location

MeSH Terms

Conditions

Pain

Interventions

Pregabalin; Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Thiophenes; Sulfur Compounds; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Nidhi Sofat, MBBS, PhD

  St George's, University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: November 23, 2015
• Study Start: September 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 20, 2016

Record last verified: 2016-07

Locations

GB (1)