NCT00370656

Brief Summary

The purpose of this study is to assess the effectiveness of pregabalin, duloxetine and amitriptyline compared with placebo in reducing pain in diabetic patients as assessed by Brief Pain Inventory (BPI).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for phase_2 diabetes-mellitus

Timeline
Completed

Started Feb 2007

Geographic Reach
1 country

3 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

First Submitted

Initial submission to the registry

August 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2006

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

November 17, 2009

Status Verified

November 1, 2009

Enrollment Period

2.2 years

First QC Date

August 31, 2006

Last Update Submit

November 16, 2009

Conditions

Diabetes MellitusPeripheral Neuropathies

Keywords

Diabetic Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

  • Whether there is a reduction in subjective pain as assessed by the Brief Pain Inventory.

    December 2008

Secondary Outcomes (1)

  • Whether there has been an improvement in sleep continuity and subjective sleep, morning after cognitive and psychomotor performance, and quality of life (QoL).

    December 2008

Interventions

PregabalinDRUG

capsule, 150mg bd, 300mg bd

DuloxetineDRUG

Capsule, 60mg on, 60mg bd

AmitriptylineDRUG

Capsule. 25 mg bd, 25 mg om and 50 mg on

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or above
  • Have a diagnosis of Diabetes mellitus for at least a year
  • Agree not to smoke whilst resident in the CRC
  • Able to understand the patient information sheet and provide written informed consent
  • Score above 12 on the LANSS
  • Have neuropathic pain of diabetic origin
  • Score above 25 on MMSE
  • Willing to withdraw, under the guidance of their diabetologist, from any current pain medication prior to their first visit to the sleep laboratory. Duration of withdrawal will be at least equivalent to 5 half-lives and will be of a relevant duration given the particular medication used.

You may not qualify if:

  • There is evidence of an end stage disease of a major system (hepatic, renal, respiratory, haematologic (PA), immunologic, cardiovascular, inflammatory, rheumatology, active infections, peripheral vascular disease, untreated endocrine(hypothyroid)
  • There is evidence of a recent ischaemic event
  • There is evidence of recurrent and/or severe hypoglycemia requiring assistance in last 3 years
  • Evidence of sleep pathology that would interfere with the assessment of treatment (assessed on habituation night)
  • Currently receiving treatment for malignancy
  • Suffer from seizures including epilepsy
  • There is evidence of a history of dependence on or abuse of alcohol/recreational drugs
  • Need to use a wheel chair (incompatible with studies in a sleep laboratory)
  • Involved in a clinical trial in last 3 months
  • Pregnant, lactating or inadequate contraception
  • Vision inadequate for the performance tests (as assessed at screening)
  • Colour Blind
  • Will not co-operate with study procedures
  • Will not give permission to inform GP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Royal Bournemouth Hospital

Bournemouth, Dorset, BH7 7DW, United Kingdom

Location

Poole General Hospital

Poole, Dorset, BH15 2JB, United Kingdom

Location

University of Surrey Clinical Research Centre

Guildford, Surrey, GU2 7XP, United Kingdom

Location

Related Publications (1)

  • Boyle J, Eriksson ME, Gribble L, Gouni R, Johnsen S, Coppini DV, Kerr D. Randomized, placebo-controlled comparison of amitriptyline, duloxetine, and pregabalin in patients with chronic diabetic peripheral neuropathic pain: impact on pain, polysomnographic sleep, daytime functioning, and quality of life. Diabetes Care. 2012 Dec;35(12):2451-8. doi: 10.2337/dc12-0656. Epub 2012 Sep 18.

    PMID: 22991449DERIVED

MeSH Terms

Conditions

Diabetes MellitusPeripheral Nervous System Diseases

Interventions

PregabalinDuloxetine HydrochlorideAmitriptyline

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsThiophenesSulfur CompoundsHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDibenzocycloheptenesBenzocycloheptenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Professor AN Nicholson

    University of Surrey

    PRINCIPAL INVESTIGATOR

  • Dr D Kerr

    Royal Bournemouth Hospital

    PRINCIPAL INVESTIGATOR

  • Dr D Coppini

    Poole General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 31, 2006

First Posted

September 1, 2006

Study Start

February 1, 2007

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

November 17, 2009

Record last verified: 2009-11

Locations

GB(3)