Efficacy and Tolerability of Novel A2A Agonist in Treatment of Diabetic Neuropathic Pain

October 31, 2014 updated by: Swedish Orphan Biovitrum

A Double-blind, Placebo-controlled, Randomized, Parallel-group Study Evaluating the Efficacy and Tolerability of Oral BVT.115959, a Novel A2A Agonist, Versus Placebo in the Treatment of Diabetic Neuropathic Pain

The purpose of this study is to evaluate the efficacy and tolerability of BVT.115959 in diabetic patients with neuropathic pain who are either not on analgesia or are on stable analgesia in the month prior to entering the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The planned study is an exploratory study which aims to provide proof of the efficacy of BVT.115959 in the reduction of the symptoms of pain. Thus, the primary objective is to evaluate the anticipated analgesic properties of BVT.115959 in patients with diabetic neuropathic pain and to confirm its activity against placebo.

The study will evaluate the efficacy and tolerability of oral BVT.115959 7 mg administered three times a day (t.i.d.) versus a matching placebo in diabetic patients with neuropathic pain who are either not on analgesia or are on stable analgesia in the month prior to entering the study and who are being maintained on stable analgesia throughout the study. Eligible subjects will be randomized in a ratio of 2:1 (BVT.115959: placebo).

The study consists of a 1-week screening/baseline period, a 4-week treatment period and a 1 week follow-up period.

Study Type

Interventional

Enrollment (Actual)

193

Phase

  • Phase 2

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

  • Czech Republic
      • Ceske Budejovice, Czech Republic
        • Biovitrum Investigational Site
      • Litomerice, Czech Republic
        • Biovitrum Investigational Site
      • Plzen, Czech Republic
        • Biovitrum Investigational Site
      • Praha 4, Czech Republic
        • Biovitrum Investigational Site
      • Praha 8, Czech Republic
        • Biovitrum Investigational Site
  • Germany
      • Bad Kreuznach, Germany
        • Biovitrum Investigational Site
      • Berlin, Germany
        • Biovitrum Investigational Site
      • Dortmund, Germany
        • Biovitrum Investigational Site
      • Gelsenkirchen, Germany
        • Biovitrum Investigational Site
      • Hamburg, Germany
        • Biovitrum Investigational Site
      • Mainz, Germany
        • Biovitrum Investigational Site
      • Mannheim, Germany
        • Biovitrum Investigational Site
      • Neumunster, Germany
        • Biovitrum Investigational Site
  • South Africa
      • Bloemfontein, South Africa
        • Biovitrum Investigational Site
      • Durban, South Africa
        • Biovitrum Investigational Site
      • Kenilworth, South Africa
        • Biovitrum Investigational Site
      • Kraaifontein, South Africa
        • Biovitrum Investigational Site
      • Polokwane, South Africa
        • Biovitrum Investigational Site
      • Pretoria, South Africa
        • Biovitrum Investigational Site
      • Somerset West, South Africa
        • Biovitrum Investigational Site
      • Wynberg, South Africa
        • Biovitrum Investigational Site

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A diagnosis of type 1 or 2 diabetes mellitus and documented painful, symmetrical, sensorimotor polyneuropathy for at least 6 months
  • Either no analgesic medication or on stable analgesic medication for at least 4 weeks

Exclusion Criteria:

  • Female patients who are fertile and of child-bearing potential
  • Clinically significant or unstable hepatic, respiratory, renal, hematologic, cardiovascular or peripheral vascular disease
  • Painful conditions that may confound the evaluation of neuropathic pain

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: BVT.115959
Capsules containing 7 mg BVT.115959 administered orally three times daily
Drug: BVT.115959
PLACEBO_COMPARATOR: Placebo
Placebo capsules administered orally three times daily
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in mean 24-hour pain intensity score from baseline using an 11-point Likert NRS assessed over the preceding 24 hours immediately upon awakening in the morning

Secondary Outcome Measures

Outcome Measure
Quality of life
Present pain intensity using an 11-point Likert NRS assessed at bedtime
Short-Form McGill Pain Questionnaire parameters
Weekly mean sleep interference score
Clinical Global Impression of Change and Patient's Global Impression of Change
Mood stability
Time to study withdrawal

Collaborators and Investigators

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

Sponsor

Swedish Orphan Biovitrum

Investigators

  • Study Director: Keith Bragman, MD FRCP FRCPath FFPM, Swedish Orphan Biovitrum

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

May 1, 2007

Primary Completion (ACTUAL)

December 1, 2007

Study Completion (ACTUAL)

January 1, 2008

Study Registration Dates

First Submitted

March 26, 2007

First Submitted That Met QC Criteria

March 26, 2007

First Posted (ESTIMATE)

March 27, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

November 2, 2014

Last Update Submitted That Met QC Criteria

October 31, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BVT.115959-005

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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