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

This study has been completed.
Sponsor:
Information provided by:
Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier:
NCT00452777
First received: March 26, 2007
Last updated: January 15, 2008
Last verified: January 2008
  Purpose

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.


Condition Intervention Phase
Diabetic Neuropathic Pain
Drug: BVT.115959
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Swedish Orphan Biovitrum:

Primary Outcome Measures:
  • 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:
  • 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
  • Quality of life
  • Mood stability
  • Time to study withdrawal

Estimated Enrollment: 228
Study Start Date: May 2007
Study Completion Date: January 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00452777

Locations
Czech Republic
Biovitrum investigational site
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
Germany
Biovitrum Investigational Site
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
South Africa
Biovitrum Investigational Site
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
Sponsors and Collaborators
Swedish Orphan Biovitrum
Investigators
Study Director: Keith Bragman, MD FRCP FRCPath FFPM Swedish Orphan Biovitrum
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00452777     History of Changes
Other Study ID Numbers: BVT.115959-005
Study First Received: March 26, 2007
Last Updated: January 15, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Czech Republic: State Institute for Drug Control
United Kingdom: Medicines and Healthcare Products Regulatory Agency
South Africa: Medicines Control Council

Keywords provided by Swedish Orphan Biovitrum:
Diabetic neuropathy, painful
Adenosine A2A receptor

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014