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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00452777
First Posted: March 27, 2007
Last Update Posted: November 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Swedish Orphan Biovitrum
  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 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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

Enrollment: 193
Study Start Date: May 2007
Study Completion Date: January 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier: NCT00452777     History of Changes
Other Study ID Numbers: BVT.115959-005
First Submitted: March 26, 2007
First Posted: March 27, 2007
Last Update Posted: November 3, 2014
Last Verified: October 2014

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