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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier:
NCT00452777
First received: March 26, 2007
Last updated: October 31, 2014
Last verified: October 2014

March 26, 2007
October 31, 2014
May 2007
December 2007   (final data collection date for primary 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
Same as current
Complete list of historical versions of study NCT00452777 on ClinicalTrials.gov Archive Site
  • 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
  • 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
Not Provided
Not Provided
 
Efficacy and Tolerability of Novel A2A Agonist in Treatment of Diabetic Neuropathic Pain
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetic Neuropathic Pain
  • Drug: BVT.115959
  • Drug: Placebo
  • Experimental: BVT.115959
    Capsules containing 7 mg BVT.115959 administered orally three times daily
    Intervention: Drug: BVT.115959
  • Placebo Comparator: Placebo
    Placebo capsules administered orally three times daily
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
193
January 2008
December 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Germany,   South Africa
 
NCT00452777
BVT.115959-005
Yes
Swedish Orphan Biovitrum
Swedish Orphan Biovitrum
Not Provided
Study Director: Keith Bragman, MD FRCP FRCPath FFPM Swedish Orphan Biovitrum
Swedish Orphan Biovitrum
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP