Clinical trial NCT00452777: Efficacy and Tolerability of Novel A2A Agonist in Treatment of Diabetic Neuropathic Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Neuropathic Pain
Keywords: Diabetic neuropathy, painful
Adenosine A2A receptor
Lead sponsor: Swedish Orphan Biovitrum
Sponsor class: INDUSTRY
First posted: 2007-03-27
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
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 outcomes:
measure: Present pain intensity using an 11-point Likert NRS assessed at bedtime
measure: Short-Form McGill Pain Questionnaire parameters
measure: Weekly mean sleep interference score
measure: Clinical Global Impression of Change and Patient's Global Impression of Change
measure: Quality of life
measure: Mood stability
measure: Time to study withdrawal
Other outcomes:
Locations:
city: Ceske Budejovice
country: Czech Republic
facility: Biovitrum investigational site
city: Litomerice
country: Czech Republic
facility: Biovitrum investigational site
city: Plzen
country: Czech Republic
facility: Biovitrum investigational site
city: Praha 4
country: Czech Republic
facility: Biovitrum investigational site
city: Praha 8
country: Czech Republic
facility: Biovitrum investigational site
city: Bad Kreuznach
country: Germany
facility: Biovitrum Investigational Site
city: Berlin
country: Germany
facility: Biovitrum Investigational Site
city: Dortmund
country: Germany
facility: Biovitrum Investigational Site
city: Gelsenkirchen
country: Germany
facility: Biovitrum Investigational Site
city: Hamburg
country: Germany
facility: Biovitrum Investigational Site
city: Mainz
country: Germany
facility: Biovitrum Investigational Site
city: Mannheim
country: Germany
facility: Biovitrum Investigational Site
city: Neumunster
country: Germany
facility: Biovitrum Investigational Site
city: Bloemfontein
country: South Africa
facility: Biovitrum Investigational Site
city: Durban
country: South Africa
facility: Biovitrum Investigational Site
city: Kenilworth
country: South Africa
facility: Biovitrum Investigational Site
city: Kraaifontein
country: South Africa
facility: Biovitrum Investigational Site
city: Polokwane
country: South Africa
facility: Biovitrum Investigational Site
city: Pretoria
country: South Africa
facility: Biovitrum Investigational Site
city: Somerset West
country: South Africa
facility: Biovitrum Investigational Site
city: Wynberg
country: South Africa
facility: Biovitrum Investigational Site
Study officials:
affiliation: Swedish Orphan Biovitrum
name: Keith Bragman, MD FRCP FRCPath FFPM
role: STUDY_DIRECTOR
References: