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

NCT ID: NCT00452777

Last Updated: 2014-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

193 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetic Neuropathic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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BVT.115959

Capsules containing 7 mg BVT.115959 administered orally three times daily

Group Type EXPERIMENTAL

BVT.115959

Intervention Type DRUG

Placebo

Placebo capsules administered orally three times daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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BVT.115959

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swedish Orphan Biovitrum

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Keith Bragman, MD FRCP FRCPath FFPM

Role: STUDY_DIRECTOR

Swedish Orphan Biovitrum

Locations

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Biovitrum investigational site

České Budějovice, , Czechia

Site Status

Biovitrum investigational site

Litoměřice, , Czechia

Site Status

Biovitrum investigational site

Pilsen, , Czechia

Site Status

Biovitrum investigational site

Prague, , Czechia

Site Status

Biovitrum Investigational Site

Bad Kreuznach, , Germany

Site Status

Biovitrum Investigational Site

Berlin, , Germany

Site Status

Biovitrum Investigational Site

Dortmund, , Germany

Site Status

Biovitrum Investigational Site

Gelsenkirchen, , Germany

Site Status

Biovitrum Investigational Site

Hamburg, , Germany

Site Status

Biovitrum Investigational Site

Mainz, , Germany

Site Status

Biovitrum Investigational Site

Mannheim, , Germany

Site Status

Biovitrum Investigational Site

Neumünster, , Germany

Site Status

Biovitrum Investigational Site

Bloemfontein, , South Africa

Site Status

Biovitrum Investigational Site

Durban, , South Africa

Site Status

Biovitrum Investigational Site

Kenilworth, , South Africa

Site Status

Biovitrum Investigational Site

Kraaifontein, , South Africa

Site Status

Biovitrum Investigational Site

Polokwane, , South Africa

Site Status

Biovitrum Investigational Site

Pretoria, , South Africa

Site Status

Biovitrum Investigational Site

Somerset West, , South Africa

Site Status

Biovitrum Investigational Site

Wynberg, , South Africa

Site Status

Countries

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Czechia Germany South Africa

Other Identifiers

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BVT.115959-005

Identifier Type: -

Identifier Source: org_study_id

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