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

Primary Purpose

Diabetic Neuropathic Pain

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

BVT.115959

Placebo

About this trial

This is an interventional treatment trial for Diabetic Neuropathic Pain focused on measuring Diabetic neuropathy, painful, Adenosine A2A receptor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BVT.115959

Placebo

Arm Description

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

Placebo capsules administered orally three times daily

Outcomes

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

Full Information

NCT ID

NCT00452777

First Posted

March 26, 2007

Last Updated

October 31, 2014

Sponsor

Swedish Orphan Biovitrum

1. Study Identification

Unique Protocol Identification Number

NCT00452777

Brief Title

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

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

May 2007 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Swedish Orphan Biovitrum

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Neuropathic Pain

Keywords

Diabetic neuropathy, painful, Adenosine A2A receptor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

193 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BVT.115959

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo capsules administered orally three times daily

Intervention Type

Drug

Intervention Name(s)

BVT.115959

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Present pain intensity using an 11-point Likert NRS assessed at bedtime

Title

Short-Form McGill Pain Questionnaire parameters

Title

Weekly mean sleep interference score

Title

Clinical Global Impression of Change and Patient's Global Impression of Change

Title

Quality of life

Title

Mood stability

Title

Time to study withdrawal

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Keith Bragman, MD FRCP FRCPath FFPM

Organizational Affiliation

Swedish Orphan Biovitrum

Official's Role

Study Director

Facility Information:

Facility Name

Biovitrum investigational site

City

Ceske Budejovice

Country

Czech Republic

Facility Name

Biovitrum investigational site

City

Litomerice

Country

Czech Republic

Facility Name

Biovitrum investigational site

City

Plzen

Country

Czech Republic

Facility Name

Biovitrum investigational site

City

Praha 4

Country

Czech Republic

Facility Name

Biovitrum investigational site

City

Praha 8

Country

Czech Republic

Facility Name