NCT00452777|CompletedPhase 2DMC

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

Swedish Orphan Biovitrum ClinicalTrials.gov

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1 other identifier

BVT.115959-005

Study Type

interventional

Target

193

Locations

3 countries

Sites

Timeline

RegisteredMar 2007

StartedMay 2007

CompletionJan 2008

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

193

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started May 2007

Shorter than P25 for phase_2

Geographic Reach

3 countries

20 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

8 months study duration

First Submitted

Initial submission to the registry

March 26, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

March 27, 2007

Completed

1 month until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed

7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed

Last Updated

November 3, 2014

Status Verified

October 1, 2014

Enrollment Period

7 months

First QC Date

March 26, 2007

Last Update Submit

October 31, 2014

Conditions

Diabetic Neuropathic Pain

Keywords

Diabetic neuropathy, painfulAdenosine A2A receptor

Outcome Measures

Primary Outcomes (1)

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 (7)

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
+2 more secondary outcomes

Study Arms (2)

BVT.115959

EXPERIMENTAL

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

Drug: BVT.115959

Placebo

PLACEBO COMPARATOR

Placebo capsules administered orally three times daily

Drug: Placebo

Interventions

BVT.115959DRUG

BVT.115959

PlaceboDRUG

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Swedish Orphan Biovitrumlead

Study Sites (20)

Biovitrum investigational site

České Budějovice, Czechia

Location

Biovitrum investigational site

Litoměřice, Czechia

Location

Biovitrum investigational site

Pilsen, Czechia

Location

Biovitrum investigational site

Prague, Czechia

Location