Diabetic Neuropathic PainPhase 2NCT00452777
Efficacy and Tolerability of Novel A2A Agonist in Treatment of Diabetic Neuropathic Pain
A Phase 2 study testing BVT.115959 in people with Diabetic Neuropathic Pain, run by Swedish Orphan Biovitrum at 20 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Neuropathic Pain
- What is being tested?
- BVT.115959
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 193 participants
- Where
- 20 sitesin 3 countries
- Study dates
- May 2007to Jan 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
20 sites in 3 countries.
20 sites in 3 countries
Germany8 sites
Biovitrum Investigational Site
Bad Kreuznach
Biovitrum Investigational Site
Berlin
Biovitrum Investigational Site
Dortmund
Biovitrum Investigational Site
Gelsenkirchen
Biovitrum Investigational Site
Hamburg
Biovitrum Investigational Site
Mainz
Biovitrum Investigational Site
Mannheim
Biovitrum Investigational Site
Neumünster
South Africa8 sites
Biovitrum Investigational Site
Bloemfontein
Biovitrum Investigational Site
Durban
Biovitrum Investigational Site
Kenilworth
Biovitrum Investigational Site
Kraaifontein
Biovitrum Investigational Site
Polokwane
Biovitrum Investigational Site
Pretoria
Biovitrum Investigational Site
Somerset West
Biovitrum Investigational Site
Wynberg
Czechia4 sites
Biovitrum investigational site
České Budějovice
Biovitrum investigational site
Litoměřice
Biovitrum investigational site
Pilsen
Biovitrum investigational site
Prague
About this study
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
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.
Read the 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.
- Conditions
- Diabetic Neuropathic Pain
- Being tested
- BVT.115959, Placebo
- Keywords
- Diabetic neuropathy, painful, Adenosine A2A receptor
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BVT.115959Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BVT.115959 | Experimental | Capsules containing 7 mg BVT.115959 administered orally three times daily Receives: Drug: BVT.115959 |
| Placebo | Placebo comparator | Placebo capsules administered orally three times daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Mood stability
Time to study withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2007 (estimated)
- Study startMay 2007
- Primary completionDec 2007
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Swedish Orphan BiovitrumThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Orphan Biovitrum
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Keith Bragman, MD FRCP FRCPath FFPM, Study director, Swedish Orphan Biovitrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00452777
- Sponsor's protocol ID
- BVT.115959-005
- Status last verified
- Oct 2014
- First submitted
- 26 Mar 2007
- Last updated
- 3 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00452777
- Acronym / sponsor ID
- BVT.115959-005
- Conditions
- Diabetic Neuropathic Pain
- Keywords
- Diabetic neuropathy, painful, Adenosine A2A receptor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Swedish Orphan BiovitrumIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 27 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BVT.115959 | Experimental | Drug: BVT.115959Capsules containing 7 mg BVT.115959 administered orally three times daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsules administered orally three times daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BVT.115959 | Drug | BVT.115959 |
| Placebo | Drug | Placebo |
Primary outcome
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
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith Bragman, MD FRCP FRCPath FFPM study director
Swedish Orphan Biovitrum
20 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BVT.115959 in people with Diabetic Neuropathic Pain, run by Swedish Orphan Biovitrum at 20 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Germany, South Africa, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2014.