PainPhase 2NCT00857623

Study to Evaluate the Analgesic Efficacy of 28 Days' Oral Administration of AZD2066 Compared With Placebo in Patients With Painful Diabetic Neuropathy

A Phase 2 study testing AZD2066 in people with Pain and Diabetic Neuropathy, run by AstraZeneca at 19 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to investigate if AZD2066 can relieve the pain arising from painful diabetic neuropathy compared to placebo. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Pain, Diabetic Neuropathy
What is being tested?: AZD2066
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 127 participants
Where: 19 sitesUnited States
Study dates: Feb 2009to Aug 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Provision of informed consent prior to any study specific procedures.
Clinical diagnosis of painful diabetic neuropathy.
non-fertile females

Who cannot join

Other pain that may confound assessment of neuropathic pain.
Ongoing significant peripheral arterial diseases, skin ulcers, or amputation in the lower extremities.
History of psychotic disorders among first degree relatives.

Trial locations and contacts

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

United States19 sites

Reasearch Site
Albany, New York
Reserach Site
Bella Vista, Arkansas
Research Site
Bingham Farms, Michigan
Research Site
Clearwater, Florida
Research Site
DeLand, Florida
Research Site
Houston, Texas
Research Site
Indiana, Pennsylvania
Research Site
Lauderdale Lakes, Florida
Research Site
Madisonville, Kentucky
Research Site
Miami, Florida
Research Site
National City, California
Research Site
Orlando, Florida
Research Site
Owing Mills, Maryland
Research Site
Pembroke Pines, Florida
Research Site
Philadelphia, Pennsylvania
Research Site
San Antonio, Texas
Research Site
Walnut Creek, California
Research Site
Willingboro, New Jersey
Research Site
Winston-Salem, North Carolina

Other trials in United States

About this study

Official title: A Phase IIa, Double-Blind, Randomised, Parallel-Group, Multi-Centre Study to Evaluate the Analgesic Efficacy of 28 Days' Oral Administration of AZD2066 Compared With Placebo in Patients With Painful Diabetic Neuropathy

The purpose of this study is to investigate if AZD2066 can relieve the pain arising from painful diabetic neuropathy compared to placebo.

Conditions: Pain, Diabetic Neuropathy
Being tested: AZD2066, Placebo
Keywords: Pain, Diabetic Neuropathy, PDN, Analgesia, Efficacy
Medical subject headings: Pain, Diabetic Neuropathies, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZD2066Drug
Capsule, once daily, 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28.
PlaceboDrug
Capsule, once daily

Study groups in NCT00857623
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: AZD2066
2	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Mean Numerical Rating Scale (NRS) Score From Baseline to Last 5 Days of Treatment
Change of mean pain intensity from 5-day baseline to the last 5 days of treatment, measured twice daily with NRS (12 hours recall).
Mean pain intensity for 5-day baseline period (evening Day -6 to moning Day-1) and mean pain intensity for last 5 days on treatment (ie, last dose day and the 4 preceding calendar days) was calculated based on the numerical rating scale (NRS)(0-10). 0=No pain, 10=Worst pain imaginable.
Measured: From baseline to day 28

Secondary outcomes (8)

Daily Numerical Rating Scale (NRS) Pain Scores and Change From Baseline Over Time to Day 28.
Mean pain intensity per day (mean of morning and evening NRS values) and change from baseline were calculated for each study day. Baseline value= mean pain intensity for the 5-day baseline period. NRS scale (0- 10) where 0= No pain and 10= Worst pain imaginable.
Measured: From baseline to 28 days
Number of Patients With >=30% Reduction From Baseline in Numerical Rating Scale (NRS) Pain Intensity Score at Day 28
Pain intensity score reduction=(change from baseline at D28/baseline)*100 Responder= pain intensity score reduction ≥30% (yes/no)? Responder rate= (no. of responders/total no. of patients)*100
Measured: 28 days
Number of Patients With >=50% Reduction From Baseline in Numerical Rating Scale (NRS) Pain Intensity Score at Day 28
Pain intensity score reduction= (change from baseline D28/baseline)*100 Responder=pain intensity score reduction ≥50% (Yes/No)? Responder rate= (no. of responders/total no. of patients)*100
Measured: 28 days
Number of Patients With Patient Global Impression of Change (PGIC) Score of at Least "Much Improved" at Day 28.
Patient Global Impression of Change (PGIC) scale ranges from 1-7, where 1= Very much improved and 7= Very much worse.
Responder= Patient with a response of "much improved" or "very much improved" Responder rate= (no. of responders/total no. of patients)*100
Measured: 28 days
Change in McGill Pain Questionnaire Short Form (MPQ-SF) Sensory Index From Baseline to Day 28.
Sensory index= sum of the intensity scale values of the words chosen for the descriptors 1-11 in the questionnaire. Range of scores for the sensory index= 0-33 (higher score represents a worse condition).
Change from baseline (measured prior to randomization) to Day 28 was calculated.
Measured: From baseline to day 28.
Change in McGill Pain Questionnaire Short Form (MPQ-SF) Affective Index From Baseline to Day 28.
Affective index= sum of the intensity scale values of the words chosen for the descriptors 12-15 in the questionnaire. Range of scores for the affective index=0-12 (higher score represents a worse condition).
Change from baseline (measured prior to randomization) to Day 28 was calculated.
Measured: From baseline to day 28.
Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Severity From Baseline to Day 28.
Change from baseline (measured prior to randomization) to Day 28 was calculated for the pain severity (mean of 4 intensity items). Each intensity item is recorded on a Numerical rating Scale (NRS) 0-10, where 0=No pain and 10= The worst pain.
Measured: From baseline to day 28..
Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Interference From Baseline to Day 28.
Change from baseline (measured prior to randomization) to Day 28 was calculated for pain interference (mean of 7 interference items). Each interference item is recorded on a Numerical Rating Scale (NRS 0-10), where 0= No interference and 10= Interferes completely.
Measured: From baseline to 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2009Aug 2009

First posted6 Mar 2009 (estimated)
Study startFeb 2009
Primary completionAug 2009
Study completionAug 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PainStudies of the same condition, open and under way.
More trials run by AstraZenecaThe 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 127 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00857623
Sponsor's protocol ID: D0475C00009
Status last verified: Nov 2012
First submitted: 27 Feb 2009
Last updated: 12 Nov 2012
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIa, Double-Blind, Randomised, Parallel-Group, Multi-Centre Study to Evaluate the Analgesic Efficacy of 28 Days' Oral Administration of AZD2066 Compared With Placebo in Patients With Painful Diabetic Neuropathy
ClinicalTrials.gov ID: NCT00857623
Acronym / sponsor ID: D0475C00009
Conditions: Pain, Diabetic Neuropathy
Keywords: Pain, Diabetic Neuropathy, PDN, Analgesia, Efficacy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 127 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Feb 2009
Primary completion: Aug 2009 (actual)
Study completion: Aug 2009 (actual)
First posted: 6 Mar 2009 (estimated)
Results: Posted 29 Oct 2012

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 investigate if AZD2066 can relieve the pain arising from painful diabetic neuropathy compared to placebo.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: AZD2066
2	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Provision of informed consent prior to any study specific procedures.
Clinical diagnosis of painful diabetic neuropathy.
non-fertile females

Key exclusion criteria (3 listed)

Other pain that may confound assessment of neuropathic pain.
Ongoing significant peripheral arterial diseases, skin ulcers, or amputation in the lower extremities.
History of psychotic disorders among first degree relatives.

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
AZD2066Capsule, once daily, 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28.	Drug	1
PlaceboCapsule, once daily	Drug	2

Primary outcome

Change in Mean Numerical Rating Scale (NRS) Score From Baseline to Last 5 Days of Treatment
Time frame: From baseline to day 28
Change of mean pain intensity from 5-day baseline to the last 5 days of treatment, measured twice daily with NRS (12 hours recall). Mean pain intensity for 5-day baseline period (evening Day -6 to moning Day-1) and mean pain intensity for last 5 days on treatment (ie, last dose day and the 4 preceding calendar days) was calculated based on the numerical rating scale (NRS)(0-10). 0=No pain, 10=Worst pain imaginable.

8 secondary outcomes

Daily Numerical Rating Scale (NRS) Pain Scores and Change From Baseline Over Time to Day 28.
Time frame: From baseline to 28 days
Number of Patients With >=30% Reduction From Baseline in Numerical Rating Scale (NRS) Pain Intensity Score at Day 28
Time frame: 28 days
Number of Patients With >=50% Reduction From Baseline in Numerical Rating Scale (NRS) Pain Intensity Score at Day 28
Time frame: 28 days
Number of Patients With Patient Global Impression of Change (PGIC) Score of at Least "Much Improved" at Day 28.
Time frame: 28 days
Change in McGill Pain Questionnaire Short Form (MPQ-SF) Sensory Index From Baseline to Day 28.
Time frame: From baseline to day 28.
Change in McGill Pain Questionnaire Short Form (MPQ-SF) Affective Index From Baseline to Day 28.
Time frame: From baseline to day 28.
Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Severity From Baseline to Day 28.
Time frame: From baseline to day 28..
Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Interference From Baseline to Day 28.
Time frame: From baseline to 28 days

Results and safety

Results posted to the registry on 29 Oct 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AZD2066	62	48
Placebo	65	55

Primary outcome: Change in Mean Numerical Rating Scale (NRS) Score From Baseline to Last 5 Days of Treatment

Time frame: From baseline to day 28. Least squares mean (Standard Error). Unit: Scores on a scale

Measure	AZD2066 n = 46	Placebo n = 51
Value	-2.33 (0.37)	-2.52 (0.36)

Population analysed: Per Protocol population (PP)

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AZD2066	1 of 62 (1.6%)	19 of 62 (30.6%)	Not reported
Placebo	1 of 65 (1.5%)	20 of 65 (30.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Biljana Lilja study director

AstraZeneca R&D Södertälje151 85 Södertälje, Sweden

Charles E Argoff, MD principal investigator

Albany Medical , NY 12208, USA

19 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD2066 in people with Pain and Diabetic Neuropathy, run by AstraZeneca at 19 sites in United States.

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 3 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 12 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. 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?

Yes. Results are posted in the registry (first posted 29 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Numerical Rating Scale (NRS) Score From Baseline to Last 5 Days of Treatment (time frame: From baseline to day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00857623.

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 12 Nov 2012.