Neuropathic PainPhase 2NP-MHNCT00939094

AZD2066 Neuropathic Pain - Mechanical Hypersensitivity

A Phase 2 study testing AZD2066 in people with Neuropathic Pain and Mechanical Hypersensitivity, run by AstraZeneca at 38 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to investigate if 28 days of treatment with AZD2066 compared to placebo can relieve the pain arising from the nervous system when the patients are touched by something that should not cause pain or have severe pain when they are touched by something that should only cause a little pain. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Neuropathic Pain, Mechanical Hypersensitivity
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: 87 participants
Where: 38 sitesUnited States
Study dates: Aug 2009to Nov 2010
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.
Male or non-fertile females
Painful symptoms due to neuropathic pain for a period of 3 months to 5 years, associated with mechanical allodynia and/or punctate hyperalgesia.

Who cannot join

Other pain that may confound assessment of neuropathic pain.
Diagnosis of any severe neurological disease.
History of significant psychiatric disease/condition and/or history of psychotic disorders among first degree relatives.

Trial locations and contacts

38 sites in 1 country.

City, postcode or hospital

38 sites in 1 country

United States38 sites

Research Site
Albuquerque, New Mexico
Research Site
Atlantis, Florida
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Austin, Texas
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Aventura, Florida
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Bingham Farms, Michigan
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Boulder, Colorado
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Bridgeville, Pennsylvania
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Brockton, Massachusetts
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Canton, Georgia
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Clearwater, Florida
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Dallas, Texas
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Evansville, Indiana
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Fort Myers, Florida
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Irving, Texas
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Jacksonville, North Carolina
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Kettering, Ohio
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Las Vegas, Nevada
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Lexington, Texas
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Longview, Texas
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Los Angeles, California
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Lumberton, New Jersey
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Marietta, Georgia
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New Orleans, Louisiana
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Orlando, Florida
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Palm Beach Gardens, Florida
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Philadelphia, Pennsylvania
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Portland, Oregon
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Reno, Nevada
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Sacramento, California
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San Antonio, Texas
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San Francisco, California
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Sarasota, Florida
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St. Petersburg, Florida
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Sunrise, Florida
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Tucson, Arizona
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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 to Placebo in Peripheral Neuropathic Pain Patients With Mechanical Hypersensitivity

Conditions: Neuropathic Pain, Mechanical Hypersensitivity
Being tested: AZD2066, Placebo
Keywords: Pain, Mechanical Hypersensitivity, Allodynia, Efficacy, analgesia, Neuropathic
Medical subject headings: Neuralgia, Pain, Hyperalgesia, Agnosia

What participants receive

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

AZD2066Drug
Capsule, once daily
PlaceboDrug
Capsule, once daily

Study groups in NCT00939094
Study group	Role	What they receive
A	Experimental	Not described Receives: Drug: AZD2066
B	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) Pain Score From Baseline to Last 5 Days on Treatment
Mean pain intensity for 5-day baseline period (morning Day -5 to evening 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 NRS scale (0-10). 0=No pain, 10=Worst pain imaginable.
Measured: Change in mean pain intensity from 5-day baseline to the last 5 days on treatment, measure twice daily with NRS (12-hour recall)

Secondary outcomes (7)

Patients With ≥30% Reduction From Baseline in NRS Pain Intensity Score (Responder Rate) at Day 28
NRS pain intensity score reduction=(change from baseline at Day 28/baseline)*100 Responder=pain intensity score reduction ≥30% (yes/no)? Responder rate=(no. of responders/total no. of patients)*100
Measured: 28 days
Patients With ≥50% Reduction From Baseline in NRS Pain Intensity Score (Responder Rate) at Day 28
Pain intensity score reduction=(change from baseline Day 28/baseline)*100 Responder=pain intensity score reduction ≥50% (Yes/No)? Responder rate=(no. of responders/total no. of patients)*100
Measured: 28 days
Patients With Patient Global Impression of Change (PGIC) Score of at Least "Much Improved" (Responder Rate) at Day 28
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 Short Form McGill Pain Questionnaire (SF-MPQ) 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: 28 days
Change in SF-MPQ 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: 28 days
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 NRS 0-10, where 0=No Pain and 10=Pain as bad as you can imagine.
Measured: 28 days
Change in 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 NRS 0-10, where 0=No interference and 10=Interferes completely.
Measured: 28 days

Timeline

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

Aug 2009Nov 2010

First posted14 Jul 2009 (estimated)
Study startAug 2009
Primary completionNov 2010
Study completionNov 2010

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 Neuropathic 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: 87 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00939094
Sponsor's protocol ID: D0475C00016
Acronym: NP-MH
Status last verified: Aug 2012
First submitted: 13 Jul 2009
Last updated: 27 Sep 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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Sep 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 to Placebo in Peripheral Neuropathic Pain Patients With Mechanical Hypersensitivity
ClinicalTrials.gov ID: NCT00939094
Acronym / sponsor ID: NP-MH / D0475C00016
Conditions: Neuropathic Pain, Mechanical Hypersensitivity
Keywords: Pain, Mechanical Hypersensitivity, Allodynia, Efficacy, analgesia, Neuropathic
Phase: Phase 2
Study type: Interventional
Recruitment status: Terminated
Enrolment: 87 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Quintiles, Inc.
Study start: Aug 2009
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 14 Jul 2009 (estimated)
Results: Posted 27 Sep 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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
A	Experimental	Drug: AZD2066
B	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.
Male or non-fertile females
Painful symptoms due to neuropathic pain for a period of 3 months to 5 years, associated with mechanical allodynia and/or punctate hyperalgesia.

Key exclusion criteria (3 listed)

Other pain that may confound assessment of neuropathic pain.
Diagnosis of any severe neurological disease.
History of significant psychiatric disease/condition and/or 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	Drug	A
PlaceboCapsule, once daily	Drug	B

Primary outcome

Change in Mean Numerical Rating Scale (NRS) Pain Score From Baseline to Last 5 Days on Treatment
Time frame: Change in mean pain intensity from 5-day baseline to the last 5 days on treatment, measure twice daily with NRS (12-hour recall)
Mean pain intensity for 5-day baseline period (morning Day -5 to evening 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 NRS scale (0-10). 0=No pain, 10=Worst pain imaginable.

7 secondary outcomes

Patients With ≥30% Reduction From Baseline in NRS Pain Intensity Score (Responder Rate) at Day 28
Time frame: 28 days
Patients With ≥50% Reduction From Baseline in NRS Pain Intensity Score (Responder Rate) at Day 28
Time frame: 28 days
Patients With Patient Global Impression of Change (PGIC) Score of at Least "Much Improved" (Responder Rate) at Day 28
Time frame: 28 days
Change in Short Form McGill Pain Questionnaire (SF-MPQ) Sensory Index From Baseline to Day 28
Time frame: 28 days
Change in SF-MPQ Affective Index From Baseline to Day 28
Time frame: 28 days
Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Severity From Baseline to Day 28
Time frame: 28 days
Change in BPI-SF Pain Interference From Baseline to Day 28
Time frame: 28 days

Results and safety

Results posted to the registry on 27 Sep 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
A - AZD2066	42	28
2 - Placebo	45	35

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

Time frame: Change in mean pain intensity from 5-day baseline to the last 5 days on treatment, measure twice daily with NRS (12-hour recall). Least squares mean (Standard Error). Unit: Scores (units) on NRS

Measure	A - AZD2066 n = 30	2 - Placebo n = 38
Value	-2.14 (0.358)	-1.26 (0.337)

7 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
A - AZD2066	1 of 42 (2.4%)	30 of 42 (71.4%)	Not reported
2 - Placebo	0 of 44 (0%)	15 of 44 (34.1%)	Not reported

Limitations and caveats (from the sponsor): Early termination of study for safety reasons leading to fewer subjects analyzed than originally planned.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 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

Brett Stacey principal investigator

Oregon Health and Science University Comprehensive Pain Clinic, Portland, OR 97239, USA

38 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 Neuropathic Pain and Mechanical Hypersensitivity, run by AstraZeneca at 38 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: stopped early, as of the sponsor's last update on 27 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 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 27 Sep 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) Pain Score From Baseline to Last 5 Days on Treatment (time frame: Change in mean pain intensity from 5-day baseline to the last 5 days on treatment, measure twice daily with NRS (12-hour recall)). 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 NCT00939094.

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 27 Sep 2012.