Nerve PainPhase 2NCT01200524

A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Posttraumatic Neuralgia..

A Phase 2 study testing AZD2423 in people with Nerve Pain, run by AstraZeneca at 25 sites in 7 countries.

Completed

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

Trial summary

A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days treatment in patients with posttraumatic neuralgia. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Nerve Pain
What is being tested?: AZD2423
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 133 participants
Where: 25 sitesin 7 countries
Study dates: Oct 2010to Apr 2012
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 signed informed consent form
Males and female patients aged 18 to 80 years
Patients with neuropathic pain due to peripheral nerve injury caused by trauma or surgery

Who cannot join

Other paint that may confound assessment of neuropathic pain
History of treatment failure with more than three adequate trials of treatment for neuropathic pain
Central neuropathic pain conditions (caused by Central Nervous System injury/disease, eg. Stroke)

Trial locations and contacts

25 sites in 7 countries.

Country

City, postcode or hospital

25 sites in 7 countries

Poland6 sites

Research Site
Gdansk
Research Site
Katowice
Research Site
Krakow
Research Site
Poznan
Research Site
Tychy
Research Site
Warsaw

Other trials in Poland

France4 sites

Research Site
Boulogne-Billancourt
Research Site
Clermont-Ferrand
Research Site
Nice
Research Site
Saint-Priest-en-Jarez

Other trials in France

Russia4 sites

Research Site
Kazan'
Research Site
Moscow
Research Site
Saint Petersburg
Research Site
Ufa

Other trials in Russia

United Kingdom4 sites

Research Site
Birmingham
Research Site
Bradford
Research Site
Glasgow
Research Site
Manchester

Other trials in United Kingdom

Sweden3 sites

Research Site
Falköping
Research Site
Kristianstad
Research Site
Stockholm

Other trials in Sweden

Bulgaria2 sites

Research Site
Pleven
Research Site
Sofia

Other trials in Bulgaria

Denmark2 sites

Research Site
Aalborg
Research Site
Odense

Other trials in Denmark

About this study

A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days treatment in patients with posttraumatic neuralgia.

Conditions: Nerve Pain
Being tested: AZD2423, Placebo
Keywords: Analgesic effect
Medical subject headings: Neuralgia

What participants receive

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

AZD2423Drug
20 mg tablet
AZD2423Drug
50 mg tablet
PlaceboDrug
Placebo

Study groups in NCT01200524
Study group	Role	What they receive
AZD2423, 20mg	Experimental	Not described Receives: Drug: AZD2423
AZD2423, 150 mg	Experimental	Not described Receives: Drug: AZD2423
Placebo	Placebo comparator	Tablet to match the 20 mg and 50 mg AZD2423 active tablet Receives: Drug: Placebo

What is being measured

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

Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score.
Last Observation Carried Forward (LOCF). Twice daily, the participants rated their Average Pain intensity during the past 12 hours on an Numerical Rating Scale (NRS) scale 0-10. 0= No pain, 10= Worst pain imaginable.
Measured: Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28

Secondary outcomes (4)

Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Worst Pain Score
Last Observation Carried Forward (LOCF). Twice daily, the participants rated their Worst Pain intensity during the past 12 hours on an Numerical Rating Scale (NRS) 0-10; 0=No pain, 10=Worst pain imaginable.
Measured: Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28
Number of Participants With at Least 30% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28.
LOCF- Last Observation Carried Forward. Numerical Rating Scale (NRS) Average Pain score reduction= (change from baseline at Day 28/baseline)*100. Responder=NRS Average Pain score reduction ≥30% (yes/no)
Measured: Baseline (mean of Day -5 to Day -1) to Day 28
Number of Participants With at Least 50% Decrease From Baseline in Numerical RatingScale (NRS) Average Pain Score at Day 28.
Last Observation Carried Forward (LOCF). Numerical Rating Scale (NRS) Average Pain score reduction=(change from baseline at Day 28/baseline)*100.
Responder= NRS Average Pain score reduction ≥50% (yes/no)
Measured: Baseline (mean of Day -5 to Day -1) to Day 28
Change From Baseline to Day 29 in Neuropathic Pain Symptom Inventory Scal (NPSI) Total Score.
LOCF- Last Observation Carried Forward. At baseline and at end of treatment the participants filled in their Neuropathic Pain Symptom Inventory Scal (NPSI) pain symptom descriptors, recall period 24 hours. Each descriptor was rated on a NUmerical Rating Scale 0-10; 0=No (symptom), 10=Worst (symptom) imaginable. The NPSI Total Score was calculated as the sum of 10 of the NPSI descriptors. Higher total score is considered worse outcome.
Measured: Baseline (Day 1) to Day 29 (Visit 7)

Timeline

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

Oct 2010Apr 2012

First posted13 Sep 2010 (estimated)
Study startOct 2010
Primary completionApr 2012
Study completionApr 2012

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 Nerve 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: 133 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01200524
Sponsor's protocol ID: D2600C00012
Status last verified: Apr 2014
First submitted: 10 Sep 2010
Last updated: 25 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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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All Nerve Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Posttraumatic Neuralgia..
ClinicalTrials.gov ID: NCT01200524
Acronym / sponsor ID: D2600C00012
Conditions: Nerve Pain
Keywords: Analgesic effect
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 133 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: Apr 2012 (actual)
Study completion: Apr 2012 (actual)
First posted: 13 Sep 2010 (estimated)
Results: Posted 25 Sep 2013

Clinical summary

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

A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days treatment in patients with posttraumatic neuralgia.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
AZD2423, 20mg	Experimental	Drug: AZD2423
AZD2423, 150 mg	Experimental	Drug: AZD2423
Placebo	Placebo comparator	Drug: PlaceboTablet to match the 20 mg and 50 mg AZD2423 active tablet

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 signed informed consent form
Males and female patients aged 18 to 80 years
Patients with neuropathic pain due to peripheral nerve injury caused by trauma or surgery

Key exclusion criteria (3 listed)

Other paint that may confound assessment of neuropathic pain
History of treatment failure with more than three adequate trials of treatment for neuropathic pain
Central neuropathic pain conditions (caused by Central Nervous System injury/disease, eg. Stroke)

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
AZD242320 mg tablet	Drug	AZD2423, 20mg
AZD242350 mg tablet	Drug	AZD2423, 150 mg
PlaceboPlacebo	Drug	Placebo

Primary outcome

Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score.
Time frame: Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28
Last Observation Carried Forward (LOCF). Twice daily, the participants rated their Average Pain intensity during the past 12 hours on an Numerical Rating Scale (NRS) scale 0-10. 0= No pain, 10= Worst pain imaginable.

4 secondary outcomes

Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Worst Pain Score
Time frame: Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28
Number of Participants With at Least 30% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28.
Time frame: Baseline (mean of Day -5 to Day -1) to Day 28
Number of Participants With at Least 50% Decrease From Baseline in Numerical RatingScale (NRS) Average Pain Score at Day 28.
Time frame: Baseline (mean of Day -5 to Day -1) to Day 28
Change From Baseline to Day 29 in Neuropathic Pain Symptom Inventory Scal (NPSI) Total Score.
Time frame: Baseline (Day 1) to Day 29 (Visit 7)

Results and safety

Results posted to the registry on 25 Sep 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AZD2423, 150 mg	41	39
AZD2423, 20mg	48	47
Placebo	44	40

Primary outcome: Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score.

Time frame: Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28. Mean (Standard Deviation). Unit: Scores on a scale

Measure	AZD2423, 150 mg n = 41	AZD2423, 20mg n = 47	Placebo n = 43
Value	-1.53 (1.67)	-1.54 (1.50)	-1.44 (1.59)

Population analysed: mITT analysis set including only those that had adequate NRS data at baseline and Days 24-28

4 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
AZD2423, 150 mg	0 of 41 (0%)	14 of 41 (34.1%)	Not reported
AZD2423, 20mg	0 of 48 (0%)	14 of 48 (29.2%)	Not reported
Placebo	0 of 44 (0%)	10 of 44 (22.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
CSR-D2600C00012.pdfLink provided by the sponsor.

Related trials for Nerve Pain

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Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
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RecruitingObservational study
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
Amputation, Amputation of Lower Limb
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
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Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
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Not yet recruiting
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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.

Bror Jonzon study director

AstraZeneca

25 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD2423 in people with Nerve Pain, run by AstraZeneca at 25 sites in 7 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 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 25 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Poland, France, Russia, United Kingdom, Sweden and 2 more countries. 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 25 Sep 2013). 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 From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score. (time frame: Baseline (mean of Day -5 to Day -1) to the mean of Day 24 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 NCT01200524.

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 25 Apr 2014.