Neuropathic PainPhase 2NCT01201317
A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Painful Diabetic Polyneuropathy
A Phase 2 study testing AZD2423 in people with Neuropathic Pain, run by AstraZeneca at 20 sites in 2 countries.
Trial summary
A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days treatment in patients with painful diabetic polyneuropathy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neuropathic 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
- 134 participants
- Where
- 20 sitesin 2 countries
- Study dates
- Sep 2010to Jun 2011
- 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 of non-child bearing potential patients aged 18 to 80 years
- Patients with neuropathic pain due to painful diabetic polyneuropathy.
Who cannot join
- Other pain that may confound assessment of neuropathic pain
- History of treatment failure with more than three adequate trials of medication for neuropathic pain
- Central neuropathic pain conditions (caused by Central Nervous System injury/disease, eg. Stroke)
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
United States14 sites
Research Site
DeLand, Florida
Research Site
Goodyear, Arizona
Research Site
Houston, Texas
Research Site
Los Angeles, California
Research Site
Madisonville, Kentucky
Research Site
Miami, Florida
Research Site
New York, New York
Research Site
Orlando, Florida
Research Site
Philadelphia, Pennsylvania
Research Site
Phoenix, Arizona
Research Site
Sunrise, Florida
Research Site
Tucson, Arizona
Research Site
Willingboro, New Jersey
Research Site
Winston-Salem, North Carolina
Canada6 sites
Research Site
Brampton, Ontario
Research Site
Etobicoke, Ontario
Research Site
Lachine, Quebec
Research Site
Laval
Research Site
Mississauga, Ontario
Research Site
Winnipeg, Manitoba
About this study
Official title: A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo
A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days treatment in patients with painful diabetic polyneuropathy.
- Conditions
- Neuropathic 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
150 mg tablet
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| AZD2423, 150 mg | Experimental | Tablets, 150 mg once daily in the morning. Receives: Drug: AZD2423 |
| AZD2423, 20 mg | Experimental | Tablets, 20 mg once daily in the morning. Receives: Drug: AZD2423 |
| Placebo | Placebo comparator | Tablets, placebo, once daily in the morning. 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) 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.
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 ≥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 Rating Scale (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 Scale (NPSI) Total Score.
Last Observation carried Forward (LOCF). Scale consists of 10 Neuropathic Pain Symptom Inventory Scale (NPSI) pain symptom descriptors wiht a recall period of 24 hours. Each descriptor is rated on a Numerical Rating Scale (NRS) 0-10; 0=No (symptom), 10=Worst (symptom) imaginable. The NPSI Total Score was calculated as the sum of 10 of the NPSI descriptors. Range for total score 0 -100. Higher total score implicates worse symptoms.
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.
- First posted14 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionJun 2011
- Study completionJun 2011
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
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bror Jonzon, Study director, AstraZeneca R&D Södertälje
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01201317
- Sponsor's protocol ID
- D2600C00005
- Status last verified
- Apr 2014
- First submitted
- 13 Sep 2010
- Last updated
- 25 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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
- ClinicalTrials.gov ID
- NCT01201317
- Acronym / sponsor ID
- D2600C00005
- Conditions
- Neuropathic Pain
- Keywords
- Analgesic effect
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 14 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 painful diabetic polyneuropathy.
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, 150 mg | Experimental | Drug: AZD2423Tablets, 150 mg once daily in the morning. |
| AZD2423, 20 mg | Experimental | Drug: AZD2423Tablets, 20 mg once daily in the morning. |
| Placebo | Placebo comparator | Drug: PlaceboTablets, placebo, once daily in the morning. |
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 of non-child bearing potential patients aged 18 to 80 years
- Patients with neuropathic pain due to painful diabetic polyneuropathy.
Key exclusion criteria (3 listed)
- Other pain that may confound assessment of neuropathic pain
- History of treatment failure with more than three adequate trials of medication 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, 20 mg |
| AZD2423150 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) 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 Rating Scale (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 Scale (NPSI) Total Score.
Time frame: Baseline (Day 1) to Day 29 (Visit 7)
Results and safety
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-D2600C00005.pdfLink provided by the sponsor.
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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 R&D Södertälje
20 sites in 2 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 Neuropathic Pain, run by AstraZeneca at 20 sites in 2 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 20 sites in United States, Canada. 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?
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.