PainPhase 2AVANTNCT00976534
Study to Evaluate Efficacy, Safety, Tolerability and Pharmacokinetics of AZD1386 in Patients With Peripheral Neuropathic Pain
A Phase 2 study testing AZD1386 in people with Pain and Neuropathic Pain, run by AstraZeneca at 12 sites in 4 countries.
Trial summary
The primary aim of this study is to investigate if AZD1386 is efficacious as an analgesic in patients with peripheral neuropathic pain. This will be done by comparing the effect of AZD1386 to placebo ("inactive substance") on pain. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Neuropathic Pain
- What is being tested?
- AZD1386
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 12 sitesin 4 countries
- Study dates
- Sep 2009to Feb 2010
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with painful symptoms due to neuropathic pain
- Provision of signed informed consent
- Non pregnant females
Who cannot join
- Other pain conditions that may confound assessment of neuropathic pain, as judged by the investigator
- History, and/or presence of somatic disease, which may interfere with the objectives of the study as judged by the investigator
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
United Kingdom4 sites
Research Site
Bradford
Research Site
Glasgow
Research Site
London
Research Site
Manchester
Canada3 sites
Research Site
Calgary, Alberta
Research Site
Halifax, Nova Scotia
Research Site
Toronto, Ontario
France3 sites
Research Site
Boulogne-Billancourt
Research Site
Clermont-Ferrand
Research Site
Nice
About this study
Official title: A Phase IIa Randomised, Double-blind, Placebo Controlled, Parallel Group, Multicentre Study Evaluating the Efficacy, Safety, Tolerability and Pharmacokinetics of AZD1386 After 3 Weeks of Treatment in Patients With Posttraumatic Neuralgia (PTN) and Postherpetic Neuralgia (PHN)
The primary aim of this study is to investigate if AZD1386 is efficacious as an analgesic in patients with peripheral neuropathic pain. This will be done by comparing the effect of AZD1386 to placebo ("inactive substance") on pain.
- Conditions
- Pain, Neuropathic Pain
- Being tested
- AZD1386, Placebo
- Keywords
- Analgesic effect, Peripheral Neuropathic pain, Posttraumatic Neuralgia (PTN), Postherpetic Neuralgia (PHN)
- Medical subject headings
- Pain, Neuralgia, Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1386Drug
90 mg, capsules, oral, during 3 weeks
PlaceboDrug
capsules, oral, during 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: AZD1386 |
| 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 from baseline in NRS pain (12 h-recall)
Measured: Morning and evening 12 hour recall
Secondary outcomes (3)
Response rate, defined as any of the following:NRS (12 h recall) reduced by 30% compared to baseline and NRS (12 h recall) reduced by 50% compared to baseline
Measured: Morning and evening 12 hour recall
Response rate, defined as any of the following: At least "much improved" on Patient Global Impression of Change global and at least "much improved" on PGIC pain
Measured: Day 8, 15 and 22
Response rate, defined as any of the following: Change from baseline in Brief Pain Inventory Short Form and Change from baseline in Pain Quality Assessment Scale
Measured: Day 1 and 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2009 (estimated)
- Study startSep 2009
- Study completionFeb 2010 (estimated)
Why it stopped: The study was terminated due to results in another study (NCT00878501).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Richard L Leff, md, Study director, AstraZeneca R&D Wilmington, USARolf Karlsten, MD, Study chair, AstraZeneca R&D Södertälje, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00976534
- Sponsor's protocol ID
- D5090C00018
- Acronym
- AVANT
- Status last verified
- Dec 2009
- First submitted
- 9 Sep 2009
- Last updated
- 23 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Randomised, Double-blind, Placebo Controlled, Parallel Group, Multicentre Study Evaluating the Efficacy, Safety, Tolerability and Pharmacokinetics of AZD1386 After 3 Weeks of Treatment in Patients With Posttraumatic Neuralgia (PTN) and Postherpetic Neuralgia (PHN)
- ClinicalTrials.gov ID
- NCT00976534
- Acronym / sponsor ID
- AVANT / D5090C00018
- Conditions
- Pain, Neuropathic Pain
- Keywords
- Analgesic effect, Peripheral Neuropathic pain, Posttraumatic Neuralgia (PTN), Postherpetic Neuralgia (PHN)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to results in another study (NCT00878501).
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Study completion
- Feb 2010 (estimated)
- First posted
- 14 Sep 2009 (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 primary aim of this study is to investigate if AZD1386 is efficacious as an analgesic in patients with peripheral neuropathic pain. This will be done by comparing the effect of AZD1386 to placebo ("inactive substance") on pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD1386 |
| 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)
- Patients with painful symptoms due to neuropathic pain
- Provision of signed informed consent
- Non pregnant females
Key exclusion criteria (2 listed)
- Other pain conditions that may confound assessment of neuropathic pain, as judged by the investigator
- History, and/or presence of somatic disease, which may interfere with the objectives of the study as judged by the investigator
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 |
|---|---|---|
| AZD138690 mg, capsules, oral, during 3 weeks | Drug | 1 |
| Placebocapsules, oral, during 3 weeks | Drug | 2 |
Primary outcome
Change from baseline in NRS pain (12 h-recall)
Time frame: Morning and evening 12 hour recall
3 secondary outcomes
Response rate, defined as any of the following:NRS (12 h recall) reduced by 30% compared to baseline and NRS (12 h recall) reduced by 50% compared to baseline
Time frame: Morning and evening 12 hour recall
Response rate, defined as any of the following: At least "much improved" on Patient Global Impression of Change global and at least "much improved" on PGIC pain
Time frame: Day 8, 15 and 22
Response rate, defined as any of the following: Change from baseline in Brief Pain Inventory Short Form and Change from baseline in Pain Quality Assessment Scale
Time frame: Day 1 and 22
Results and safety
The study was stopped early (reason given: The study was terminated due to results in another study (NCT00878501).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2009.
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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.
Richard L Leff, md study director
AstraZeneca R&D Wilmington, USA
Rolf Karlsten, MD study chair
AstraZeneca R&D Södertälje, Sweden
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD1386 in people with Pain and Neuropathic Pain, run by AstraZeneca at 12 sites in 4 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 2 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 23 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United Kingdom, Canada, France, Denmark. 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 was stopped early (reason given: The study was terminated due to results in another study (NCT00878501).). Results are not available in the source record.
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 in NRS pain (12 h-recall) (time frame: Morning and evening 12 hour recall). 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 23 Dec 2009.