Capsaicin Evoked PainPhase 1NCT00692146
Study to Investigate the Effects Single Oral Dose of AZD1386 (Capsaicin)
A Phase 1 study testing AZD1386 in people with Capsaicin Evoked Pain and Heat Sensitivity, run by AstraZeneca.
Trial summary
A double-blind, randomized, single-centre, placebo-controlled, crossover study to investigate the effects of a single oral dose of AZD1386 on intradermal capsaicin evoked pain symptoms and heat sensitivity in healthy volunteers Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Capsaicin Evoked Pain, Heat Sensitivity
- 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
- 36 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to May 2008
- Phase
- Phase 1
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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinical normal physical findings, including BP, pulse rate >45 bpm, ECG and laboratory assessments
- Body Mass Index (BMI) of ≥18 to ≤30 kg/m2 and weight of ≥50 to ≤100 kg.
- Non-fertile females
Who cannot join
- History of hypersensitivity, allergy or atopic/skin disease as judged by Investigator.
- History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study as judged by the Investigator.
About this study
Official title: A Double-Blind, Randomized, Single-Centre, Placebo-Controlled, Crossover Study to Investigate the Effects of a Single Oral Dose of AZD1386 on Intradermal Capsaicin Evoked Pain Symptoms and Heat Sensitivity in Healthy Volunteers
A double-blind, randomized, single-centre, placebo-controlled, crossover study to investigate the effects of a single oral dose of AZD1386 on intradermal capsaicin evoked pain symptoms and heat sensitivity in healthy volunteers
- Conditions
- Capsaicin Evoked Pain, Heat Sensitivity
- Being tested
- AZD1386, Placebo
- Keywords
- Proof of Mechanism, Capsaicin evoked pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1386Drug
Oral solution fixed dose (95 mg given orally on two occasions)
PlaceboDrug
Oral solution fixed dose (95 mg given orally on two occasions)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 36 subjects receiving a specified volume of the active component AZD1386 in a single dose. Receives: Drug: AZD1386 |
| 2 | Placebo comparator | 36 subjects receiving a specified volume of placebo in a single dose. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS, HPT
Measured: Visit 2-4
Secondary outcomes (3)
eVAS, HPT, Laser Doppler imaging,WDT, Somedic allodynia
Measured: Visit 2-4
Vital signs, laboratory variables and adverse event each day throughout the study. paper printout ECG and/or digital ECG throughout the study. Pain evoked assessments visit 1-3
Measured: Visit 1-5
Pharmacokinetics/Pharmacodynamics
Measured: Visit 2-4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startJan 2008
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Capsaicin Evoked 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Agneta Berg, Study chair, AstraZeneca R&D SödertäljeIngemar Bylesjö, Principal investigator, AstraZeneca R&D CPU Karolinska University Hospital, Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00692146
- Sponsor's protocol ID
- D5090C00009
- Status last verified
- Jun 2008
- First submitted
- 5 Jun 2008
- Last updated
- 6 Jun 2008
- Results posted
- No
- Data monitoring committee
- No