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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00689780 |
A Phase I, Multi-Centre, Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1940, Including an Interaction Study, After Administration of Oral Multiple Ascending Doses in Adult Subjects with Chronic Low Back Pain
Condition | Intervention | Phase |
---|---|---|
Low Back Pain |
Drug: AZD1940 Drug: Midazolam |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study |
Official Title: | A Phase I, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1940, Including an Interaction Study, After Administration of Oral Multiple Ascending Doses in Adult Subjects With Chronic Low Back Pain |
Estimated Enrollment: | 60 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
AZD1940 + Placebo
|
Drug: AZD1940
Oral solution Multiple ascending dose given orally once daily at day 1-12
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2 |
Drug: Midazolam
Oral solution given orally once daily on day -1 and day 14
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Ages Eligible for Study: | 20 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: AstraZeneca Clinical Study Information | 800-236-9933 | information.center@astrazeneca.com |
Sweden | |
Research Site | Recruiting |
Linkoping, Sweden | |
Research Site | Recruiting |
Lulea, Sweden | |
Research Site | Recruiting |
Upssala, Sweden |
Study Chair: | Janet Post | AstraZeneca R&D SödertäljeSE |
Principal Investigator: | Wolfgang Kühn | Quintiles AB Phase 1 Services Strandbodgatan Uppsala, Sweden+ |
Responsible Party: | AstraZeneca R&D Södertälje ( Rolf Karlsten ) |
Study ID Numbers: | D3120C00003 |
Study First Received: | May 30, 2008 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00689780 |
Health Authority: | Sweden: Medical Products Agency; Sweden: Regional Ethical Review Board |
Pain safety chronic low back pain |
Signs and Symptoms Neurologic Manifestations Low Back Pain |
Pain Midazolam Back Pain |
Nervous System Diseases |