PainPhase 2OA19NCT00878501

Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of AZD1386 in Patients With Osteoarthritis (OA) of the Knee

A Phase 2 study testing AZD1386 in people with Pain, run by AstraZeneca at 41 sites in 7 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The primary aim of this study is to investigate if AZD1386 is efficacious as an analgesic in patients with osteoarthritis of the knee and at what dose. 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 40 to 80 years
Conditions the study is for: 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: 241 participants
Where: 41 sitesin 7 countries
Study dates: Mar 2009to Jul 2009
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 40 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with OA of the knee
Male or non pregnant females 40 and 80 years old

Who cannot join

A current diagnosis of another form of arthritis, in addition to OA
History, and/or presence of somatic disease, which may interfere with the objectives

Trial locations and contacts

41 sites in 7 countries.

Country

City, postcode or hospital

41 sites in 7 countries

Canada11 sites

Research Site
Bay Roberts, Newfoundland and Labrador
Research Site
Brampton, Ontario
Research Site
Charlottetown, Prince Edward Island
Research Site
Etobicoke, Ontario
Research Site
Halifax, Nova Scotia
Research Site
Hamilton, Ontario
Research Site
Newmarket, Ontario
Research Site
Saint Romuald, Quebec
Research Site
Sherbrooke, Quebec
Research Site
St. Catharines, Ontario
Research Site
St. John's, Newfoundland and Labrador

Other trials in Canada

Slovakia8 sites

Research Site
Brastislava
Research Site
Komárno
Research Site
Liptovský Hrádok
Research Site
Poprad
Research Site
Považská Bystrica
Research Site
Rimavská Sobota
Research Site
Žiar nad Hronom
Research Site
Žilina

Other trials in Slovakia

Poland7 sites

Research Site
Bialystok
Research Site
Elblag
Research Site
Gdynia
Research Site
Krakow
Research Site
Lublin
Research Site
Toru
Research Site
Warsaw

Other trials in Poland

Finland6 sites

Research Site
Helsinki
Research Site
Hyvinkää
Research Site
Lahti
Research Site
Riihimäki
Research Site
Tampere
Research Site
Vantaa

Other trials in Finland

Hungary6 sites

Research Site
Békéscsaba
Research Site
Budapest
Research Site
Debrecen
Research Site
Miskolc
Research Site
Nyíregyháza
Research Site
Veszprém

Other trials in Hungary

Bulgaria2 sites

Research Site
Pleven
Research Site
Sofia

Other trials in Bulgaria

Japan1 site

Research Site
Japan

Other trials in Japan

About this study

Official title: A Phase II Randomised, Double-blind, Parallel Group, 4-week Treatment, Adaptive Dose Finding, Multi-centre Study Evaluating the Efficacy, Safety, Tolerability and Pharmacokinetics of up to Three Different Oral Doses of AZD1386 and Placebo in Patients With Osteoarthritis of the Knee

Conditions: Pain
Being tested: AZD1386, Placebo
Keywords: Phase II, Pain
Medical subject headings: Pain

What participants receive

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

AZD1386Drug
oral, during 4 weeks
AZD1386Drug
oral, during 4 weeks
PlaceboDrug
Oral, during 4 weeks

Study groups in NCT00878501
Study group	Role	What they receive
AZD1386, 90 mg	Experimental	Not described Receives: Drug: AZD1386
AZD1386, 30 mg	Experimental	Not described Receives: Drug: AZD1386
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscale, 48 Hours Recall.
The WOMAC pain subscale is a self-administered electronic scale with 5 questions (Walking on flat surface, Going up or down stairs, At night while in bed, Sitting or lying, Standing upright). Responses were recorded on a 50-mm line with 100 units. 0 mm indicated no pain and 50 mm indicated extreme pain. The scores were then converted to a 100-mm scale. WOMAC pain was derived by calculating the mean of the VAS scores from the 5 questions with score scale ranging from 0 to 100, 0 being no pain and 100 extreme pain.
Measured: Baseline, week 2, week 4.

Secondary outcomes (3)

Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Subscale, 48 Hours Recall.
The WOMAC VA 3.1. is a self-administered electronic questionnaire that assesses pain, stiffness and disability related to OA. The Function (daily activities) subscale consists of 17 questions. WOMAC function was derived by calculating the mean of the VAS scores from the 17 questions with scores ranging from 0 to 100, 0 = no difficulty in performing daily activities and 100 = extreme difficulty.
Measured: Baseline, Week 2 and Week 4.
Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Stiffness Subscale, 48 Hours Recall.
The WOMAC VA3.1. is a self-administered questionnaire that assesses pain, stiffness and disability related to osteoarthritis. The Stiffness subscale consists of 2 questions (Severity of stiffness after first awakening in the morning and severity of stiffnes after periods of inactivity later in the day). WOMAC stiffness was derived by calculating the mean of the VAS scores from the 2 questions with score scale ranging from 0 to 100, 0 being no stiffness and 100 extreme stiffness.
Measured: Baseline, Week 2 and Week 4.
Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score, 48 Hours Recall
The WOMAC VA3.1. is a self-administered questionnaire that assesses pain, stiffness and disability related to osteoarthritis. It consists of a pain subscale (5 questions), function subscale (17 questions). and a stiffness subscale (2 questions). The total score was derived by calculating the mean of the VAS scores from all 24 questions with score scale ranging from 0 to 100, 0 being no pain, stiffness and difficulty in performing daily activities and 100 being extreme pain, stiffness and difficulty in performing daily activities.
Measured: Baseline, Week 2 and Week 4.

Timeline

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

Mar 2009Jul 2009

First posted9 Apr 2009 (estimated)
Study startMar 2009
Primary completionJul 2009
Study completionJul 2009

Why it stopped: The study was terminated after the planned interim analysis.

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.
Publications (1)Papers the sponsor has linked to this study.
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: 241 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00878501
Sponsor's protocol ID: D5090C00019
Acronym: OA19
Status last verified: May 2012
First submitted: 8 Apr 2009
Last updated: 4 Jun 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Miller F, Bjornsson M, Svensson O, Karlsten R. Experiences with an adaptive design for a dose-finding study in patients with osteoarthritis. Contemp Clin Trials. 2014 Mar;37(2):189-99. doi: 10.1016/j.cct.2013.12.007. Epub 2014 Jan 3.
PubMed 24394343

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

Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain

All Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Randomised, Double-blind, Parallel Group, 4-week Treatment, Adaptive Dose Finding, Multi-centre Study Evaluating the Efficacy, Safety, Tolerability and Pharmacokinetics of up to Three Different Oral Doses of AZD1386 and Placebo in Patients With Osteoarthritis of the Knee
ClinicalTrials.gov ID: NCT00878501
Acronym / sponsor ID: OA19 / D5090C00019
Conditions: Pain
Keywords: Phase II, Pain
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was terminated after the planned interim analysis.
Enrolment: 241 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Mar 2009
Primary completion: Jul 2009 (actual)
Study completion: Jul 2009 (actual)
First posted: 9 Apr 2009 (estimated)
Results: Posted 28 May 2012

Clinical summary

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

Study design

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

Arm	Type	Receives
AZD1386, 90 mg	Experimental	Drug: AZD1386
AZD1386, 30 mg	Experimental	Drug: AZD1386
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients with OA of the knee
Male or non pregnant females 40 and 80 years old

Key exclusion criteria (2 listed)

A current diagnosis of another form of arthritis, in addition to OA
History, and/or presence of somatic disease, which may interfere with the objectives

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
AZD1386oral, during 4 weeks	Drug	AZD1386, 90 mg
AZD1386oral, during 4 weeks	Drug	AZD1386, 30 mg
PlaceboOral, during 4 weeks	Drug	Placebo

Primary outcome

Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscale, 48 Hours Recall.
Time frame: Baseline, week 2, week 4.
The WOMAC pain subscale is a self-administered electronic scale with 5 questions (Walking on flat surface, Going up or down stairs, At night while in bed, Sitting or lying, Standing upright). Responses were recorded on a 50-mm line with 100 units. 0 mm indicated no pain and 50 mm indicated extreme pain. The scores were then converted to a 100-mm scale. WOMAC pain was derived by calculating the mean of the VAS scores from the 5 questions with score scale ranging from 0 to 100, 0 being no pain and 100 extreme pain.

3 secondary outcomes

Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Subscale, 48 Hours Recall.
Time frame: Baseline, Week 2 and Week 4.
Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Stiffness Subscale, 48 Hours Recall.
Time frame: Baseline, Week 2 and Week 4.
Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score, 48 Hours Recall
Time frame: Baseline, Week 2 and Week 4.

Results and safety

Results posted to the registry on 28 May 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental 90 mg	104	87
Experimental 30 mg	44	37
Placebo Control	93	85

Primary outcome: Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscale, 48 Hours Recall.

Time frame: Baseline, week 2, week 4.. Least squares mean (95% Confidence Interval). Unit: mm

Measure	Experimental 90 mg n = 99	Experimental 30 mg n = 42	Placebo Control n = 90
Value	-19.05 (-22.89 to -15.21)	-20.05 (-25.75 to -14.34)	-17.54 (-21.55 to -13.52)

Population analysed: Number of Participants Analyzed for the stated measure are defined according to the Modified Intention To Treat analysis set whereas numbers provided in the Participant Flow Module correspond to number of participants enrolled.

3 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
Experimental 90 mg	0 of 103 (0%)	61 of 103 (59.2%)	Not reported
Experimental 30 mg	1 of 44 (2.3%)	15 of 44 (34.1%)	Not reported
Placebo Control	1 of 93 (1.1%)	14 of 93 (15.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24394343Miller F, Bjornsson M, Svensson O, Karlsten R. Experiences with an adaptive design for a dose-finding study in patients with osteoarthritis. Contemp Clin Trials. 2014 Mar;37(2):189-99. doi: 10.1016/j.cct.2013.12.007. Epub 2014 Jan 3.

Related trials for Pain

Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain

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

AZD1386AstraZeneca R&D Wilmington, USA

Ola Svensson, MD study chair

AZD1386AstraZeneca R&D Södertälje, Sweden

41 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 AZD1386 in people with Pain, run by AstraZeneca at 41 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 2 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 4 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in Canada, Slovakia, Poland, Finland, Hungary 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 28 May 2012). 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?

Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscale, 48 Hours Recall. (time frame: Baseline, week 2, week 4.). 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 NCT00878501, which also lists 1 linked publication.

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 4 Jun 2012.