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The study was terminated after the planned interim analysis.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD1386, 90 mg | Experimental |
| |
| AZD1386, 30 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1386 | Drug | oral, during 4 weeks |
| |
| AZD1386 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, week 2, week 4. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard L Leff, MD | AZD1386AstraZeneca R&D Wilmington, USA | Study Director |
| Ola Svensson, MD | AZD1386AstraZeneca R&D Södertälje, Sweden | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Pleven | Bulgaria | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24394343 | Derived | 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. |
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Patients with past or ongoing intolerability to NSAID´s/COX-2's or paracetamol/acetaminophen or patients with insufficient pain relief from these treatments were included in the study. The WOMAC pain on walking had to be ≥40 mm and ≤90 mm on a Visual Analogue Scale (VAS) at both enrolment and after 1 weeks wash-out of medication (randomisation)
International multi-center study, 41sites in North America, Japan and Europe recruited between March and July 2009. 327 participants enrolled into the study
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental 90 mg | AZD1386 90 mg twice a day (bid) for 4 weeks |
| FG001 | Experimental 30 mg | AZD1386 30 mg twice a day (bid) for 4 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
oral, during 4 weeks |
|
| Placebo | Drug | Oral, during 4 weeks |
|
| 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. | 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. | Baseline, Week 2 and Week 4. |
| Sofia |
| Bulgaria |
| Research Site | Bay Roberts | Newfoundland and Labrador | Canada |
| Research Site | St. John's | Newfoundland and Labrador | Canada |
| Research Site | Halifax | Nova Scotia | Canada |
| Research Site | Brampton | Ontario | Canada |
| Research Site | Etobicoke | Ontario | Canada |
| Research Site | Hamilton | Ontario | Canada |
| Research Site | Newmarket | Ontario | Canada |
| Research Site | St. Catharines | Ontario | Canada |
| Research Site | Charlottetown | Prince Edward Island | Canada |
| Research Site | Saint Romuald | Quebec | Canada |
| Research Site | Sherbrooke | Quebec | Canada |
| Research Site | Helsinki | Finland |
| Research Site | Hyvinkää | Finland |
| Research Site | Lahti | Finland |
| Research Site | Riihimäki | Finland |
| Research Site | Tampere | Finland |
| Research Site | Vantaa | Finland |
| Research Site | Békéscsaba | Hungary |
| Research Site | Budapest | Hungary |
| Research Site | Debrecen | Hungary |
| Research Site | Miskolc | Hungary |
| Research Site | NyÃregyháza | Hungary |
| Research Site | Veszprém | Hungary |
| Research Site | Japan | Japan |
| Research Site | Bialystok | Poland |
| Research Site | Elblag | Poland |
| Research Site | Gdynia | Poland |
| Research Site | Krakow | Poland |
| Research Site | Lublin | Poland |
| Research Site | Toru | Poland |
| Research Site | Warsaw | Poland |
| Research Site | Brastislava | Slovakia |
| Research Site | Komárno | Slovakia |
| Research Site | Liptovský Hrádok | Slovakia |
| Research Site | Poprad | Slovakia |
| Research Site | Považská Bystrica | Slovakia |
| Research Site | Rimavská Sobota | Slovakia |
| Research Site | Žiar nad Hronom | Slovakia |
| Research Site | Žilina | Slovakia |
| FG002 | Placebo Control | Placebo bid for 4 weeks |
| Interim Analysis |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental 90 mg | AZD1386 90 mg twice a day (bid) for 4 weeks |
| BG001 | Experimental 30 mg | AZD1386 30 mg twice a day (bid) for 4 weeks |
| BG002 | Placebo Control | Placebo bid for 4 weeks |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median | Full Range | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | mm | Baseline, week 2, week 4. |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | mm | Baseline, Week 2 and Week 4. |
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | mm | Baseline, Week 2 and Week 4. |
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | mm | Baseline, Week 2 and Week 4. |
|
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One participant in the Experimental 90 mg Arm did not receive study drug since incorrectly enrolled and is therefore not included.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental 90 mg | AZD1386 90 mg twice a day (bid) for 4 weeks | 0 | 103 | 61 | 103 | ||
| EG001 | Experimental 30 mg | AZD1386 30 mg twice a day (bid) for 4 weeks | 1 | 44 | 15 | 44 | ||
| EG002 | Placebo Control | Placebo bid for 4 weeks | 1 | 93 | 14 | 93 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Myocardial Infarction | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysgeusia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Feeling cold | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C574562 | AZD1386 |
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| Male |
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| Units | Counts |
|---|---|
| Participants |
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