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Trial record 32 of 34 for:    "Osteoarthritis" | ( Map: Japan )

Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of AZD1386 in Patients With Osteoarthritis (OA) of the Knee (OA19)

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ClinicalTrials.gov Identifier: NCT00878501
Recruitment Status : Terminated (The study was terminated after the planned interim analysis.)
First Posted : April 9, 2009
Results First Posted : May 28, 2012
Last Update Posted : June 4, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Pain
Interventions Drug: AZD1386
Drug: Placebo
Enrollment 241
Recruitment Details International multi-center study, 41sites in North America, Japan and Europe recruited between March and July 2009. 327 participants enrolled into the study
Pre-assignment Details 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)
Arm/Group Title Experimental 90 mg Experimental 30 mg Placebo Control
Hide Arm/Group Description AZD1386 90 mg twice a day (bid) for 4 weeks AZD1386 30 mg twice a day (bid) for 4 weeks Placebo bid for 4 weeks
Period Title: Overall Study
Started 104 [1] 44 93
Interim Analysis 83 37 81
Completed 87 37 85
Not Completed 17 7 8
Reason Not Completed
Adverse Event             11             3             3
Lack of Efficacy             2             1             0
Withdrawal by Subject             2             1             2
Protocol Violation             0             0             1
Incorrect enrolment             1             2             0
Intake of prohibited concom. medication             0             0             1
Mis-randomisation of patient             1             0             0
Administrative             0             0             1
[1]
One of these patients did not receive study drug since incorrectly enrolled (mis-randomisation)
Arm/Group Title Experimental 90 mg Experimental 30 mg Placebo Control Total
Hide Arm/Group Description AZD1386 90 mg twice a day (bid) for 4 weeks AZD1386 30 mg twice a day (bid) for 4 weeks Placebo bid for 4 weeks Total of all reporting groups
Overall Number of Baseline Participants 104 44 93 241
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
median and range Number Analyzed 104 participants 44 participants 93 participants 241 participants
62
(40 to 79)
61
(40 to 79)
61
(40 to 79)
62
(40 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 44 participants 93 participants 241 participants
Female
70
  67.3%
32
  72.7%
65
  69.9%
167
  69.3%
Male
34
  32.7%
12
  27.3%
28
  30.1%
74
  30.7%
1.Primary Outcome
Title Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscale, 48 Hours Recall.
Hide Description 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.
Time Frame Baseline, week 2, week 4.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Experimental 90 mg Experimental 30 mg Placebo Control
Hide Arm/Group Description:
AZD1386 90 mg twice a day (bid) for 4 weeks
AZD1386 30 mg twice a day (bid) for 4 weeks
Placebo bid for 4 weeks
Overall Number of Participants Analyzed 99 42 90
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mm
-19.05
(-22.89 to -15.21)
-20.05
(-25.75 to -14.34)
-17.54
(-21.55 to -13.52)
2.Secondary Outcome
Title Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Subscale, 48 Hours Recall.
Hide Description 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.
Time Frame Baseline, Week 2 and Week 4.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Experimental 90 mg Experimental 30 mg Placebo Control
Hide Arm/Group Description:
AZD1386 90 mg twice a day (bid) for 4 weeks
AZD1386 30 mg twice a day (bid) for 4 weeks
Placebo bid for 4 weeks
Overall Number of Participants Analyzed 99 42 90
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mm
-17.19
(-21.17 to -13.21)
-18.84
(-24.66 to -13.01)
-17.12
(-21.29 to -12.96)
3.Secondary Outcome
Title Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Stiffness Subscale, 48 Hours Recall.
Hide Description 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.
Time Frame Baseline, Week 2 and Week 4.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Experimental 90 mg Experimental 30 mg Placebo Control
Hide Arm/Group Description:
AZD1386 90 mg twice a day (bid) for 4 weeks
AZD1386 30 mg twice a day (bid) for 4 weeks
Placebo bid for 4 weeks
Overall Number of Participants Analyzed 99 42 90
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mm
-16.05
(-20.19 to -11.91)
-17.49
(-23.62 to -11.37)
-17.48
(-21.82 to -13.14)
4.Secondary Outcome
Title Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score, 48 Hours Recall
Hide Description 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.
Time Frame Baseline, Week 2 and Week 4.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Experimental 90 mg Experimental 30 mg Placebo Control
Hide Arm/Group Description:
AZD1386 90 mg twice a day (bid) for 4 weeks
AZD1386 30 mg twice a day (bid) for 4 weeks
Placebo bid for 4 weeks
Overall Number of Participants Analyzed 99 42 90
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mm
-17.48
(-21.35 to -13.61)
-18.93
(-24.63 to -13.24)
-17.27
(-21.33 to -13.22)
Time Frame [Not Specified]
Adverse Event Reporting Description One participant in the Experimental 90 mg Arm did not receive study drug since incorrectly enrolled and is therefore not included.
 
Arm/Group Title Experimental 90 mg Experimental 30 mg Placebo Control
Hide Arm/Group Description AZD1386 90 mg twice a day (bid) for 4 weeks AZD1386 30 mg twice a day (bid) for 4 weeks Placebo bid for 4 weeks
All-Cause Mortality
Experimental 90 mg Experimental 30 mg Placebo Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Experimental 90 mg Experimental 30 mg Placebo Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/103 (0.00%)   1/44 (2.27%)   1/93 (1.08%) 
Cardiac disorders       
Acute Myocardial Infarction  1  0/103 (0.00%)  0/44 (0.00%)  1/93 (1.08%) 
Infections and infestations       
Appendicitis  1  0/103 (0.00%)  1/44 (2.27%)  0/93 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Experimental 90 mg Experimental 30 mg Placebo Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   61/103 (59.22%)   15/44 (34.09%)   14/93 (15.05%) 
Gastrointestinal disorders       
Hypoaesthesia oral  1  10/103 (9.71%)  2/44 (4.55%)  3/93 (3.23%) 
General disorders       
Feeling cold  1  7/103 (6.80%)  1/44 (2.27%)  1/93 (1.08%) 
Injury, poisoning and procedural complications       
Thermal burn  1  4/103 (3.88%)  3/44 (6.82%)  0/93 (0.00%) 
Nervous system disorders       
Dysgeusia  1  15/103 (14.56%)  2/44 (4.55%)  1/93 (1.08%) 
Hypoaesthesia  1  6/103 (5.83%)  1/44 (2.27%)  1/93 (1.08%) 
Headache  1  3/103 (2.91%)  1/44 (2.27%)  5/93 (5.38%) 
Skin and subcutaneous tissue disorders       
Hyperhidrosis  1  8/103 (7.77%)  3/44 (6.82%)  0/93 (0.00%) 
Vascular disorders       
Hot flush  1  8/103 (7.77%)  5/44 (11.36%)  3/93 (3.23%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Gerard Lynch
Organization: AstraZeneca
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00878501     History of Changes
Other Study ID Numbers: D5090C00019
First Submitted: April 8, 2009
First Posted: April 9, 2009
Results First Submitted: January 27, 2011
Results First Posted: May 28, 2012
Last Update Posted: June 4, 2012