Study Evaluating the Analgesic Efficacy and Safety of ADL5859 in Participants With Rheumatoid Arthritis
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Study Type:  Interventional 

Study Design:  Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment 
Condition: 
Rheumatoid Arthritis 
Interventions: 
Drug: ADL5859 Drug: Naproxen Drug: Placebo 
Participant Flow
Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations 

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PreAssignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment 

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Reporting Groups
Description  

Part A, Sequence 1: Placebo First, Then ADL5859, Then Naproxen 
Eligible participants were randomized to 1 of 6 treatment sequences. Each treatment sequence had 3 treatment periods, each separated by a washout period of at least 48 hours and up to 1 week between doses. During each treatment period of Part A, participants received a single dose of study medication (placebo, then ADL5859 200 milligrams (mg), then naproxen 500 mg). Part A, Treatment Period 1: matching placebo, capsules, administered orally, as a single dose; Part A, Treatment Period 2: ADL5859 200 mg, capsules, administered orally as a single dose; and Part A, Treatment Period 3: naproxen 500 mg, capsules, administered orally as a single dose 
Part A Sequence 2: ADL5859 First, Then Naproxen, Then Placebo 
Eligible participants were randomized to 1 of 6 treatment sequences. Each treatment sequence had 3 treatment periods, each separated by a washout period of at least 48 hours and up to 1 week between doses. During each treatment period of Part A, participants received a single dose of study medication (ADL5859 200 mg, then naproxen 500 mg, then placebo). Part A, Treatment Period 1: ADL5859 200 mg, capsules, administered orally as a single dose; Part A, Treatment Period 2: naproxen 500 mg, capsules, administered orally as a single dose; and Part A, Treatment Period 3: matching placebo, capsules, administered orally, as a single dose. 
Part A Sequence 3: Naproxen First, Then Placebo, Then ADL5859 
Eligible participants were randomized to 1 of 6 treatment sequences. Each treatment sequence had 3 treatment periods, each separated by a washout period of at least 48 hours and up to 1 week between doses. During each treatment period of Part A, participants received a single dose of study medication (naproxen 500 mg, then placebo, then ADL5859 200 mg). Part A, Treatment Period 1: naproxen 500 mg, capsules, administered orally as a single dose; Part A, Treatment Period 2: matching placebo, capsules, administered orally, as a single dose; and Part A, Treatment Period 3: ADL5859 200 mg, capsules, administered orally as a single dose. 
Part A Sequence 4: Naproxen First, Then ADL5859, Then Placebo 
Eligible participants were randomized to 1 of 6 treatment sequences. Each treatment sequence had 3 treatment periods, each separated by a washout period of at least 48 hours and up to 1 week between doses. During each treatment period of Part A, participants received a single dose of study medication (naproxen 500 mg, then ADL5859 200 mg, then placebo). Part A, Treatment Period 1: naproxen 500 mg, capsules, administered orally as a single dose; Part A, Treatment Period 2: ADL5859 200 mg, capsules, administered orally as a single dose; and Part A, Treatment Period 3: matching placebo, capsules, administered orally, as a single dose. 
Part A Sequence 5: Placebo First, Then Naproxen, Then ADL5859 
Eligible participants were randomized to 1 of 6 treatment sequences. Each treatment sequence had 3 treatment periods, each separated by a washout period of at least 48 hours and up to 1 week between doses. During each treatment period of Part A, participants received a single dose of study medication (placebo, then naproxen 500 mg, then ADL5859 200 mg). Part A, Treatment Period 1: matching placebo, capsules, administered orally, as a single dose; Part A, Treatment Period 2: naproxen 500 mg, capsules, administered orally as a single dose; and Part A, Treatment Period 3: ADL5859 200 mg, capsules, administered orally as a single dose. 
Part A Sequence 6: ADL5859 First, Then Placebo, Then Naproxen 
Eligible participants were randomized to 1 of 6 treatment sequences. Each treatment sequence had 3 treatment periods, each separated by a washout period of at least 48 hours. During each treatment period of Part A, participants received a single dose of study medication (ADL5859 200 mg, then placebo, then naproxen 500 mg). Part A, Treatment Period 1: ADL5859 200 mg, capsules, administered orally as a single dose; Part A, Treatment Period 2: matching placebo, capsules, administered orally, as a single dose; and Part A, Treatment Period 3: naproxen 500 mg, capsules, administered orally as a single dose. 
Part B: ADL5859 100 mg  ADL5859: 100 mg, capsules, administered orally, twice daily (BID) for 2 weeks during Part B of the study 
Part B: Placebo  Matching placebo, capsules, administered orally, BID for 2 weeks during Part B of the study 
Participant Flow for 7 periods
Period 1: Part A  Treatment Period 1
Part A, Sequence 1: Placebo First, Then ADL5859, Then Naproxen  Part A Sequence 2: ADL5859 First, Then Naproxen, Then Placebo  Part A Sequence 3: Naproxen First, Then Placebo, Then ADL5859  Part A Sequence 4: Naproxen First, Then ADL5859, Then Placebo  Part A Sequence 5: Placebo First, Then Naproxen, Then ADL5859  Part A Sequence 6: ADL5859 First, Then Placebo, Then Naproxen  Part B: ADL5859 100 mg  Part B: Placebo  

STARTED  7  7  7  8  9  8  0  0 
Received at Least 1 Dose of Study Drug  7  7  7  8  9  8  0  0 
COMPLETED  6  7  6  8  9  8  0  0 
NOT COMPLETED  1  0  1  0  0  0  0  0 
Adverse Event  1  0  0  0  0  0  0  0 
Withdrawal by Subject  0  0  1  0  0  0  0  0 
Period 2: Part A  Washout Period 1
Part A, Sequence 1: Placebo First, Then ADL5859, Then Naproxen  Part A Sequence 2: ADL5859 First, Then Naproxen, Then Placebo  Part A Sequence 3: Naproxen First, Then Placebo, Then ADL5859  Part A Sequence 4: Naproxen First, Then ADL5859, Then Placebo  Part A Sequence 5: Placebo First, Then Naproxen, Then ADL5859  Part A Sequence 6: ADL5859 First, Then Placebo, Then Naproxen  Part B: ADL5859 100 mg  Part B: Placebo  

STARTED  6  7  6  8  9  8  0  0 
COMPLETED  6  7  6  8  9  8  0  0 
NOT COMPLETED  0  0  0  0  0  0  0  0 
Period 3: Part A  Treatment Period 2
Part A, Sequence 1: Placebo First, Then ADL5859, Then Naproxen  Part A Sequence 2: ADL5859 First, Then Naproxen, Then Placebo  Part A Sequence 3: Naproxen First, Then Placebo, Then ADL5859  Part A Sequence 4: Naproxen First, Then ADL5859, Then Placebo  Part A Sequence 5: Placebo First, Then Naproxen, Then ADL5859  Part A Sequence 6: ADL5859 First, Then Placebo, Then Naproxen  Part B: ADL5859 100 mg  Part B: Placebo  

STARTED  6  7  6  8  9  8  0  0 
Received at Least 1 Dose of Study Drug  6  7  6  8  9  8  0  0 
COMPLETED  6  7  6  8  9  8  0  0 
NOT COMPLETED  0  0  0  0  0  0  0  0 
Period 4: Part A  Washout Period 2
Part A, Sequence 1: Placebo First, Then ADL5859, Then Naproxen  Part A Sequence 2: ADL5859 First, Then Naproxen, Then Placebo  Part A Sequence 3: Naproxen First, Then Placebo, Then ADL5859  Part A Sequence 4: Naproxen First, Then ADL5859, Then Placebo  Part A Sequence 5: Placebo First, Then Naproxen, Then ADL5859  Part A Sequence 6: ADL5859 First, Then Placebo, Then Naproxen  Part B: ADL5859 100 mg  Part B: Placebo  

STARTED  6  7  6  8  9  8  0  0 
COMPLETED  6  7  6  8  9  8  0  0 
NOT COMPLETED  0  0  0  0  0  0  0  0 
Period 5: Part A  Treatment Period 3
Part A, Sequence 1: Placebo First, Then ADL5859, Then Naproxen  Part A Sequence 2: ADL5859 First, Then Naproxen, Then Placebo  Part A Sequence 3: Naproxen First, Then Placebo, Then ADL5859  Part A Sequence 4: Naproxen First, Then ADL5859, Then Placebo  Part A Sequence 5: Placebo First, Then Naproxen, Then ADL5859  Part A Sequence 6: ADL5859 First, Then Placebo, Then Naproxen  Part B: ADL5859 100 mg  Part B: Placebo  

STARTED  6  7  6  8  9  8  0  0 
Received at Least 1 Dose of Study Drug  6  7  6  8  9  8  0  0 
COMPLETED  6  7  6  8  9  8  0  0 
NOT COMPLETED  0  0  0  0  0  0  0  0 
Period 6: Rerandomization Period for Part B
Part A, Sequence 1: Placebo First, Then ADL5859, Then Naproxen  Part A Sequence 2: ADL5859 First, Then Naproxen, Then Placebo  Part A Sequence 3: Naproxen First, Then Placebo, Then ADL5859  Part A Sequence 4: Naproxen First, Then ADL5859, Then Placebo  Part A Sequence 5: Placebo First, Then Naproxen, Then ADL5859  Part A Sequence 6: ADL5859 First, Then Placebo, Then Naproxen  Part B: ADL5859 100 mg  Part B: Placebo  

STARTED  0  0  0  0  0  0  20  24 
COMPLETED  0  0  0  0  0  0  20  24 
NOT COMPLETED  0  0  0  0  0  0  0  0 
Period 7: Part B
Part A, Sequence 1: Placebo First, Then ADL5859, Then Naproxen  Part A Sequence 2: ADL5859 First, Then Naproxen, Then Placebo  Part A Sequence 3: Naproxen First, Then Placebo, Then ADL5859  Part A Sequence 4: Naproxen First, Then ADL5859, Then Placebo  Part A Sequence 5: Placebo First, Then Naproxen, Then ADL5859  Part A Sequence 6: ADL5859 First, Then Placebo, Then Naproxen  Part B: ADL5859 100 mg  Part B: Placebo  

STARTED  0  0  0  0  0  0  20  24 
COMPLETED  0  0  0  0  0  0  19  23 
NOT COMPLETED  0  0  0  0  0  0  1  1 
Lost to Followup  0  0  0  0  0  0  1  0 
Withdrawal by Subject  0  0  0  0  0  0  0  1 
Baseline Characteristics
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

All participants who received at least 1 dose of study drug 
Reporting Groups
Description  

All Treated Participants  All participants who received at least 1 dose of study drug during any sequence of Part A of the study. Baseline measures reported in aggregate for all participants to avoid double counting of Parts A and B. 
Baseline Measures
All Treated Participants  

Number of Participants
[units: participants] 
46 
Age
[units: years] Mean (Standard Deviation) 
54.6 (8.91) 
Gender
[units: participants] 

Female  36 
Male  10 
Outcome Measures
1. Primary:  Part A: Average Difference Between Baseline and Post Dose Evoked (by Treadmill Walking) LowerExtremity Pain Intensity Scores (AELEPID) Over the 6 Hours After Dosing [ Time Frame: Baseline through 6 hours post dose ] 
2. Primary:  Part B: The Mean of Daily Average "Now" Lower Extremity Pain Intensity (LEPI) Score During the 2Week Period [ Time Frame: Baseline through 2 Weeks ] 
3. Secondary:  Part A: Pain Intensity Score (NPRS Score) for Overall Pain, for Lower Extremity Pain, and for Evoked (by Treadmill Walking) Lower Extremity Pain [ Time Frame: Baseline up to 12 hours post dose ] 
4. Secondary:  Part B: Mean Daily LEPI Scores for Weeks 1 and 2 [ Time Frame: Baseline through Week 1 and Week 1 through Week 2 ] 
5. Secondary:  Part A: Pain Intensity Difference Between Baseline and the Value at Each Scheduled Time Point for Overall Pain [ Time Frame: Baseline, 6 and 12 hours post dose ] 
6. Secondary:  Part A: Average Difference Between Baseline and Postdose Evoked Lower Extremity Pain Over the 4 Hours After Dosing [ Time Frame: Baseline, 4 hours post dose ] 
7. Secondary:  Part A: Mean Peak Difference in ELEPI According to the NPRS Scale [ Time Frame: Baseline, Up to 6 hours post dose ] 
8. Secondary:  Part A: Percentage of Participants in Each Treatment Group Achieving a 25%, 50%, or 75% Reduction From Baseline in Evoked Lower Extremity Pain Intensity Scores [ Time Frame: Up to 2, 4, and 6 hours post dosing ] 
9. Secondary:  Part B: Participants’ Global Evaluation of Study Medication [ Time Frame: Up to Week 1 and Week 2 ] 
10. Secondary:  Part B: Mean Daily Average LEPI Scores Over the Last 24 Hours at Week 1 and Week 2 [ Time Frame: Week 1 and Week 2 ] 
11. Secondary:  Part B: Mean Daily Average Overall Pain Intensity Scores Over Week 1, Over Week 2, and Over a 2Week Period [ Time Frame: Baseline through Week 1, Week 1 through Week 2, and Baseline through Week 2 ] 
12. Secondary:  Part B: Percentage of Participants Using Rescue Medication [ Time Frame: Baseline through Week 2 ] 
13. Secondary:  Part A: Participant’s Global Evaluation of Study Medication [ Time Frame: 6 hours post dose during Treatment Periods 1, 2, and 3 of Part A ] 
Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data 

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More Information
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.  
The agreement is:

Results Point of Contact:
Organization: Cubist Pharmaceuticals
phone: 1.781.860.8660
Responsible Party:  Cubist Pharmaceuticals LLC 
ClinicalTrials.gov Identifier:  NCT00626275 History of Changes 
Other Study ID Numbers: 
33CL232 
Study First Received:  February 22, 2008 
Results First Received:  April 27, 2015 
Last Updated:  June 4, 2015 
Health Authority:  United States: Food and Drug Administration 