Trial Outcomes & Findings for Study Evaluating the Analgesic Efficacy and Safety of ADL5859 in Participants With Rheumatoid Arthritis (NCT NCT00626275)

Last Updated: 2015-07-01

Results Overview

Approximately 1 hour before baseline and again approximately 45 minutes before the 2-, 4-, and 6-hour time points, participants rested for 45 minutes, then they started the treadmill walk at 15 minutes before baseline and at the 2-, 4-, and 6-hour time points. After the treadmill walk, participants were asked to rate their lower extremity pain on an 11 point Numeric Pain Rating Scale (NPRS), with 0 indicating No Pain and 10 indicating Worst Possible Pain. The average difference between baseline and 6 hours post dose evoked lower-extremity pain intensity scores (AELEPID-6) is presented for each treatment group. Difference = predose (baseline) NPRS score - NPRS score 6 hours post dose. Least square (LS) means and standard errors (SE) were calculated from an analysis-of-covariance (ANCOVA) model with fixed effects for sequence, treatment, period, predose evoked lower extremity pain intensity as a covariate, and a random effect for participant nested within sequence.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

46 participants

Primary outcome timeframe

Baseline through 6 hours post dose

Results posted on

2015-07-01

Participant Flow

Participant milestones

Participant milestones
Measure	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	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 A - Treatment Period 1 STARTED	0	0	7	7	7	8	9	8
Part A - Treatment Period 1 Received at Least 1 Dose of Study Drug	0	0	7	7	7	8	9	8
Part A - Treatment Period 1 COMPLETED	0	0	6	7	6	8	9	8
Part A - Treatment Period 1 NOT COMPLETED	0	0	1	0	1	0	0	0
Part A - Washout Period 1 STARTED	0	0	6	7	6	8	9	8
Part A - Washout Period 1 COMPLETED	0	0	6	7	6	8	9	8
Part A - Washout Period 1 NOT COMPLETED	0	0	0	0	0	0	0	0
Part A - Treatment Period 2 STARTED	0	0	6	7	6	8	9	8
Part A - Treatment Period 2 Received at Least 1 Dose of Study Drug	0	0	6	7	6	8	9	8
Part A - Treatment Period 2 COMPLETED	0	0	6	7	6	8	9	8
Part A - Treatment Period 2 NOT COMPLETED	0	0	0	0	0	0	0	0
Part A - Washout Period 2 STARTED	0	0	6	7	6	8	9	8
Part A - Washout Period 2 COMPLETED	0	0	6	7	6	8	9	8
Part A - Washout Period 2 NOT COMPLETED	0	0	0	0	0	0	0	0
Part A - Treatment Period 3 STARTED	0	0	6	7	6	8	9	8
Part A - Treatment Period 3 Received at Least 1 Dose of Study Drug	0	0	6	7	6	8	9	8
Part A - Treatment Period 3 COMPLETED	0	0	6	7	6	8	9	8
Part A - Treatment Period 3 NOT COMPLETED	0	0	0	0	0	0	0	0
Re-randomization Period for Part B STARTED	20	24	0	0	0	0	0	0
Re-randomization Period for Part B COMPLETED	20	24	0	0	0	0	0	0
Re-randomization Period for Part B NOT COMPLETED	0	0	0	0	0	0	0	0
Part B STARTED	20	24	0	0	0	0	0	0
Part B COMPLETED	19	23	0	0	0	0	0	0
Part B NOT COMPLETED	1	1	0	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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 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 - Treatment Period 1 Adverse Event	0	0	1	0
Part A - Treatment Period 1 Withdrawal by Subject	0	0	0	1
Part B Lost to Follow-up	1	0	0	0
Part B Withdrawal by Subject	0	1	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Treated Participants n=46 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.
Age, Continuous	54.6 years STANDARD_DEVIATION 8.91 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline through 6 hours post dose

Population: Participants in Part A who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.

Outcome measures

Outcome measures
Measure	Placebo (Part A) n=45 Participants Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study	Naproxen - 500 mg (Part A) n=45 Participants Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study	ADL5859 - 200 mg (Part A) n=44 Participants ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
Part A: Average Difference Between Baseline and Post Dose Evoked (by Treadmill Walking) Lower-Extremity Pain Intensity Scores (AELEPID) Over the 6 Hours After Dosing	1.12 units on a scale Standard Error 0.240	1.95 units on a scale Standard Error 0.240	1.20 units on a scale Standard Error 0.242

PRIMARY outcome

Timeframe: Baseline through 2 Weeks

Population: Participants in Part B who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.

Participants assessed their "Now" LEPI 3 times each day (morning, midday, and evening at approximately 10 AM, 2 PM, and 8 PM) and before taking any rescue medication. At each time point, participants were asked to rate their lower extremity pain on an 11-point Numeric Pain Rating Scale (NPRS), with 0 indicating No Pain and 10 indicating Worst Possible Pain. If a scheduled pain assessment was taken within 4 hours of rescue medication, the observed pain score was replaced by the pain score obtained right before the rescue medication was taken. LS means and SE were calculated from an analysis-of-covariance model with effect for treatment and baseline "Now" LEPI (before dosing for Treatment Period 1 of Part A) as a covariate. Participants with no postbaseline assessments were excluded from the baseline summary.

Outcome measures

Outcome measures
Measure	Placebo (Part A) n=24 Participants Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study	Naproxen - 500 mg (Part A) n=20 Participants Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study	ADL5859 - 200 mg (Part A) ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
Part B: The Mean of Daily Average "Now" Lower Extremity Pain Intensity (LEPI) Score During the 2-Week Period	4.23 units on a scale Standard Error 0.339	4.21 units on a scale Standard Error 0.371	—

SECONDARY outcome

Timeframe: Baseline up to 12 hours post dose

Population: Participants in Part A who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.

Overall Pain Intensity (OPI), "Now" Lower Extremity Pain Intensity (LEPI), and Evoked Lower Extremity Pain Intensity (ELEPI) were assessed using the 11-point Numeric Pain Rating Scale (NPRS), with 0 indicating No Pain and 10 indicating Worst Possible Pain. OPI was assessed at 15 minutes before dosing for baseline and at 6 and 12 hours (hr) after dosing. At 15 minutes before dosing, during Period 1 only, participants were also asked to assess their average LEPI over the last 24 hours as a baseline measurement. "Now" LEPI was assessed at 15 minutes before dosing for baseline and at the 1-, 2-, 3-, 4-, 5-, 6-, and 12-hour time points. Approximately 1 hour before dosing and approximately 45 minutes before the 2-, 4-, and 6-hour time points, the participant rested for 45 minutes, then (after the "Now" LEPI assessment) he or she started a treadmill walk at 15 minutes before dosing for baseline and at the 2-, 4-, and 6-hour time points, and then assessed ELEPI.

Outcome measures

Outcome measures
Measure	Placebo (Part A) n=45 Participants Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study	Naproxen - 500 mg (Part A) n=45 Participants Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study	ADL5859 - 200 mg (Part A) n=44 Participants ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
Part A: Pain Intensity Score (NPRS Score) for Overall Pain, for Lower Extremity Pain, and for Evoked (by Treadmill Walking) Lower Extremity Pain ELEPI, 2 hr Post Dose	5.47 units on a scale Standard Deviation 1.854	4.71 units on a scale Standard Deviation 1.973	5.45 units on a scale Standard Deviation 1.649
Part A: Pain Intensity Score (NPRS Score) for Overall Pain, for Lower Extremity Pain, and for Evoked (by Treadmill Walking) Lower Extremity Pain ELEPI, 4 hr Post Dose	5.16 units on a scale Standard Deviation 2.174	4.24 units on a scale Standard Deviation 1.760	5.00 units on a scale Standard Deviation 2.035
Part A: Pain Intensity Score (NPRS Score) for Overall Pain, for Lower Extremity Pain, and for Evoked (by Treadmill Walking) Lower Extremity Pain ELEPI, 6 hr Post Dose	4.93 units on a scale Standard Deviation 2.517	4.00 units on a scale Standard Deviation 1.871	4.95 units on a scale Standard Deviation 2.124
Part A: Pain Intensity Score (NPRS Score) for Overall Pain, for Lower Extremity Pain, and for Evoked (by Treadmill Walking) Lower Extremity Pain LEPI, Baseline	6.18 units on a scale Standard Deviation 2.059	5.78 units on a scale Standard Deviation 1.845	5.68 units on a scale Standard Deviation 1.840
Part A: Pain Intensity Score (NPRS Score) for Overall Pain, for Lower Extremity Pain, and for Evoked (by Treadmill Walking) Lower Extremity Pain LEPI, 1 hr Post Dose	5.38 units on a scale Standard Deviation 2.124	5.00 units on a scale Standard Deviation 1.719	5.34 units on a scale Standard Deviation 1.584
Part A: Pain Intensity Score (NPRS Score) for Overall Pain, for Lower Extremity Pain, and for Evoked (by Treadmill Walking) Lower Extremity Pain LEPI, 2 hr Post Dose	5.24 units on a scale Standard Deviation 2.013	4.33 units on a scale Standard Deviation 1.822	4.91 units on a scale Standard Deviation 1.507
Part A: Pain Intensity Score (NPRS Score) for Overall Pain, for Lower Extremity Pain, and for Evoked (by Treadmill Walking) Lower Extremity Pain LEPI, 3 hr Post Dose	4.67 units on a scale Standard Deviation 2.089	4.04 units on a scale Standard Deviation 1.858	4.73 units on a scale Standard Deviation 1.590
Part A: Pain Intensity Score (NPRS Score) for Overall Pain, for Lower Extremity Pain, and for Evoked (by Treadmill Walking) Lower Extremity Pain LEPI, 4 hr Post Dose	4.76 units on a scale Standard Deviation 2.036	3.93 units on a scale Standard Deviation 1.737	4.70 units on a scale Standard Deviation 1.593
Part A: Pain Intensity Score (NPRS Score) for Overall Pain, for Lower Extremity Pain, and for Evoked (by Treadmill Walking) Lower Extremity Pain LEPI, 5 hr Post Dose	4.71 units on a scale Standard Deviation 2.117	3.98 units on a scale Standard Deviation 1.685	4.73 units on a scale Standard Deviation 1.921
Part A: Pain Intensity Score (NPRS Score) for Overall Pain, for Lower Extremity Pain, and for Evoked (by Treadmill Walking) Lower Extremity Pain LEPI, 6 hr Post Dose	4.49 units on a scale Standard Deviation 2.149	3.89 units on a scale Standard Deviation 1.774	4.77 units on a scale Standard Deviation 1.696
Part A: Pain Intensity Score (NPRS Score) for Overall Pain, for Lower Extremity Pain, and for Evoked (by Treadmill Walking) Lower Extremity Pain LEPI, 12 hr Post Dose	5.11 units on a scale Standard Deviation 2.037	3.78 units on a scale Standard Deviation 1.813	4.76 units on a scale Standard Deviation 1.817
Part A: Pain Intensity Score (NPRS Score) for Overall Pain, for Lower Extremity Pain, and for Evoked (by Treadmill Walking) Lower Extremity Pain OPI, Baseline	6.20 units on a scale Standard Deviation 1.89	6.13 units on a scale Standard Deviation 1.753	5.77 units on a scale Standard Deviation 1.710
Part A: Pain Intensity Score (NPRS Score) for Overall Pain, for Lower Extremity Pain, and for Evoked (by Treadmill Walking) Lower Extremity Pain OPI, 6 hr Post Dose	4.80 units on a scale Standard Deviation 2.282	4.04 units on a scale Standard Deviation 1.833	4.91 units on a scale Standard Deviation 1.815
Part A: Pain Intensity Score (NPRS Score) for Overall Pain, for Lower Extremity Pain, and for Evoked (by Treadmill Walking) Lower Extremity Pain ELEPI, Baseline	6.36 units on a scale Standard Deviation 1.873	6.20 units on a scale Standard Deviation 1.471	6.363 units on a scale Standard Deviation 1.806
Part A: Pain Intensity Score (NPRS Score) for Overall Pain, for Lower Extremity Pain, and for Evoked (by Treadmill Walking) Lower Extremity Pain OPI, 12 hr Post Dose	5.03 units on a scale Standard Deviation 1.993	3.73 units on a scale Standard Deviation 1.880	4.89 units on a scale Standard Deviation 1.955

SECONDARY outcome

Timeframe: Baseline through Week 1 and Week 1 through Week 2

Population: Participants in Part B who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.

Outcome measures

Outcome measures
Measure	Placebo (Part A) n=24 Participants Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study	Naproxen - 500 mg (Part A) n=20 Participants Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study	ADL5859 - 200 mg (Part A) ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
Part B: Mean Daily LEPI Scores for Weeks 1 and 2 Over Week 1	4.28 units on a scale Standard Deviation 1.691	4.17 units on a scale Standard Deviation 1.667	—
Part B: Mean Daily LEPI Scores for Weeks 1 and 2 Over Week 2	4.23 units on a scale Standard Deviation 2.090	4.13 units on a scale Standard Deviation 1.756	—

SECONDARY outcome

Timeframe: Baseline, 6 and 12 hours post dose

Population: Participants in Part A who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.

Overall Pain Intensity (OPI) was assessed by the participant using the 11-point Numeric Pain Rating Scale (NPRS), with 0 indicating No Pain and 10 indicating Worst Possible Pain. OPI was assessed at 15 minutes before dosing for baseline and at 6 and 12 hours after dosing. Difference = predose (baseline) OPI score - OPI score 6 and 12 hours post dose.

Outcome measures

Outcome measures
Measure	Placebo (Part A) n=45 Participants Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study	Naproxen - 500 mg (Part A) n=45 Participants Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study	ADL5859 - 200 mg (Part A) n=44 Participants ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
Part A: Pain Intensity Difference Between Baseline and the Value at Each Scheduled Time Point for Overall Pain Change From Baseline 6 Hours Post Dose	1.40 units on a scale Standard Deviation 2.240	2.09 units on a scale Standard Deviation 1.917	0.86 units on a scale Standard Deviation 2.120
Part A: Pain Intensity Difference Between Baseline and the Value at Each Scheduled Time Point for Overall Pain Change From Baseline 12 Hours Post Dose	1.16 units on a scale Standard Deviation 1.911	3.73 units on a scale Standard Deviation 1.880	0.92 units on a scale Standard Deviation 2.278

SECONDARY outcome

Timeframe: Baseline, 4 hours post dose

Population: Participants in Part A who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose

Evoked Lower Extremity Pain Intensity (ELEPI) was assessed using the 11-point Numeric Pain Rating Scale (NPRS), with 0 indicating No Pain and 10 indicating Worst Possible Pain. Approximately 1 hour before dosing and approximately 45 minutes before the 2-, 4-, and 6-hour time points, the participant rested for 45 minutes, then he or she started a treadmill walk at 15 minutes before dosing for baseline and at the 2-, 4-, and 6-hour time points, and then assessed ELEPI. Difference = predose (baseline) ELEPI score - ELEPI score 4 hours post dose.

Outcome measures

Outcome measures
Measure	Placebo (Part A) n=45 Participants Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study	Naproxen - 500 mg (Part A) n=45 Participants Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study	ADL5859 - 200 mg (Part A) n=45 Participants ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
Part A: Average Difference Between Baseline and Postdose Evoked Lower Extremity Pain Over the 4 Hours After Dosing	1.04 units on a scale Standard Deviation 1.437	1.72 units on a scale Standard Deviation 1.753	1.14 units on a scale Standard Deviation 1.553

SECONDARY outcome

Timeframe: Baseline, Up to 6 hours post dose

Population: Participants in Part A who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.

Evoked Lower Extremity Pain Intensity (ELEPI) was assessed using the 11-point NPRS. Participants were asked to rate their lower extremity pain on an 11 point NPRS, with 0 indicating No Pain and 10 indicating Worst Possible Pain. If a scheduled pain assessment was taken within 4 hours of rescue medication, the observed pain score was replaced by the pain score obtained right before the rescue medication was taken. Approximately 1 hour before dosing and approximately 45 minutes before the 2-, 4-, and 6-hour time points, the participant rested for 45 minutes, then he or she started a treadmill walk at 15 minutes before dosing for baseline and at the 2-, 4-, and 6-hour time points, and then assessed ELEPI. Peak ELEPID was defined as the maximum of ELEPIDs recorded at 2, 4, and 6 hours post dose. Difference = predose (baseline) NPRS score - peak NPRS score up to 6 hours post dose.

Outcome measures

Outcome measures
Measure	Placebo (Part A) n=45 Participants Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study	Naproxen - 500 mg (Part A) n=45 Participants Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study	ADL5859 - 200 mg (Part A) n=44 Participants ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
Part A: Mean Peak Difference in ELEPI According to the NPRS Scale	1.82 units on a scale Standard Deviation 1.874	2.49 units on a scale Standard Deviation 1.740	1.84 units on a scale Standard Deviation 1.725

SECONDARY outcome

Timeframe: Up to 2, 4, and 6 hours post dosing

Population: Participants in Part A who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.

Percentage was measured by identifying the number of participants who achieved the desired percentage Reduction From Baseline in ELEPI Score at either 2, 4, and 6 hours post dose and was divided the by the number of total participants in the given group and then multiplied by 100 to equate to a percentage.

Outcome measures

Outcome measures
Measure	Placebo (Part A) n=45 Participants Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study	Naproxen - 500 mg (Part A) n=45 Participants Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study	ADL5859 - 200 mg (Part A) n=44 Participants ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
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 2 Hours Post-Dose, 25% Reduction	28.9 Percentage of Participants	46.7 Percentage of Participants	22.7 Percentage of Participants
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 4 Hours Post-Dose, 25% Reduction	40.0 Percentage of Participants	60.0 Percentage of Participants	36.4 Percentage of Participants
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 6 Hours Post-Dose, 25% Reduction	42.2 Percentage of Participants	64.4 Percentage of Participants	45.5 Percentage of Participants
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 2 Hours Post-Dose, 50% Reduction	4.4 Percentage of Participants	24.4 Percentage of Participants	4.5 Percentage of Participants
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 4 Hours Post-Dose, 50% Reduction	22.2 Percentage of Participants	31.1 Percentage of Participants	15.9 Percentage of Participants
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 6 Hours Post-Dose, 50% Reduction	26.7 Percentage of Participants	33.3 Percentage of Participants	18.2 Percentage of Participants
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 2 Hours Post-Dose, 75% Reduction	0 Percentage of Participants	6.7 Percentage of Participants	0 Percentage of Participants
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 4 Hours Post-Dose, 75% Reduction	0 Percentage of Participants	8.9 Percentage of Participants	6.8 Percentage of Participants
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 6 Hours Post-Dose, 75% Reduction	6.7 Percentage of Participants	11.1 Percentage of Participants	6.8 Percentage of Participants

SECONDARY outcome

Timeframe: Up to Week 1 and Week 2

Population: Participants in Part B who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.

For Part B, each participant's global evaluation (overall impression) of study medication was obtained at each weekly visit. Scores were recorded on the Case Report Form (CRF) on a 5 point scale ranging from "excellent" to "poor". Participant counts per score were reported at Week 1 (Day 7) and Week 2 (Day 14).

Outcome measures

Outcome measures
Measure	Placebo (Part A) n=24 Participants Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study	Naproxen - 500 mg (Part A) n=20 Participants Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study	ADL5859 - 200 mg (Part A) ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
Part B: Participants' Global Evaluation of Study Medication Week 2 - Fair (n=24, 19)	5 Participants	5 Participants	—
Part B: Participants' Global Evaluation of Study Medication Week 2 - Poor (n=24, 19)	5 Participants	3 Participants	—
Part B: Participants' Global Evaluation of Study Medication Week 1 - Excellent (n=23, 20)	2 Participants	3 Participants	—
Part B: Participants' Global Evaluation of Study Medication Week 1 - Very good (n=23, 20)	5 Participants	7 Participants	—
Part B: Participants' Global Evaluation of Study Medication Week 1 - Good (n=23, 20)	6 Participants	4 Participants	—
Part B: Participants' Global Evaluation of Study Medication Week 1 - Fair (n=23, 20)	6 Participants	4 Participants	—
Part B: Participants' Global Evaluation of Study Medication Week 1 - Poor (n=23, 20)	4 Participants	2 Participants	—
Part B: Participants' Global Evaluation of Study Medication Week 2 - Excellent (n=24, 19)	2 Participants	4 Participants	—
Part B: Participants' Global Evaluation of Study Medication Week 2 - Very Good (n=24, 19)	5 Participants	4 Participants	—
Part B: Participants' Global Evaluation of Study Medication Week 2 - Good (n=24, 19)	7 Participants	3 Participants	—

SECONDARY outcome

Timeframe: Week 1 and Week 2

Population: Participants in Part B who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.

Each day during Part B, participants rated their Lower Extremity Pain Intensity over the last 24 hours on an 11-point NPRS, with 0 indicating No Pain and 10 indicating Worst Possible Pain

Outcome measures

Outcome measures
Measure	Placebo (Part A) n=24 Participants Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study	Naproxen - 500 mg (Part A) n=20 Participants Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study	ADL5859 - 200 mg (Part A) ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
Part B: Mean Daily Average LEPI Scores Over the Last 24 Hours at Week 1 and Week 2 Week 1	4.66 units on a scale Standard Deviation 1.872	4.26 units on a scale Standard Deviation 1.741	—
Part B: Mean Daily Average LEPI Scores Over the Last 24 Hours at Week 1 and Week 2 Week 2	4.57 units on a scale Standard Deviation 2.197	4.25 units on a scale Standard Deviation 1.777	—

SECONDARY outcome

Timeframe: Baseline through Week 1, Week 1 through Week 2, and Baseline through Week 2

Population: Participants in Part B who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.

During Part B, participants returned to the clinic for 2 additional visits at approximately weekly intervals for assessments of Overall Pain Index (OPI). Participants rated their OPI on an 11-point Numeric Pain Rating Scale (NPRS) with 0 indicating No Pain and 10 indicating Worst possible pain

Outcome measures

Outcome measures
Measure	Placebo (Part A) n=24 Participants Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study	Naproxen - 500 mg (Part A) n=20 Participants Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study	ADL5859 - 200 mg (Part A) ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
Part B: Mean Daily Average Overall Pain Intensity Scores Over Week 1, Over Week 2, and Over a 2-Week Period Change from Baseline to Week 1	4.26 units on a scale Standard Deviation 2.050	4.26 units on a scale Standard Deviation 1.939	—
Part B: Mean Daily Average Overall Pain Intensity Scores Over Week 1, Over Week 2, and Over a 2-Week Period Change from Week 1 to Week 2	4.33 units on a scale Standard Deviation 2.426	4.06 units on a scale Standard Deviation 1.955	—
Part B: Mean Daily Average Overall Pain Intensity Scores Over Week 1, Over Week 2, and Over a 2-Week Period Change from Baseline to Week 2	4.33 units on a scale Standard Deviation 2.125	4.21 units on a scale Standard Deviation 1.805	—

SECONDARY outcome

Timeframe: Baseline through Week 2

Population: Participants in Part B who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.

The percentage of participants who took at least 1 dose of rescue medication during 2-week treatment period of Part B is presented.

Outcome measures

Outcome measures
Measure	Placebo (Part A) n=24 Participants Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study	Naproxen - 500 mg (Part A) n=20 Participants Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study	ADL5859 - 200 mg (Part A) ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
Part B: Percentage of Participants Using Rescue Medication	45.8 Percentage of Participants	40.0 Percentage of Participants	—

SECONDARY outcome

Timeframe: 6 hours post dose during Treatment Periods 1, 2, and 3 of Part A

Population: Participants in Part A who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.

For each treatment period during Part A, each participant's global evaluation (overall impression) of study medication was obtained 6 hours after dosing. Scores were recorded on the Case Report Form (CRF) on a 5 point scale ranging from "excellent" to "poor". Participant counts per score were reported once in Part A.

Outcome measures

Outcome measures
Measure	Placebo (Part A) n=45 Participants Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study	Naproxen - 500 mg (Part A) n=45 Participants Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study	ADL5859 - 200 mg (Part A) n=44 Participants ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
Part A: Participant's Global Evaluation of Study Medication Excellent	1 participants	6 participants	1 participants
Part A: Participant's Global Evaluation of Study Medication Very Good	9 participants	12 participants	8 participants
Part A: Participant's Global Evaluation of Study Medication Good	15 participants	15 participants	12 participants
Part A: Participant's Global Evaluation of Study Medication Fair	12 participants	9 participants	15 participants
Part A: Participant's Global Evaluation of Study Medication Poor	8 participants	3 participants	8 participants

Adverse Events

Placebo (Part A)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Naproxen - 500 mg (Part A)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

ADL5859 - 200 mg (Part A)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo (Part B)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

ADL5859 - 100 mg (Part B)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo (Part A) n=46 participants at risk Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study	Naproxen - 500 mg (Part A) n=46 participants at risk Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study	ADL5859 - 200 mg (Part A) n=46 participants at risk ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study	Placebo (Part B) n=24 participants at risk Matching placebo, capsules, administered orally, BID for 2 weeks during Part B of the study	ADL5859 - 100 mg (Part B) n=20 participants at risk ADL5859: 100 mg, capsules, administered orally, BID for 2 weeks during Part B of the study
Cardiac disorders Tachycardia	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	2.2% 1/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/24 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/20 Analysis Population: All participants who received at least 1 dose of study drug
Eye disorders Vision Blurred	2.2% 1/46 Analysis Population: All participants who received at least 1 dose of study drug	2.2% 1/46 Analysis Population: All participants who received at least 1 dose of study drug	2.2% 1/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/24 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/20 Analysis Population: All participants who received at least 1 dose of study drug
Gastrointestinal disorders Diarrhea	2.2% 1/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	8.3% 2/24 Analysis Population: All participants who received at least 1 dose of study drug	10.0% 2/20 Analysis Population: All participants who received at least 1 dose of study drug
Gastrointestinal disorders Dry Mouth	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	2.2% 1/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/24 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/20 Analysis Population: All participants who received at least 1 dose of study drug
Gastrointestinal disorders Dyspepsia	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	2.2% 1/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/24 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/20 Analysis Population: All participants who received at least 1 dose of study drug
Gastrointestinal disorders Food Poisoning	2.2% 1/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/24 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/20 Analysis Population: All participants who received at least 1 dose of study drug
Gastrointestinal disorders Nausea	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	2.2% 1/46 Analysis Population: All participants who received at least 1 dose of study drug	4.2% 1/24 Analysis Population: All participants who received at least 1 dose of study drug	10.0% 2/20 Analysis Population: All participants who received at least 1 dose of study drug
General disorders Feeling hot	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	2.2% 1/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/24 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/20 Analysis Population: All participants who received at least 1 dose of study drug
General disorders Pain	2.2% 1/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	4.2% 1/24 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/20 Analysis Population: All participants who received at least 1 dose of study drug
Infections and infestations Urinary Tract Infection	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	2.2% 1/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/24 Analysis Population: All participants who received at least 1 dose of study drug	5.0% 1/20 Analysis Population: All participants who received at least 1 dose of study drug
Investigations Heart Rate Increase	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	2.2% 1/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/24 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/20 Analysis Population: All participants who received at least 1 dose of study drug
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	2.2% 1/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/24 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/20 Analysis Population: All participants who received at least 1 dose of study drug
Nervous system disorders Dizziness	2.2% 1/46 Analysis Population: All participants who received at least 1 dose of study drug	2.2% 1/46 Analysis Population: All participants who received at least 1 dose of study drug	2.2% 1/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/24 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/20 Analysis Population: All participants who received at least 1 dose of study drug
Nervous system disorders Dysgeusia	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	2.2% 1/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/24 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/20 Analysis Population: All participants who received at least 1 dose of study drug
Nervous system disorders Headache	2.2% 1/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	2.2% 1/46 Analysis Population: All participants who received at least 1 dose of study drug	8.3% 2/24 Analysis Population: All participants who received at least 1 dose of study drug	5.0% 1/20 Analysis Population: All participants who received at least 1 dose of study drug
Nervous system disorders Migraine	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	2.2% 1/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/24 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/20 Analysis Population: All participants who received at least 1 dose of study drug
Psychiatric disorders Abnormal Dreams	2.2% 1/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/24 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/20 Analysis Population: All participants who received at least 1 dose of study drug
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	2.2% 1/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/24 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/20 Analysis Population: All participants who received at least 1 dose of study drug
Vascular disorders Hypotension	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	2.2% 1/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/24 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/20 Analysis Population: All participants who received at least 1 dose of study drug
Vascular disorders Orthostatic Hypotension	4.3% 2/46 Analysis Population: All participants who received at least 1 dose of study drug	4.3% 2/46 Analysis Population: All participants who received at least 1 dose of study drug	6.5% 3/46 Analysis Population: All participants who received at least 1 dose of study drug	4.2% 1/24 Analysis Population: All participants who received at least 1 dose of study drug	5.0% 1/20 Analysis Population: All participants who received at least 1 dose of study drug
Vascular disorders Phlebitis	2.2% 1/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/24 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/20 Analysis Population: All participants who received at least 1 dose of study drug
Gastrointestinal disorders Abdominal Distension	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/24 Analysis Population: All participants who received at least 1 dose of study drug	5.0% 1/20 Analysis Population: All participants who received at least 1 dose of study drug
Gastrointestinal disorders Abdominal Tenderness	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/24 Analysis Population: All participants who received at least 1 dose of study drug	5.0% 1/20 Analysis Population: All participants who received at least 1 dose of study drug
Gastrointestinal disorders Constipation	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/24 Analysis Population: All participants who received at least 1 dose of study drug	10.0% 2/20 Analysis Population: All participants who received at least 1 dose of study drug
General disorders Chest Discomfort	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	4.2% 1/24 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/20 Analysis Population: All participants who received at least 1 dose of study drug
General disorders Influenza-like Disorder	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/24 Analysis Population: All participants who received at least 1 dose of study drug	5.0% 1/20 Analysis Population: All participants who received at least 1 dose of study drug
Investigations Blood Glucose Increased	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	4.2% 1/24 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/20 Analysis Population: All participants who received at least 1 dose of study drug
Investigations Haematocrit Decreased	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/24 Analysis Population: All participants who received at least 1 dose of study drug	5.0% 1/20 Analysis Population: All participants who received at least 1 dose of study drug
Investigations Haemoglobin Decreased	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/24 Analysis Population: All participants who received at least 1 dose of study drug	5.0% 1/20 Analysis Population: All participants who received at least 1 dose of study drug
Investigations Red Blood Cell Count Decreased	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/24 Analysis Population: All participants who received at least 1 dose of study drug	5.0% 1/20 Analysis Population: All participants who received at least 1 dose of study drug
Musculoskeletal and connective tissue disorders Joint Swelling	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	4.2% 1/24 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/20 Analysis Population: All participants who received at least 1 dose of study drug
Musculoskeletal and connective tissue disorders Muscle Spasms	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	4.2% 1/24 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/20 Analysis Population: All participants who received at least 1 dose of study drug
Nervous system disorders Somnolence	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/24 Analysis Population: All participants who received at least 1 dose of study drug	5.0% 1/20 Analysis Population: All participants who received at least 1 dose of study drug
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/24 Analysis Population: All participants who received at least 1 dose of study drug	5.0% 1/20 Analysis Population: All participants who received at least 1 dose of study drug
Skin and subcutaneous tissue disorders Rash	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	4.2% 1/24 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/20 Analysis Population: All participants who received at least 1 dose of study drug
Skin and subcutaneous tissue disorders Skin Lesion	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/46 Analysis Population: All participants who received at least 1 dose of study drug	4.2% 1/24 Analysis Population: All participants who received at least 1 dose of study drug	0.00% 0/20 Analysis Population: All participants who received at least 1 dose of study drug

Additional Information

Vice President, Clinical Research

Cubist Pharmaceuticals

Phone: 1.781.860.8660

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER