Trial Outcomes & Findings for Tolerability and Efficacy of Ibuprofen 800 mg in a Walking Model of Osteoarthritis Pain (0000-057) (NCT NCT00565084)
NCT ID: NCT00565084
Last Updated: 2015-04-10
Results Overview
Pain intensities(PIs) were measured at pre-dose and 3 post-dose walks (15 Minutes Each Separated by a 45-Minute Rest Interval) on an 11 point scale(0=no pain; 10=worst pain) and averaged for each walk. Change from baseline was average of post-dose PIs minus average of pre-dose PI.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
33 participants
Primary outcome timeframe
All pain intensities measured from the pre-treatment walk and 3 post-treatment walks (within 3 and half hours post dose, 15 minutes each walk separated by a 45-minute rest interval)
Results posted on
2015-04-10
Participant Flow
First Patient Entered 16 Mar 2007 Multicenter, 3 sites
This study is a single dose, multi-center, randomized, placebo controlled, cross-over study using the Walking Model of Osteoarthritis (OA) knee pain. The efficacy and tolerability of a single dose of Ibuprofen 800 mg in the setting of standardized walks will be compared with placebo.
Participant milestones
| Measure |
Placebo-Placebo-Ibuprofen
First single dose placebo; second single dose placebo; single dose ibuprofen 800 mg
|
Placebo-Ibuprofen-Placebo
First single dose placebo; single dose ibuprofen 800 mg; second single dose placebo
|
Ibuprofen-Placebo-Placebo
Single dose ibuprofen 800 mg; first single dose placebo; second single dose placebo
|
|---|---|---|---|
|
First Treatment Period
STARTED
|
11
|
11
|
11
|
|
First Treatment Period
COMPLETED
|
11
|
11
|
11
|
|
First Treatment Period
NOT COMPLETED
|
0
|
0
|
0
|
|
Second Treatment Period
STARTED
|
11
|
11
|
11
|
|
Second Treatment Period
COMPLETED
|
11
|
11
|
11
|
|
Second Treatment Period
NOT COMPLETED
|
0
|
0
|
0
|
|
Third Treatment Period
STARTED
|
11
|
11
|
11
|
|
Third Treatment Period
COMPLETED
|
11
|
11
|
11
|
|
Third Treatment Period
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tolerability and Efficacy of Ibuprofen 800 mg in a Walking Model of Osteoarthritis Pain (0000-057)
Baseline characteristics by cohort
| Measure |
Overall Study
n=33 Participants
|
|---|---|
|
Age, Continuous
|
60.78 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: All pain intensities measured from the pre-treatment walk and 3 post-treatment walks (within 3 and half hours post dose, 15 minutes each walk separated by a 45-minute rest interval)Population: This is a crossover study. Total number of participants was 33; every participant had one ibuprofen period and two placebo periods.
Pain intensities(PIs) were measured at pre-dose and 3 post-dose walks (15 Minutes Each Separated by a 45-Minute Rest Interval) on an 11 point scale(0=no pain; 10=worst pain) and averaged for each walk. Change from baseline was average of post-dose PIs minus average of pre-dose PI.
Outcome measures
| Measure |
Ibuprofen
n=33 Participants
Single dose ibuprofen 800 mg
|
Placebo 1
n=33 Participants
First Single dose placebo
|
Placebo 2
n=33 Participants
Second Single dose placebo
|
|---|---|---|---|
|
Change in Average Pain Intensities Measured From the Pre-Treatment Walk (Baseline) at 3 Post-Treatment Walks
|
0.24 Units on a Scale
Standard Deviation 0.77
|
0.18 Units on a Scale
Standard Deviation 0.77
|
0.18 Units on a Scale
Standard Deviation 0.77
|
Adverse Events
Placebo-Placebo-Ibuprofen
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo-Ibuprofen-Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Ibuprofen-Placebo-Placebo
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo-Placebo-Ibuprofen
n=11 participants at risk
First single dose placebo; second single dose placebo; single dose ibuprofen 800 mg
|
Placebo-Ibuprofen-Placebo
n=11 participants at risk
First single dose placebo; single dose ibuprofen 800 mg; second single dose placebo
|
Ibuprofen-Placebo-Placebo
n=11 participants at risk
Single dose ibuprofen 800 mg; first single dose placebo; second single dose placebo
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Ductal Cancer Infiltrating
|
0.00%
0/11 • From consent to 14 day follow up after all treatment periods was from 16-Mar-2007 to 10-Dec-2007. First study dosing to last dosing period was from 23-Mar-2007 to 03-Dec-2007.
|
0.00%
0/11 • From consent to 14 day follow up after all treatment periods was from 16-Mar-2007 to 10-Dec-2007. First study dosing to last dosing period was from 23-Mar-2007 to 03-Dec-2007.
|
9.1%
1/11 • Number of events 1 • From consent to 14 day follow up after all treatment periods was from 16-Mar-2007 to 10-Dec-2007. First study dosing to last dosing period was from 23-Mar-2007 to 03-Dec-2007.
|
Other adverse events
| Measure |
Placebo-Placebo-Ibuprofen
n=11 participants at risk
First single dose placebo; second single dose placebo; single dose ibuprofen 800 mg
|
Placebo-Ibuprofen-Placebo
n=11 participants at risk
First single dose placebo; single dose ibuprofen 800 mg; second single dose placebo
|
Ibuprofen-Placebo-Placebo
n=11 participants at risk
Single dose ibuprofen 800 mg; first single dose placebo; second single dose placebo
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/11 • From consent to 14 day follow up after all treatment periods was from 16-Mar-2007 to 10-Dec-2007. First study dosing to last dosing period was from 23-Mar-2007 to 03-Dec-2007.
|
9.1%
1/11 • Number of events 1 • From consent to 14 day follow up after all treatment periods was from 16-Mar-2007 to 10-Dec-2007. First study dosing to last dosing period was from 23-Mar-2007 to 03-Dec-2007.
|
0.00%
0/11 • From consent to 14 day follow up after all treatment periods was from 16-Mar-2007 to 10-Dec-2007. First study dosing to last dosing period was from 23-Mar-2007 to 03-Dec-2007.
|
|
Infections and infestations
Boil on Buttock
|
0.00%
0/11 • From consent to 14 day follow up after all treatment periods was from 16-Mar-2007 to 10-Dec-2007. First study dosing to last dosing period was from 23-Mar-2007 to 03-Dec-2007.
|
0.00%
0/11 • From consent to 14 day follow up after all treatment periods was from 16-Mar-2007 to 10-Dec-2007. First study dosing to last dosing period was from 23-Mar-2007 to 03-Dec-2007.
|
9.1%
1/11 • Number of events 1 • From consent to 14 day follow up after all treatment periods was from 16-Mar-2007 to 10-Dec-2007. First study dosing to last dosing period was from 23-Mar-2007 to 03-Dec-2007.
|
|
Infections and infestations
Cold Symptoms
|
9.1%
1/11 • Number of events 1 • From consent to 14 day follow up after all treatment periods was from 16-Mar-2007 to 10-Dec-2007. First study dosing to last dosing period was from 23-Mar-2007 to 03-Dec-2007.
|
0.00%
0/11 • From consent to 14 day follow up after all treatment periods was from 16-Mar-2007 to 10-Dec-2007. First study dosing to last dosing period was from 23-Mar-2007 to 03-Dec-2007.
|
0.00%
0/11 • From consent to 14 day follow up after all treatment periods was from 16-Mar-2007 to 10-Dec-2007. First study dosing to last dosing period was from 23-Mar-2007 to 03-Dec-2007.
|
|
Infections and infestations
Urinary Track Infection
|
9.1%
1/11 • Number of events 1 • From consent to 14 day follow up after all treatment periods was from 16-Mar-2007 to 10-Dec-2007. First study dosing to last dosing period was from 23-Mar-2007 to 03-Dec-2007.
|
0.00%
0/11 • From consent to 14 day follow up after all treatment periods was from 16-Mar-2007 to 10-Dec-2007. First study dosing to last dosing period was from 23-Mar-2007 to 03-Dec-2007.
|
0.00%
0/11 • From consent to 14 day follow up after all treatment periods was from 16-Mar-2007 to 10-Dec-2007. First study dosing to last dosing period was from 23-Mar-2007 to 03-Dec-2007.
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
0.00%
0/11 • From consent to 14 day follow up after all treatment periods was from 16-Mar-2007 to 10-Dec-2007. First study dosing to last dosing period was from 23-Mar-2007 to 03-Dec-2007.
|
9.1%
1/11 • Number of events 1 • From consent to 14 day follow up after all treatment periods was from 16-Mar-2007 to 10-Dec-2007. First study dosing to last dosing period was from 23-Mar-2007 to 03-Dec-2007.
|
0.00%
0/11 • From consent to 14 day follow up after all treatment periods was from 16-Mar-2007 to 10-Dec-2007. First study dosing to last dosing period was from 23-Mar-2007 to 03-Dec-2007.
|
|
Musculoskeletal and connective tissue disorders
Hip Discomfort
|
0.00%
0/11 • From consent to 14 day follow up after all treatment periods was from 16-Mar-2007 to 10-Dec-2007. First study dosing to last dosing period was from 23-Mar-2007 to 03-Dec-2007.
|
9.1%
1/11 • Number of events 1 • From consent to 14 day follow up after all treatment periods was from 16-Mar-2007 to 10-Dec-2007. First study dosing to last dosing period was from 23-Mar-2007 to 03-Dec-2007.
|
0.00%
0/11 • From consent to 14 day follow up after all treatment periods was from 16-Mar-2007 to 10-Dec-2007. First study dosing to last dosing period was from 23-Mar-2007 to 03-Dec-2007.
|
|
Musculoskeletal and connective tissue disorders
Pain in Joint involving hand
|
0.00%
0/11 • From consent to 14 day follow up after all treatment periods was from 16-Mar-2007 to 10-Dec-2007. First study dosing to last dosing period was from 23-Mar-2007 to 03-Dec-2007.
|
9.1%
1/11 • Number of events 1 • From consent to 14 day follow up after all treatment periods was from 16-Mar-2007 to 10-Dec-2007. First study dosing to last dosing period was from 23-Mar-2007 to 03-Dec-2007.
|
0.00%
0/11 • From consent to 14 day follow up after all treatment periods was from 16-Mar-2007 to 10-Dec-2007. First study dosing to last dosing period was from 23-Mar-2007 to 03-Dec-2007.
|
|
Musculoskeletal and connective tissue disorders
Pain in Hip
|
0.00%
0/11 • From consent to 14 day follow up after all treatment periods was from 16-Mar-2007 to 10-Dec-2007. First study dosing to last dosing period was from 23-Mar-2007 to 03-Dec-2007.
|
0.00%
0/11 • From consent to 14 day follow up after all treatment periods was from 16-Mar-2007 to 10-Dec-2007. First study dosing to last dosing period was from 23-Mar-2007 to 03-Dec-2007.
|
9.1%
1/11 • Number of events 1 • From consent to 14 day follow up after all treatment periods was from 16-Mar-2007 to 10-Dec-2007. First study dosing to last dosing period was from 23-Mar-2007 to 03-Dec-2007.
|
|
Musculoskeletal and connective tissue disorders
Tibia Pain
|
0.00%
0/11 • From consent to 14 day follow up after all treatment periods was from 16-Mar-2007 to 10-Dec-2007. First study dosing to last dosing period was from 23-Mar-2007 to 03-Dec-2007.
|
9.1%
1/11 • Number of events 1 • From consent to 14 day follow up after all treatment periods was from 16-Mar-2007 to 10-Dec-2007. First study dosing to last dosing period was from 23-Mar-2007 to 03-Dec-2007.
|
0.00%
0/11 • From consent to 14 day follow up after all treatment periods was from 16-Mar-2007 to 10-Dec-2007. First study dosing to last dosing period was from 23-Mar-2007 to 03-Dec-2007.
|
|
Musculoskeletal and connective tissue disorders
Unilateral Leg Pain
|
0.00%
0/11 • From consent to 14 day follow up after all treatment periods was from 16-Mar-2007 to 10-Dec-2007. First study dosing to last dosing period was from 23-Mar-2007 to 03-Dec-2007.
|
0.00%
0/11 • From consent to 14 day follow up after all treatment periods was from 16-Mar-2007 to 10-Dec-2007. First study dosing to last dosing period was from 23-Mar-2007 to 03-Dec-2007.
|
9.1%
1/11 • Number of events 1 • From consent to 14 day follow up after all treatment periods was from 16-Mar-2007 to 10-Dec-2007. First study dosing to last dosing period was from 23-Mar-2007 to 03-Dec-2007.
|
|
Nervous system disorders
Sinus Headache
|
9.1%
1/11 • Number of events 3 • From consent to 14 day follow up after all treatment periods was from 16-Mar-2007 to 10-Dec-2007. First study dosing to last dosing period was from 23-Mar-2007 to 03-Dec-2007.
|
0.00%
0/11 • From consent to 14 day follow up after all treatment periods was from 16-Mar-2007 to 10-Dec-2007. First study dosing to last dosing period was from 23-Mar-2007 to 03-Dec-2007.
|
0.00%
0/11 • From consent to 14 day follow up after all treatment periods was from 16-Mar-2007 to 10-Dec-2007. First study dosing to last dosing period was from 23-Mar-2007 to 03-Dec-2007.
|
|
Nervous system disorders
Tingling
|
0.00%
0/11 • From consent to 14 day follow up after all treatment periods was from 16-Mar-2007 to 10-Dec-2007. First study dosing to last dosing period was from 23-Mar-2007 to 03-Dec-2007.
|
9.1%
1/11 • Number of events 1 • From consent to 14 day follow up after all treatment periods was from 16-Mar-2007 to 10-Dec-2007. First study dosing to last dosing period was from 23-Mar-2007 to 03-Dec-2007.
|
0.00%
0/11 • From consent to 14 day follow up after all treatment periods was from 16-Mar-2007 to 10-Dec-2007. First study dosing to last dosing period was from 23-Mar-2007 to 03-Dec-2007.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER