Trial · NCT00549549
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity | Baseline and Day 2 | The Patient's Pain Intensity in the Index Joint for the prior 24 hours was assessed by completion of the following 5 point scale: My pain over the past 24 hours has been: None (0), Mild (1), Moderate (2), Severe (3), or Extreme (4). |
| Secondary | Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness | Baseline, Day 5, Day 9, and Day 14/Early Termination | Tenderness was assessed on the basis of palpation or passive motion using a 4 point scale with the following ratings: the patient had no tenderness (0), the patient complained of pain (1), the patient complained of pain and winced (2) and the patient complained of pain, winced, and withdrew (3). |
| Secondary | Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling | Baseline, Days 5, 9 and 14/Early Termination | Swelling was assessed using a 4 point scale with the following ratings: none (0), palpable (1), visible (2), and bulging beyond joint margins (3) |
| Secondary | Number of Participants With Redness Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14/Early Termination | Baseline, Day 5, Day 9 and Day 14/Early Termination | Redness was assessed by the physician as present or absent. |
| Secondary | Number of Participants With Warmth Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14 | Baseline, Day 5, Day 9 and Day 14 | Warmth was assessed by the physician as present or absent. |
| Secondary | Change From Baseline in Patient's Assessment of Pain Intensity | Baseline, Day 2 to Day 13 | The Patient's assessment of pain for the prior 24 hours was assessed by completion of the following 5 point scale: My pain over the past 24 hours has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4). |
| Secondary | Change From Baseline in Patient's Assessment of Pain Intensity on Day 1 | Baseline, 2, 4, 8, 12 hours postdose Day 1, Day 2 (24 hours and 32 hours post first dose) | The patient's assessment of pain was assessed by completion of the following 5 point scale: my pain at this time is none (0), mild (1), moderate, (2), severe (3), and extreme (4). |
| Secondary | Change From Baseline in Time Weighted Average of Patient's Assessment of Pain Intensity Over 8, 12, and 24 Hours | Baseline, 8, 12, and 24 hours post first dose | Time weighted average over 8 (TWA-8), 12 (TWA-12) and 24 (TWA-24) hours post first dose of study medication on Day 1. Positive TWA values represent a reduction in pain intensity |
| Secondary | Number of Participants With ≥30% and ≥50% Reduction From Baseline to Day 2 in Patient's Assessment of Pain Intensity | Baseline, Day 2 | The Patient's assessment of pain was assessed by completion of the following 5 point scale: My pain over the past 24 hours has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4). |
| Secondary | Participant's Assessment of Pain Intensity for the Average Pain Intensity at Baseline | Baseline | The participant's assessment of pain was assessed by completion of the following 5 point scale: My pain has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4). |
| Secondary | Percentage Change From Baseline in the Patient's Assessment of Pain Intensity for the Average Pain Intensity on Days 2-4, Days 2-8 and Days 2-13 | Baseline to Day 13 | The participant's assessment of pain was assessed by completion of the following 5 point scale: My change in pain has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4). Average change over days was calculated by taking the change from Baseline to the average Pain Intensity score over the days for each patient. |
| Secondary | Number of Participants With Withdrawal From Treatment Due to Lack of Efficacy | Day 1 to Day 8 | Withdrawal due to lack of efficacy was assessed from Days 1 to 8 |
| Secondary | Participants Global Evaluation of Study Medication Score | Day 9 | The participant rated the study medication that they received during the study by completing the following question: How would you rate the study medication you received for pain? 4=Excellent, 3=Good, 2=Fair, 1=Poor |
| Secondary | Number of Participants With Pre-specified Gastrointestinal (GI) Adverse Events | Baseline to Day 14/Early Termination | The gastrointestinal tolerability was measured by incidence of moderate or severe GI adverse events (nausea, abdominal pain and dyspepsia) |
| Secondary | Number of Participants With Moderate or Severe Central Nervous System (CNS) Adverse Events | Baseline to Day 14/Early Termination | The pre-specfied CNS AEs were headache, nausea, dizziness, vertigo, vomiting and somnolence. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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