None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with Parecoxib, powder, at a dose of 40 mg, IV, single dose.
Group name:GROUP 2 Type of group
This group will be treated with Ketoprofen, powder, at a dose of 40 mg, IV, single dose.
Sponsors
PFIZER S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients, of any ethnic origin, with ages between 18 and 65 years. 2. The patient has a diagnosis of renal colic with moderate to severe pain. 3. The patient arrives with a pain intensity score at the baseline of 100 mm on the visual analogue scale of> 50 mm and on a categorical scale of moderate to severe pain intensity. 4. The patient agrees to remain in the facility after completing the evaluations required by the pain and safety protocol, at least 2 hours after the administration of the first dose of study medication. 5. If a woman, the patient must be post-menopausal, sterile surgically, or must be using an adequate contraceptive method. Should not be breastfeeding and the urine pregnancy test should be negative before screening the study medication. 6. The patient weighs between 50 and 140 kg (110 to 309 pounds). 7. The patient signs the informed consent document in writing before entering this study.
Exclusion criteria
Exclusion criteria: 1. The patient has significant renal or hepatic conditions. 2. The patient has an acute pain different from renal colic. 3. The patient received a renal allograft. 4. The patient is receiving treatment for a urinary tract infection (UTI), pyelonephritis, or for the clinical suspicion of such an infection. 5. The patient currently receives anticoagulants. 6. The patient has a fever and / or an infection other than a proximal UTI without obstruction or pyelonephrosis. 7. The patient has a history of active peptic ulcer, active dyspepsia, gastrointestinal bleeding or esophageal, gastric or duodenal ulcer during the month prior to the screening evaluation. 8. The patient has a known history of abuse of alcoholic, analgesic or narcotic beverages during the month prior to the screening evaluation. 9. The patient has a history of clinically significant hypersensitivity to any NSAID drug, cyclooxygenase inhibitor, analgesic or sulfa that is cross-sensitive with the medications used in this study. 10. The patient has a history of kidney disease during the last six months prior to randomization. 11. The patient has a history of uncontrolled chronic disease that is a contraindication for participation in the study or that could confuse the interpretation of the results. 12. The patient has some cognitive deficiency that prevents him from participating in the study or comply with the procedures required by the protocol. 13. A chronic pain condition that requires chronic treatment and / or that could affect pain assessments or the response to treatment. 14. The patient is considered to have a clinically significant volume depletion. 15. The patient used analgesics or other agents during the four hours prior to the procedure. 16. During the previous year, the patient was diagnosed or received treatment or is not in remission of any malignancy. 17. Subjects with a history of established ischemic heart disease as well as subjects with a previous revascularization procedure. 18. The patient received a medication under investigation during the past 30 days. 19. The patient previously participated in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The mPID30min is calculated mathematically, based on the visual analogue scale 30 minutes after the dose of the drug and the length of the interval. Measure:Mean difference in pain intensity (mPID30min). Timepoints:At 30 minutes. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Criterion 1: The mPID120min, is calculated mathematically, based on the visual analogue scale 120 minutes after the dose of the drug and the length of the interval. Criterion 2: Visual analog scale from 0 to 100. Criterion 3: Subtraction of the score on the visual analogue scale for pain intensity in the baseline minus the scores of the visual analogue scale at each point of time after the dose. Criteria 4, 5 and 6: Pain relief scale of 0 (No relief) - 4 (Complete relief). Criterion 7: Categorical scale measured by the patient of 4 points out of 1 (Bad) - 4) (Excellent). Criterion 8: Categorical scale measured by the doctor of 4 points out of 1 (Bad) - 4) (Excellent). Criterion 9: Measurement of time from randomization to the need for a rescue medication. Measure:Secondary efficacy: 1) Mean difference in pain intensity 120 minutes after the first dose of study medication (mPID120min). 2) Visual analog scale score for specific pain intensity. 3) Difference in the intensity of specific pain over time (PID). 4) Sum of the pain relief scores weighted according to the time interval, during the first 2 hours after the first dose (TOTPAR2). 5) Pain relief (PR) at all time points after the dose. 6) Proportion of patients with an improvement of at least one degree in pain relief (PR). 7) Overall evaluation of the patient about the study medication. 8) Overall assessment of the doctor about the study medication. 9) Time until the use of rescue medicines. Timepoints:Criteria 1, 4 and 9: At 120 minutes. Criteria 2, 3 and 5: At 15, 30, 45, 60, 90 and 120 minutes Criterion 6: At 30 minutes. Criterion 7 and 8: At 30 and 120 minutes. ; Outcome name:Criterion 1: Determination of the percentage of patients who discontinue treatment. Criterion 2: Clinical evaluation of any undesirable medical experience that occurs in a subject to whom the study medication was administered. Criterion 3: Evaluation of blood pre | — |
Countries
Brazil, Chile, Costa Rica, Ecuador, Honduras, Peru
Contacts
Public ContactLuis Zegarra
PFIZER S.A.
Outcome results
None listed