Efficacy And Safety Of Parecoxib 40 mg vs. Ketoprofen 100mg In The Management Of Acute Renal Colic (NAP)
- Conditions
- -N23 Unspecified renal colicUnspecified renal colicN23
- Registration Number
- PER-036-07
- Lead Sponsor
- PFIZER S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>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.<br>Measure:Mean difference in pain intensity (mPID30min).<br>Timepoints:At 30 minutes.<br>
- Secondary Outcome Measures
Name Time Method