None listed
Conditions
Interventions
Group 1 Type of group
Valdecoxib 40 mg twice a day for 12 weeks
Group name:Group 2 Type of group
Placebo twice a day for 12 weeks
Sponsors
PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,
Eligibility
Inclusion criteria
Inclusion criteria: • The patient suffers from chronic pain related to cancer or as a result of previous cancer therapy, which is assumed to last at least 90 days. The main component of this pain should be visceral pain and / or nociceptive somatic base. • The patient required daily opioid analgesic medication (> 5 days per week) for at least two weeks prior to entering the study, and is expected to require daily opioid medication throughout the course of the study. • The patient met the criteria for pain intensity, total daily opioid use, and adverse events, established for the Stabilization Phase. • The patient must have the legal age to grant consent, or be older than that age. • Weight> 50 kg. • The female patient is postmenopausal, surgically sterile, or uses an adequate method of contraception, is not breastfeeding or nursing a baby, and presented a negative pregnancy test in serum within 14 days before starting the study. • The patient presents a Kamofsky Performance Score> 60 at the baseline • The patient has an expectation of life> 4 months from the beginning of the study. • The patient provided written informed consent before carrying out any procedure related to the study.
Exclusion criteria
Exclusion criteria: • Those patients whose pain is classified mainly as neuropathic or of unknown nature. • The patient received an agent under investigation within 30 days prior to the first dose of the study medication, or is scheduled to receive a drug under investigation other than valdecoxib during the course of the study. • Those patients who are currently participating in a research chemotherapy trial. • Those patients in whom the initiation of the use of a new chemotherapeutic agent is expected in less than three weeks before the first dose of the study medication until Day 42 of the same. • Patients who are using active oncology therapy within two weeks of receiving the first dose of the study drug (study entry) until Day 42 of the study, which is expected to confuse the evaluation of efficacy or safety analgesic • Those patients who are scheduled to undergo a therapeutic procedure (for example, surgery or biopsy), with the possibility of influencing their pain intensity until Day 42 of the study. • The reception of radiopharmaceutical treatment or radiotherapy within 4 weeks prior to receiving the first dose of the study drug, until Day 42 thereof. • History of cancer of the esophagus or gastric. • Patients with AIDS or with cancers related to AIDS. • Known significant hepatic insufficiency (Ciase B or C of Child-Pugh). • Those patients who have been diagnosed or have received treatment for esophageal, gastric, pyloric or duodenal channel ulceration, within 30 days prior to receiving the first dose of the study medication. • Known renal insufficiency, creatinine level> 1.5 mg / dl, blood urea nitrogen [BUN]> 1.5, the upper limit of normal, or a creatinine clearance, if known, <50 ml / minute. • Platelet count <40,000, or impaired platelet function. • Presence or history of a disease or unstable condition that, in the opinion of the investigator, would exclude the participation of the patient in the trial. • Inability to take tablets or tolerate oral medication. • Intractable nausea and vomiting. • History of hypersensitivity to cyclooxygenase inhibitors (DAINEs, specific inhibitors of COX-2) or opioids. • The patient will begin the use of bisphosphonates within 8 weeks of entering the study, until Day 42 of the same. Patients who have started bisphosphonate therapy 8 weeks before the first dose of the study drug can continue using bisphosphonates as indicated. • Concomitant use of antidepressants, antiepileptic drugs, corticosteroids or antihistamines used as analgesic aids, unless such therapy has been initiated in a period greater than 2 weeks before the first dose of the study drug. • Scheduled use of any analgesic, specific inhibitors of COX-2, or DAINEs different to that established by the protocol during the study period. (The use of acetaminophen <2 grams / day for 2 days or less per week is allowed). • Physical / mental inability to answer questions and comply with the treatment protocol. • History of significant abuse of alcohol, analgesics, or narcotic substances within six months prior to the Selection. • The patient was admitted prior to the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:of the BPI, evaluated once a week. Measure:Average of the worst pain intensity Timepoints:6 weeks ; Outcome name:obtained from the BPI, evaluated once a week. Measure:Average score composed of pain interference with function Timepoints:6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Average daily total morphine consumption, every week, throughout the first six weeks and during the 12 weeks of the Treatment Period Measure:Average daily total morphine consumption Timepoints:12 weeks ; Outcome name:Average of the worst pain intensity (obtained from the BPI), evaluated once a week, throughout the 12 weeks of the Treatment Period. Measure:Average of the worst pain intensity Timepoints:12 weeks ; Outcome name:Average of the composite score of pain interference with the function (obtained from the BPI), evaluated once a week, throughout the 12 weeks of the Treatment Period. Measure:Average of the composite score of pain interference with the function Timepoints:12 weeks ; Outcome name:Average average intensity of daily pain (obtained from the BPI), evaluated once a week, throughout the first six weeks and during the 12 weeks of the Treatment Period. Measure:Average average intensity of daily pain Timepoints:12 weeks ; Outcome name:Average of the worst intensity of the daily pain (obtained from the BPI), averaged weekly, during the first six weeks and during the 12 weeks of the Treatment Period. Measure:Average of the worst intensity of the daily pain Timepoints:12 weeks ; Outcome name:Average daily pain intensity average (obtained from the BPI), averaged weekly, throughout the first six weeks and during the 12 weeks of the Treatment Period. Measure:Average daily pain intensity average Timepoints:12 weeks ; Outcome name:obtained from the BIS, averaged over the first six weeks, and during the 12 weeks of the Treatment Period. Measure:Relief of weekly pain Timepoints:12 weeks ; Outcome name:Clinical evaluation Measure:Global Patient Assessment of Study Medication Timepoints:12 weeks ; Outcome name:it will be analyzed by a survival analysis method. The estimate of the mean time and the 95% confidence intervals for the mean t | — |
Outcome results
None listed