None listed
Conditions
Interventions
Group 1 Type of group
valdecoxib 40 mg BID for 6 weeks
Group name:Group 3 Type of group
Placebo BID orally for 6 weeks
Sponsors
PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,
Eligibility
Inclusion criteria
Inclusion criteria: • The patient must have the legal age to grant consent, or be older than that age. • The patient has chronic pain related to cancer or as a result of previous cancer therapy, which is expected to last at least 6 weeks. The main component of pain should be visceral and / or somatic-based nociceptive pain and require daily analgesic medication during the 6-week study period. • The patient must be in a Level II or lower on the WHO analgesic scale. • The patient has pain related to cancer or as a result of a previous oncological therapy whose measurement of the worst intensity is> 2, using the 11-Point Numerical Rating Scale (NRS), in five of the seven days prior to the Visit of Selection. • The patient has an average pain intensity> 2, using the 11-point Numerical Rating Scale (NRS), for 3 consecutive days before the baseline visit. • If you use an opioid combination product, the daily dose in oral morphine equivalents is 50 kg. • The patient presents a Kamofsky Performance Score> 70 at the baseline • The patient has an expectation of life> 6 months from the beginning of the study. • 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 provided written informed consent prior to performing any procedure related to the study.
Exclusion criteria
Exclusion criteria: • Those patients whose pain is classified mainly as neuropathic or of unknown nature. • Those patients whose daily opioid combination requirements in oral morphine equivalents are> 40 mg / day and / or receive a prolonged-release (SR) formulation. • Patients currently participating in a research chemotherapy trial. • Those patients who foresee the initiation of the use of the new chemotherapeutic agent in less than three weeks before the first dose or during the first 2 weeks of the study. • Patients who are using active oncological therapy within two weeks before randomization until week 2 of the study, therapy that could be thought to confuse the evaluation of analgesic efficacy or safety of the study drug. • Those patients who are scheduled to undergo a therapeutic procedure (for example, surgery or biopsy), likely to influence their pain intensity until week 2 of the study. • The reception of radiopharmaceutical treatment or radiotherapy within 4 weeks of randomization, until week 2 of the study. • Initiation of a bisphosphonate treatment within 8 weeks of randomization until week 2 of the study. Patients who have started bisphosphonate therapy> 8 weeks before randomization can continue using bisphosphonates according to the instructions received. • The patient received any 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 this study. • History of esophageal or gastric cancer. • Patients with AIDS or cancers related to AIDS. • Mild to moderate hepatic insufficiency. • 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, and / or creatinine level> 1.5 mg / dl. • 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. • History of significant abuse of alcohol, analgesics, or narcotic substances within six months prior to the Selection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Abbreviated Inventory of Modified Pain (Abbreviated Form), obtained from the weekly telephone interviews throughout the first two weeks of the study. Measure:Average of the worst pain intensity scores obtained weekly during the first two-week period. Timepoints:2 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Abbreviated Inventory of Modified Pain (Abbreviated Form), obtained from the weekly telephone interviews throughout the first two weeks of the study. Measure:Average of the average pain intensity scores (from the BPI) obtained weekly during the first two week period. Timepoints:2 weeks ; Outcome name:where Level II is defined as at least 1 dose of an opiate in 4 of 7 days, or from Level II to Level III, where Level III is defined as> 60 mg of morphine equivalents for 3 consecutive days or abandonment due to pain out of control. Measure:Time to progression and proportion of patients progressing from Level 1 pain to Level 11 for six weeks Timepoints:6 weeks ; Outcome name:Average consumption of daily morphine equivalents throughout the first two weeks of the Treatment Period. Measure:Average consumption of daily morphine equivalents throughout the first two weeks of the Treatment Period. Timepoints:2 weeks ; Outcome name:Average of the composite score of pain interference with the function (obtained from the BPI), evaluated weekly, throughout the first two weeks of the Treatment Period. Measure:Average of the composite score of pain interference with the function Timepoints:2 weeks ; Outcome name:Average of the worst pain intensity, evaluated daily (obtained from the diary), during the first two initial weeks of the Treatment Period. Measure:Average of the worst pain intensity, evaluated daily Timepoints:2 weeks ; Outcome name:Weekly pain relief (obtained from the BPI), evaluated once a week, throughout the first two weeks of the Treatment Period. Measure:Weekly pain relief Timepoints:2 weeks ; Outcome name:Average average intensity of current pain (obtained from the BIS), evaluated once a week, during the first two weeks of the Treatment Period. Measure:Average average intensity of current pain Timepoints:2 weeks ; Outcome name:Global Patient Evaluati | — |
Outcome results
None listed