CLINICAL TRIALS PROFILE FOR CELECOXIB; TRAMADOL HYDROCHLORIDE
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All Clinical Trials for Celecoxib; Tramadol Hydrochloride
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00290901 ↗ | Celebrex vs Tramadol in the Treatment of Chronic Lower Back Pain. | Completed | Pfizer | Phase 4 | 2006-03-01 | This study investigates if Celebrex is as effective as tramadol hydrochloride (Ultram) for patients with chronic low back pain, when administered over a 6-week period. |
| NCT00290901 ↗ | Celebrex vs Tramadol in the Treatment of Chronic Lower Back Pain. | Completed | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Phase 4 | 2006-03-01 | This study investigates if Celebrex is as effective as tramadol hydrochloride (Ultram) for patients with chronic low back pain, when administered over a 6-week period. |
| NCT00348452 ↗ | A Study Comparing the Effectiveness and Safety of Extended Release Tramadol HCl at 100 mg, 200 mg and 300 mg Doses to Placebo for the Treatment of Moderate to Severe Pain Due to Osteoarthritis (OA) | Completed | Bausch Health Americas, Inc. | Phase 3 | 2002-09-01 | The purpose of this study is to compare the analgesic efficacy and safety of tramadol HCl ER 100 mg, 200 mg and 300 mg once a day (QD), with placebo in patients with moderate to severe pain due to OA. For the purposes of this study, celecoxib will serve as a positive control to validate the sensitivity of the model. The study hypothesis is that tramadol HCl ER is safe and effective in the treatment of moderate to severe pain due to OA. |
| NCT00348452 ↗ | A Study Comparing the Effectiveness and Safety of Extended Release Tramadol HCl at 100 mg, 200 mg and 300 mg Doses to Placebo for the Treatment of Moderate to Severe Pain Due to Osteoarthritis (OA) | Completed | Valeant Pharmaceuticals International, Inc. | Phase 3 | 2002-09-01 | The purpose of this study is to compare the analgesic efficacy and safety of tramadol HCl ER 100 mg, 200 mg and 300 mg once a day (QD), with placebo in patients with moderate to severe pain due to OA. For the purposes of this study, celecoxib will serve as a positive control to validate the sensitivity of the model. The study hypothesis is that tramadol HCl ER is safe and effective in the treatment of moderate to severe pain due to OA. |
| NCT00662558 ↗ | A Six Week Study Of The Pain Relieving Effects Of Celecoxib 200 Mg Twice Daily Compared To Tramadol 50 Mg Four Times Daily In Patients With Chronic Low Back Pain | Completed | Pfizer | Phase 3 | 2008-01-01 | To compare the analgesic effectiveness of celecoxib and tramadol in subjects with Chronic Low Back Pain measured by the Numerical Rating Scale (NRS-Pain) at Week 6 |
| NCT00662558 ↗ | A Six Week Study Of The Pain Relieving Effects Of Celecoxib 200 Mg Twice Daily Compared To Tramadol 50 Mg Four Times Daily In Patients With Chronic Low Back Pain | Completed | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Phase 3 | 2008-01-01 | To compare the analgesic effectiveness of celecoxib and tramadol in subjects with Chronic Low Back Pain measured by the Numerical Rating Scale (NRS-Pain) at Week 6 |
| NCT00733421 ↗ | The Effect of Anti-inflammatory Analgesics on Pain Following Hallux Valgus Surgery | Completed | Karolinska Institutet | Phase 4 | 2008-10-01 | The effects of none-steroidal anti-inflammatory drugs (NSAIDs) and selective cyclooxygenase inhibitors (Coxibs) on the formation of bone and fracture healing have been a matter of debate since long. There is, however, limited data in humans and further prospective randomised studies are warranted. Ekman et al studied in a prospective randomised double blind study the effects of celecoxib, a selective cox-II-inhibitor, on pain and bone healing following spine surgery. They found significant effects on reduction of pain and need for opioid analgesics postoperatively but could see no negative effects the numbers of "none-unions" at a 1-year follow up 3. In a similar prospective randomised double-blind study design significant effects in reduction of pain and need for rescue analgesia was seen from the use of celecoxib in the perioperative multi-modal pain strategy for cruciate-ligament reconstruction and no negative effects could bee seen on six month follow-up of the strength of the reconstructed ligament. The aim of the present study is to further study the effects of the perioperative use of etoricoxib, a selective cox-II-inhibitor (Coxibs), in a prospective randomised double-blind study on bone healing, pain and need for rescue analgesia in patients undergoing elective Hallux Valgus surgery with a standardised surgical technique including an osteotomy of metatarsale I and excision of exostosis. Study population 100 American Society of Anesthesiology (ASA) physiological status1-2 patients scheduled for elective hallux valgus (HV) surgery The patients are going to be randomised into 2 groups, 50 patients in each; 1. etoricoxib 90 mg once daily x 5 2. tramadol 100 mg twice daily x 5 First line rescue medication t. paracetamol 1 gr up to 4 gram daily Second line rescue t. oxycodone 10 mg Primary study variables: - X-ray evaluation (computer tomography (CT)-investigation) of bone healing assessed a CT-scan modelling of the osteotomy at twelve weeks after surgery - Number of patients requiring rescue medication - Patient assessment using "brief pain inventory" 24 hours and 2 weeks after surgery Secondary study variables are; - Visual Analogue Scale (VAS) grading Day 1-7 - Compliance to base medication - Need for rescue analgesia Day 1-7 - Adverse Effects - Experience of any emetic symptoms - Experience of any gastrointestinal symptoms - Satisfaction with pain medication Day 20 - Wound dressing Day 20 - Clinical evaluation 17 weeks, final assessment |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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