Co-crystal of Tramadol-Celecoxib Versus Tramadol or Placebo for Acute Moderate-to-Severe Pain After Oral Surgery: Randomized, Double-Blind, Phase 3 Trial (STARDOM1).

Introduction: Co-crystal of tramadol-celecoxib (CTC) is the first analgesic co-crystal for acute pain. This completed phase 3 multicenter, double-blind trial assessed the efficacy and safety/tolerability of CTC in comparison with that of tramadol in the setting of moderate-to-severe pain up to 72 h after elective third molar extraction requiring bone removal.

Methods: Adults (n = 726) were assigned randomly to five groups (2:2:2:2:1): orally administered twice-daily CTC 100 mg (44 mg rac-tramadol hydrochloride/56 mg celecoxib; n = 164), 150 mg (66/84 mg; n = 160) or 200 mg (88/112 mg; n = 160); tramadol 100 mg four times daily (n = 159); or placebo four times daily (n = 83).

Osteomyelitis of the jaw: resistance to clindamycin in patients with prior antibiotics exposure.

The purpose of this paper was to review our clinical experience in patients with osteomyelitis (OM) of the jaw, focusing on aspects of antimicrobial resistance. A retrospective review of the medical records of adult patients with jaw OM was carried out. Among 46 cases of jaw OM, the cause was odontogenic in 32 (seven had recent dental implants and four bisphosphonate osteonecrosis), postoperative/post-traumatic in eight, and secondary to osteoradionecrosis in six.

Preoperative induction chemotherapy followed by concurrent chemoradiotherapy in advanced carcinoma of the oral cavity and oropharynx.

Background: Combined modality therapy plays a central role in the management of advanced head and neck tumors. The objective of our Phase II study was to determine the feasibility, toxicity, and clinical and pathologic response of preoperative induction chemotherapy, followed by concurrent chemoradiotherapy in patients with Stage III or IV squamous cell carcinoma according to the American Joint Committee on Cancer Staging of the oral cavity and oropharynx with no distant metastases.

Methods: After staging, 62 patients with locally advanced carcinoma of the oral cavity and oropharynx were treated preoperatively with chemotherapy (1 cycle of cisplatin and 5-fluorouracil [P-5FU]) followed by concurrent chemoradiotherapy (3 cycles of P-5FU combined with radiotherapy, 60 grays [Gy] given in 33 fractions of 1.

Preoperative simultaneous chemoradiotherapy in locally advanced cancer of the oral cavity and oropharynx.

Combined chemoradiotherapy (CT/RT) treatments appear to yield better results for advanced tumours of the head and neck than do conventional therapies. In the present study, CT/RT was used preoperatively in unresectable tumors of the oral cavity and oropharynx. Forty patients were entered prospectively into a phase II study.