EN | UA
EN | UA

Help Support

Back

Co-crystal of Tramadol-Celecoxib outperforms Tramadol for pain management after oral surgery

Third molar extraction therapy Third molar extraction therapy
Third molar extraction therapy Third molar extraction therapy

What's new?

Compared to Tramadol alone, the co-crystal of Tramadol-Celecoxib provides better mitigation of moderate-to-severe acute pain following third molar extraction requiring the removal of bone.

In a randomized phase 3 trial (STARDOM1), the co-crystal of Tramadol-Celecoxib (CTC) illustrated better pain alleviation following oral surgery when compared to Tramadol or placebo, with a more favorable benefit-to-risk ratio when compared to Tramadol. This phase 3 multicenter, double-blind trial was conducted to contemplate the effectiveness and safety of CTC compared to Tramadol for moderate-to-severe pain experienced up to 72 hours following elective third molar extraction involving bone removal.

A total of 726 adults were randomly assigned to one of five groups in a ratio of 2:2:2:2:1. These groups received either orally administered CTC twice daily at doses of 100 mg (containing 44 mg of rac-Tramadol hydrochloride and 56 mg of Celecoxib; n = 164), 150 mg (66/84 mg; n = 160), or 200 mg (88/112 mg; n = 160), 100 mg Tramadol four times daily (n = 159), or placebo four times daily (n = 83). Subjects in the CTC groups were also given twice-daily placebo. The full analysis set encompassed all volunteers who underwent randomization.

The sum of pain intensity differences over the first 4 hours (SPID0-4) examined utilizing a visual analog scale (VAS) was the primary outcome ascertained. Key secondary outcomes encompassed the rate of responders attaining at least a 50% drop in pain intensity at 4 hours and the usage of rescue medication. Safety evaluations incorporated monitoring adverse events, lab parameters, and scores on the Opioid-Related Symptom Distress Scale (OR-SDS).

For both primary and key secondary endpoints, all the doses of CTC illustrated superiority over placebo (P < 0.001). Furthermore, CTC outperformed Tramadol in SPID0-4 (with analysis of covariance [ANCOVA] least squares mean differences [95% confidence interval (CI)] of -37.1 [-56.5, -17.6], -40.2 [-59.7, -20.6], and -41.7 [-61.2, -22.2] for 100, 150, and 200 mg CTC, respectively; P < 0.001) and the 4-hour 50% responder rate.

The rates of responders attaining at least a 50% reduction in pain at 4 hours were 32.9% (CTC 100 mg), 33.8% (CTC 150 mg), 40.6% (CTC 200 mg), 20.1% (Tramadol), and 7.2% (placebo). Moreover, the usage of rescue medication was remarkably lower in the 100-mg (P = 0.013) and 200-mg (P = 0.003) CTC groups as opposed to the Tramadol group. In the Tramadol alone arm, the occurrence of adverse events and OR-SDS scores were greatest.

Source:

Advances in Therapy

Article:

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)

Authors:

Richard Langford et al.

Comments (0)

You want to delete this comment? Please mention comment Invalid Text Content Text Content cannot me more than 1000 Something Went Wrong Cancel Confirm Confirm Delete Hide Replies View Replies View Replies ru en ua
Try: