Trial reportDrugs in R&D2018
Co-crystal of Tramadol-Celecoxib in Patients with Moderate to Severe Acute Post-surgical Oral Pain: A Dose-Finding, Randomised, Double-Blind, Placebo- and Active-Controlled, Multicentre, Phase II Trial.
Trial report in Drugs in R&D, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed, 45 citations in OpenAlex.
- 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).Advances in therapy · 2024Trial
- Celecoxib-tramadol co-crystal in patients with moderate-to-severe pain following bunionectomy with osteotomy: A phase 3, randomized, double-blind, factorial, active- and placebo-controlled trial.Pain practice : the official journal of World Institute of Pain · 2023Trial
- Efficacy and safety of co-crystal of tramadol-celecoxib (CTC) in acute moderate-to-severe pain after abdominal hysterectomy: A randomized, double-blind, phase 3 trial (STARDOM2).European journal of pain (London, England) · 2022Trial
- Pharmacokinetics of Tramadol and Celecoxib in Japanese and Caucasian Subjects Following Administration of Co-Crystal of Tramadol-Celecoxib (CTC): A Randomised, Open-Label Study.European journal of drug metabolism and pharmacokinetics · 2019Trial
- The Effect of Food on Tramadol and Celecoxib Bioavailability Following Oral Administration of Co-Crystal of Tramadol-Celecoxib (CTC): A Randomised, Open-Label, Single-Dose, Crossover Study in Healthy Volunteers.Clinical drug investigation · 2018Trial
- Efficacy and Safety of a Fixed-Dose Combination of Etoricoxib-Tramadol Biphasic Tablet in Moderate-to-Severe Acute Pain: A Randomized, Double-Blind, Parallel-Group, Active-Controlled Trial.Journal of clinical medicine · 2025Article
- Multimodal Analgesia Approach in Acute Low Back Pain Management: A Phase III Study of a Novel Analgesic Combination of Etoricoxib/Tramadol.Pain and therapy · 2024Article
- Combination Drug Therapy for the Management of Chronic Neuropathic Pain.Biomolecules · 2023Review
- Eco-friendly simultaneous multi-spectrophotometric estimation of the newly approved drug combination of celecoxib and tramadol hydrochloride tablets in its dosage form.Scientific reports · 2023Article
- Cocrystals by Design: A Rational Coformer Selection Approach for Tackling the API Problems.Pharmaceutics · 2023Review
- Combination Therapy for Neuropathic Pain: A Review of Recent Evidence.Journal of clinical medicine · 2021Review
- Challenges and Progress in Nonsteroidal Anti-Inflammatory Drugs Co-Crystal Development.Molecules (Basel, Switzerland) · 2021Review
- Tramadol/Dexketoprofen Analgesic Efficacy Compared with Tramadol/Paracetamol in Moderate to Severe Postoperative Acute Pain: Subgroup Analysis of a Randomized, Double-Blind, Parallel Group Trial-DAVID Study.Pain and therapy · 2021Article
- Challenges and opportunities of pharmaceutical cocrystals: a focused review on non-steroidal anti-inflammatory drugs.RSC medicinal chemistry · 2021Review
- Cocrystal of Apixaban-Quercetin: Improving Solubility and Bioavailability of Drug Combination of Two Poorly Soluble Drugs.Molecules (Basel, Switzerland) · 2021Article
- Drug-drug cocrystals: Opportunities and challenges.Asian journal of pharmaceutical sciences · 2021Review
- New Cocrystals of Antipsychotic Drug Aripiprazole: Decreasing the Dissolution through Cocrystallization.Molecules (Basel, Switzerland) · 2021Article
- Revisiting Tramadol: A Multi-Modal Agent for Pain Management.CNS drugs · 2019Review
- Co-crystals as a new approach to multimodal analgesia and the treatment of pain.Journal of pain research · 2019Article
- Celecoxib-tramadol co-crystal: Efficacy in acute postoperative pain.Indian journal of pharmacologyArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 7 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCo-crystal of tramadol-celecoxib (CTC), containing equimolar quantities of the active pharmaceutical ingredients (APIs) tramadol and celecoxib (100 mg CTC = 44 mg rac-tramadol hydrochloride and 56 mg celecoxib), is a novel API-API co-crystal for the treatment of pain. We aimed to establish the effective dose of CTC for treating acute pain following oral surgery.
methodsA dose-finding, double-blind, randomised, placebo- and active-controlled, multicentre (nine Spanish hospitals), phase II study (EudraCT number: 2011-002778-21) was performed in male and female patients aged ≥ 18 years experiencing moderate to severe pain following extraction of two or more impacted third molars requiring bone removal. Eligible patients were randomised via a computer-generated list to receive one of six single-dose treatments (CTC 50, 100, 150, 200 mg; tramadol 100 mg; and placebo). The primary efficacy endpoint was the sum of pain intensity difference (SPID) over 8 h assessed in the per-protocol population.
resultsBetween 10 February 2012 and 13 February 2013, 334 patients were randomised and received study treatment: 50 mg (n = 55), 100 mg (n = 53), 150 mg (n = 57), or 200 mg (n = 57) of CTC, 100 mg tramadol (n = 58), or placebo (n = 54). CTC 100, 150, and 200 mg showed significantly higher efficacy compared with placebo and/or tramadol in all measures: SPID (0-8 h) (mean [standard deviation]): - 90 (234), - 139 (227), - 173 (224), 71 (213), and 22 (228), respectively. The proportion of patients experiencing treatment-emergent adverse events was lower in the 50 (12.7% [n = 7]), 100 (11.3% [n = 6]), and 150 (15.8% [n = 9]) mg CTC groups, and similar in the 200 mg (29.8% [n = 17]) CTC group, compared with the tramadol group (29.3% [n = 17]), with nausea, dizziness, and vomiting the most frequent events.
conclusionSignificant improvement in the benefit-risk ratio was observed for CTC (doses ≥ 100 mg) over tramadol and placebo in the treatment of acute pain following oral surgery.
fundingLaboratorios del Dr. Esteve, S.A.U.
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