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Last Updated: September 26, 2020

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CLINICAL TRIALS PROFILE FOR ABSTRAL

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All Clinical Trials for ABSTRAL

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01315886 Conversion From Fast Acting Oral Opioids to Abstral® Suspended Orexo AB Phase 4 2011-02-01 The purpose of this study is to evaluate safety and efficacy when using a novel dose conversion strategy to switch from immediate release oral opioids to sublingual (SL) fentanyl (Abstral) for treatment of breakthrough cancer pain (BTcP).
NCT01604187 Procedural Pain Treatment With Transmucosal Sublingual Fentanyl Tablet in Colonoscopy Patients Recruiting Turku University Hospital Phase 4 2012-04-01 Colonoscopy is generally considered an invasive procedure that causes remarkable pain to the patient. The pain associated with the procedure is not caused by the insertion of the scope but from inflating of the colon in order to do the inspection. It has been shown that colonoscopy can be performed successfully without sedation (Leung, 2010), but many patients feel discomfort during the procedure. Factors predicting a painful colonoscopy are female-gender, degree of patient nervousness and the technical difficulty of the colonoscopy (Ylinen et al. 2009). Also age under 40, previous abdominal surgery and use of sedation are associated with painful colonoscopy ( Seip et al. 2009). Most often sedation and/or analgesia are achieved by administering a benzodiazepine or a combination of a benzodiazepine and an opioid (Fanti et al. 2009, Maskelar et al. 2009,), dexmedetomidine (Dere et al. 2009) or by using non-pharmacologic methods (Amer-Cuenca et al. 2011). Tramadol as monotherapy did not significantly decrease pain intensity or endoscopist's evaluation of colonoscopy (Grossi et al. 2004). Currently, intravenous midazolam is the drug used most commonly to introduce some sedation for colonoscopy. Intravenous sedation definitely increases the cost of procedure; drug administration, need for pulse oximetry monitoring and the need for follow-up after the procedure make colonoscopy sometimes expensive and troublesome. It has also been shown, that low-dose midazolam neither relieves discomfort nor makes patients forget it (Elphick et al. 2009). Fentanyl is a short-acting opioid widely used in anesthesia management. Transmucosal sublingual formulation of fentanyl has been developed to further improve the management of pain. When administered as a sublingual fast-dissolving tablet (Abstral®) that is placed under the tongue, the effects is fast and predictable. Its active ingredient is absorbed by the body through the mucous membrane. After administration of buccal fentanyl maximum plasma drug concentration was measured after 25 minutes (Darwish et al. 2011). Plasma fentanyl concentrations versus time following buccal and sublingual administration are very similar (Darwish et al. 2008). Abstral® sublingual tablets should be administered directly under the tongue at the deepest part. Sublingual administration is an easy and non-invasive method of pain treatment for the patient coming to colonoscopy done as an office based procedure. Other advantages compared to invasive methods are improved comfort of patients and no need for intravenous access because of pain relief. Before, it has been used in the management of breakthrough pain in cancer patients. Sublingual fentanyl is shown to be effective and well-tolerated for the treatment of breakthrough cancer pain (Uberall et al. 2011). The use of transmucosal tablet for colonoscopy patients is a quite new approach.
NCT01936636 Observational Registry Study of Quality of Life When Treating BTcP With Abstral Completed Galena Biopharma, Inc. N/A 2013-10-01 This Observational Registry study is designed to collect self-reported Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) Access program-enrolled patient experience with breakthrough cancer pain (BTcP) as a result of treatment with Abstral® through the use of Quality of Life and pain measurement tools administered via questionnaire.
NCT03080324 Sublingual Versus Endovenous Fentanyl for Pain Treatment in Trauma Patients in the Emergency Room Active, not recruiting Azienda Sanitaria dell'Alto Adige Phase 4 2016-12-01 The purpose of this study is to determine the non-inferiority of the efficacy of sublingual given fentanyl versus endovenous given fentanyl for patients in the emergency departement.
NCT03080350 Sublingual Versus Endovenous Fentanyl for the Prehospital Analgesia in Patients With Limb Trauma on the Slope Active, not recruiting Institute of Mountain Emergency Medicine Phase 4 2017-01-01 The purpose of this study is to determine the non-inferiority of the efficacy for prehospital analgesia of sublingual administered fentanyl versus endovenous administered fentanyl for patients with limb trauma on the slope
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ABSTRAL

Condition Name

Condition Name for ABSTRAL
Intervention Trials
Pain 2
Acute Pain Due to Trauma 2
Quality of Life 1
Colonoscopy 1
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Condition MeSH

Condition MeSH for ABSTRAL
Intervention Trials
Wounds and Injuries 2
Acute Pain 2
Breakthrough Pain 1
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Clinical Trial Locations for ABSTRAL

Trials by Country

Trials by Country for ABSTRAL
Location Trials
United States 17
Italy 2
Finland 1
Sweden 1
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Trials by US State

Trials by US State for ABSTRAL
Location Trials
Oklahoma 1
California 1
Rhode Island 1
Tennessee 1
Texas 1
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Clinical Trial Progress for ABSTRAL

Clinical Trial Phase

Clinical Trial Phase for ABSTRAL
Clinical Trial Phase Trials
Phase 4 4
N/A 1
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Clinical Trial Status

Clinical Trial Status for ABSTRAL
Clinical Trial Phase Trials
Active, not recruiting 2
Recruiting 1
Suspended 1
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Clinical Trial Sponsors for ABSTRAL

Sponsor Name

Sponsor Name for ABSTRAL
Sponsor Trials
Azienda Sanitaria dell'Alto Adige 2
Galena Biopharma, Inc. 1
Turku University Hospital 1
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Sponsor Type

Sponsor Type for ABSTRAL
Sponsor Trials
Other 4
Industry 2
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