A Comparative Investigation of Standard Of Care (SOC) and Episil® in Combination Versus SOC Alone on Oral Mucositis (episil(R))

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Camurus AB
ClinicalTrials.gov Identifier:
NCT01684566
First received: September 11, 2012
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

To compare the performance of standard of care (SOC) + episil® versus SOC alone on oral mucositis in patients receiving conditioning treatment for hematopoietic stem cell transplantation (HSCT). The primary variable will be the area under the curve (AUC) of oral mucositis scores defined by the WHO oral toxicity scale assessed daily by the investigator over the 28-day study period.


Condition Intervention
Oral Mucositis
Device: episil(R)
Other: Oral hygiene procedures

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Multicenter, Open-label, Parallel Group Investigation to Compare the Performance of Standard Of Care (SOC) and Episil® in Combination Versus SOC Alone on Oral Mucositis in Patients Receiving Conditioning Treatment for Hematopoietic Stem Cell Transplantation

Resource links provided by NLM:


Further study details as provided by Camurus AB:

Primary Outcome Measures:
  • Disease (oral mucositis) severity score [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    The area under the curve (AUC) of oral mucositis scores defined by the WHO oral toxicity scale assessed daily by the investigator over the 28-day study period.


Enrollment: 116
Study Start Date: February 2013
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Standard-Of-Care + episil(R)
Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed
Device: episil(R) Other: Oral hygiene procedures
Standard-Of-Care
Oral hygiene procedures
Other: Oral hygiene procedures

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Is at least 18 years of age.
  2. Has a confirmed diagnosis for which he/she is scheduled for hematopoietic stem cell transplantation (HSCT) of either type of transplant (autologous or allogeneic).
  3. Is due to undergo treatment with myeloablative conditioning (radiation-based or non radiation based) before HSCT.

Exclusion Criteria:

  1. Will undergo reduced intensity conditioning before HSCT.
  2. Has got known allergy to any ingredient in the study product or to peanuts, peppermint oil, or soya.
  3. Is pregnant or breast feeding.
  4. Has any other concurrent medical condition that, in the opinion of the investigator, would increase the risk to the patient, compromise evaluation of the investigational device, or interfere with the conduct of the study.
  5. Has an unstable condition (eg, a psychiatric disorder, a recent history of substance abuse) or is otherwise thought to be unreliable or incapable of complying with the study requirements.
  6. Is undergoing treatment with parenteral opioids at enrolment.
  7. Uses treatments that promote mucosal healing (eg, palifermin).
  8. Uses electrolyte mouthwashes (eg, Caphosol®) or other topical oral treatments (eg, Tantum Verde® (benzydamine), Gelclair®, Fungicidin (nystatin)).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01684566

Locations
Sweden
Karin Garming-Legert
Stockholm, Huddinge, Sweden, 141 04
Sponsors and Collaborators
Camurus AB
Investigators
Principal Investigator: Karin Garming-Legert, D.D.S., Ph.D. Karolinska Institutet
  More Information

No publications provided

Responsible Party: Camurus AB
ClinicalTrials.gov Identifier: NCT01684566     History of Changes
Other Study ID Numbers: HS-10-396
Study First Received: September 11, 2012
Last Updated: November 6, 2013
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Stomatitis
Mucositis
Mouth Diseases
Stomatognathic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 10, 2014