Tepilta® Versus Oxetacaine, Antacids and Placebo

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by MEDA Pharma GmbH & Co. KG
Sponsor:
Collaborators:
Trium Analysis Online GmbH
Siro Clinpharm Germany GmbH
Aptiv Solutions GmbH
Accovion GmbH
Information provided by (Responsible Party):
MEDA Pharma GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT01336530
First received: April 1, 2011
Last updated: May 7, 2014
Last verified: May 2014

April 1, 2011
May 7, 2014
April 2011
September 2015   (final data collection date for primary outcome measure)
Time from randomisation to requirement of additional systemic pain medication for oesophagitis (ASPO). [ Time Frame: up to 11 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01336530 on ClinicalTrials.gov Archive Site
  • ASPO: WHO analgesic pain ladder [ Time Frame: up to 11 weeks ] [ Designated as safety issue: No ]
    ASPO = Additional systemic pain medication for oesophagitis
  • Pain intensity recorded on NRS with scores 0-10 [ Time Frame: up to 11 weeks ] [ Designated as safety issue: No ]
    NRS = Numeric Rating Scale
  • Swallowing disorder recorded on NRS with scores 0-10 [ Time Frame: up to 11 weeks ] [ Designated as safety issue: No ]
    NRS = Numeric Rating Scale
  • Adapted CTCAE grade [ Time Frame: up to 11 weeks ] [ Designated as safety issue: No ]

    CTCAE = Common Terminology Criteria for Adverse Events

    Severity of oesophageal symptoms will be evaluated by the investigator according to an adapted CTCAE grading system. In contrast to the original CTCAE classification the adapted version foreseen to be used in this study distinguishes level 2a and 2b.

    2a = symptomatic; altered eating/swallowing; oral supplements indicated; requiring predominantly pureed or soft diet, 2b = symptomatic; altered eating/swallowing; oral supplements indicated; requiring predominantly liquid diet.

  • Incidence of artificial nutrition due to radiation-induced oesophagitis [ Time Frame: up to 11 weeks ] [ Designated as safety issue: No ]
  • Incidence of interruptions of radiation therapy due to radiation-induced oesophagitis [ Time Frame: up to 11 weeks ] [ Designated as safety issue: No ]
  • Duration of pain medication intake after the end of Radiation Therapy [ Time Frame: up to 11 weeks ] [ Designated as safety issue: No ]
  • Loss of body weight [ Time Frame: up to 11 weeks ] [ Designated as safety issue: No ]
  • ASPO: WHO analgesic pain ladder [ Time Frame: up to 11 weeks ] [ Designated as safety issue: No ]
  • Pain intensity recorded on NRS with scores 0-10 [ Time Frame: up to 11 weeks ] [ Designated as safety issue: No ]
  • Swallowing disorder recorded on NRS with scores 0-10 [ Time Frame: up to 11 weeks ] [ Designated as safety issue: No ]
  • Adapted CTCAE grade [ Time Frame: up to 11 weeks ] [ Designated as safety issue: No ]

    Severity of oesophageal symptoms will be evaluated by the investigator according to an adapted CTCAE grading system. In contrast to the original CTCAE classification the adapted version foreseen to be used in this study distinguishes level 2a and 2b.

    2a = symptomatic; altered eating/swallowing; oral supplements indicated; requiring predominantly pureed or soft diet, 2b = symptomatic; altered eating/swallowing; oral supplements indicated; requiring predominantly liquid diet.

  • Incidence of artificial nutrition due to radiation-induced oesophagitis [ Time Frame: up to 11 weeks ] [ Designated as safety issue: No ]
  • Incidence of interruptions of radiation therapy due to radiation-induced oesophagitis [ Time Frame: up to 11 weeks ] [ Designated as safety issue: No ]
  • Duration of pain medication intake after the end of Radiation Therapy [ Time Frame: up to 11 weeks ] [ Designated as safety issue: No ]
  • Loss of body weight [ Time Frame: up to 11 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Tepilta® Versus Oxetacaine, Antacids and Placebo
Clinical Trial to Assess the Efficacy of Fixed Combination Product Tepilta® in the Treatment of Radiation-induced Oesophagitis Compared to Its Active Ingredients Oxetacaine and Antacids, and to Placebo

This is a randomised, double-blind, placebo-controlled, therapeutic confirmatory multicentre trial with 4 parallel treatment groups. The design is adaptive group-sequential with two interim analyses, possible sample size re-estimation after the first or second interim analysis and drop-the-loser approach. The study design was primarily chosen to show superior efficacy of Tepilta® compared to the single components and to placebo. Evaluation of safety is a secondary objective.

Tepilta® Suspension is indicated for treatment of pain in the upper digestive system induced by radiation therapy, in particular for radiation-induced oesophagitis.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Radiation-induced Oesophagitis
  • Drug: oxetacaine, aluminium and magnesium hydroxide
    20mg/10ml oxetacaine, 196mg/10ml magnesium hydroxide, 582mg/10ml aluminium hydroxide. Suspension for oral intake 3-6 times per day for a maximum of 11 weeks.
    Other Name: Tepilta®
  • Drug: oxetacaine
    20mg/10ml oxetacaine. Suspension for oral intake 3-6 times per day for a maximum of 11 weeks.
  • Drug: magnesium and aluminium hydroxide
    196mg/10ml magnesium hydroxide, 582mg/10ml aluminium hydroxide. Suspension for oral intake 3-6 times per day for a maximum of 11 weeks.
    Other Name: Antacids
  • Other: Vehicle
    Placebo suspension for oral intake 3-6 times per day for a maximum of 11 weeks.
  • Experimental: Tepilta®
    Intervention: Drug: oxetacaine, aluminium and magnesium hydroxide
  • Active Comparator: Oxetacaine
    Intervention: Drug: oxetacaine
  • Active Comparator: Antacids
    Intervention: Drug: magnesium and aluminium hydroxide
  • Placebo Comparator: Placebo
    Intervention: Other: Vehicle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
810
November 2015
September 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male or female ≥ 18 years.
  2. Score = 0 on NRS for oesophageal pain.
  3. Radiotherapy (RT) or combined radio-chemotherapy (RCT) of a solid tumour in head/neck/thorax region. A minimum length of 5 cm of the oesophagus must be included in high-dose radiation field.
  4. Duration of RT 5 to 8 weeks.
  5. Single radiation dosage of fractionated RT 1.8 to 2.0 Gy/day, of intensity-modulated RT (IMRT) 1.5 to 2.3 Gy/day, each for 5 days a week (single frequency deviations are allowed presuming that intended duration of RT remains 5 to 8 weeks).
  6. First radiation in the intended radiation area.
  7. Written informed consent.

    Randomisation criteria:

  8. Appearance of oesophageal pain as follows: Score ≥ 2 on Numeric Rating Scale (NRS) for pain during main daily meals is reached at least once.
  9. At least 20 Gy of the dose of radiation therapy in oesophageal area remaining.
  10. Oesophageal symptoms of grade ≤ 2a according to the adapted Common Terminology Criteria for Adverse Events CTCAE.

Exclusion Criteria:

  1. History of allergic reaction to the study medication or its excipients (i.e. aluminium or magnesium hydroxide, oxetacaine, any other ingredient of study medication).
  2. Pregnancy, breast-feeding or planned pregnancy during the study.
  3. Known hypermagnesaemia.
  4. Known hypophosphataemia.
  5. Clinically significant obstipation, as judged by the investigator.
  6. Acute appendicitis.
  7. Total intended radiation dose at lips and the anterior oral cavity > 60% of total intended radiation dose at the swallowing process (pharynx, oesophagus).
  8. Hyper-fractionated RT.
  9. Intended naso-gastral tubes.
  10. Primary tumour of the cranial base, brain, oral cavity, lips, naso-pharynx, para-nasal sinuses.
  11. Known bone metastases.
  12. Reflux oesophagitis 3 months prior to the study.
  13. Continuous systemic pain treatment at the beginning of RT. Systemic pain medication for oesophagitis prior to randomisation must not be taken.
  14. Concomitant treatment with gastric acid inhibitors (such as H2-receptor-blockers, proton inhibitors, bismuth salts or antacids other than those used as study medication), tetracyclines, cinolone derivatives (ciprofloxacin, ofloxacin, enoxacin, norfloxacin), cheno-desoxycholic acid, sodium fluoride, local anaesthetics (other than those used as study medication).
  15. Patients relying on levothyroxine after resection of thyroid carcinoma being hypothyroid and patients relying on levothyroxine due to other reasons not being euthyroid.
  16. Artificial nutrition at the beginning of radiation.
  17. Drug (licit and illicit) or alcohol abuse which would interfere with the patient's proper completion of the study.
  18. Exposure to an investigational product within the last 4 weeks, simultaneous exposure to another investigational product.
  19. Lack of ability or willingness to give informed consent.
  20. Anticipated non-availability for study visits / procedures.
  21. Lack of ability or willingness to keep patient's diary.
  22. Lack of willingness to have personal study related data collected, archived or transmitted according to the protocol.
  23. Vulnerable subjects.
Both
18 Years and older
No
Contact: Melanie Emmeluth, M.Sc. +49 6172 888 ext 01
Germany,   Austria
 
NCT01336530
X-03030-3277, 2009-014441-93
Yes
MEDA Pharma GmbH & Co. KG
MEDA Pharma GmbH & Co. KG
  • Trium Analysis Online GmbH
  • Siro Clinpharm Germany GmbH
  • Aptiv Solutions GmbH
  • Accovion GmbH
Principal Investigator: Frank Bruns, Dr. med. Hannover Medical School
Study Chair: Ursula Petzold, PhD MEDA Pharma GmbH & Co. KG
MEDA Pharma GmbH & Co. KG
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP