Trial document




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  DRKS00004909

Trial Description

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Title

Side effects of Tramadol and Tilidine in Cancer Pain Patients – A prospective randomized double blinded clinical trial

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Trial Acronym

TiTaN

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Usually cancer pain is treated according to the three-step WHO pain ladder. Opioids are an import component of this pain ladder. The study drugs tilidine and tramadol are ranked among the mild opioids. Since decades both drugs are approved and commonly used in clinical practice. However both have been used randomly for the treatment of cancer pain for there are little studies comparing and quantifying effects and adverse reactions of both drugs directly. This is what our study is aiming for. Especially the occurrence of sickness, nausea and vomiting shall be compared. Furthermore other side effects and the analgesic effects of tilidine and tramadol are checked against each other.
Study objective is to find the drug with less adverse effects to give an informed therapy recommendation.

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Brief Summary in Scientific Language

The study is ment to compare the side effects of tilidine and tramadol in the treatment of cancer pain. Objective is to find the drug with the better side effects profile.
Tilidine and tramadol have been used in clinical practice since the 1970s. But there are little studies comparing effects and adverse reactions of both drugs.
Anyhow we expect clinical relevant differences - particularly regarding the side effect of sickness, nausea and vomiting.
Therefor two hypotheses are established: 1) There is a difference between tilidine and tramadol regarding their nauseating and vomiting effects. 2) Tilidine and Tramadol show further differences in their side effects profile as well as in their analgesic effects.

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Organizational Data

  •   DRKS00004909
  •   2013/05/13
  •   [---]*
  •   yes
  •   Approved
  •   20/13, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   cancer pain, opioid specific side effects
  •   T88.7 -  Unspecified adverse effect of drug or medicament
  •   R52.9 -  Pain, unspecified
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Interventions/Observational Groups

  •   Valoron (tilidine/naloxone), 2x 100/8mg/day p.o. (prolonged-release tablet), for 4 days
  •   Tramadol (tramadol), 2x 100mg/day p.o. (prolonged-release tablet), for 4 days
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   No
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Primary Outcome

nausea on a numeric rating scale from 0-10, daily documented per questionnaire for probands and investigators, over a period of 4 days

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Secondary Outcome

other side effecs on a numeric rating scale from 0-10, documented daily per questionnaire for probands and investigators, over a period of 4 days
pain on a numeric rating scale from 0-10, documented daily per questionnaire for probands and investigators, over a period of 4 days

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/05/13
  •   150
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

cancer pain patients with moderate to severe pain, age > 18 years, sufficient mental, physical and linguistic abilities to cooperate at the study, signed informed consent

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Exclusion Criteria

contraindication for tilidine or tramadol (allergy against a component of tilidine or tramadol, pregnancy or lactation, severe hepatic or renal impairment (CHILD C; GFR < 15ml/min), seizure disorder, drug abuse, taking of MAO-inhibitors), acute interventional pain (e.g. postoperative pain), indication for pain therapy with opioids of WHO step 3

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Addresses

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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg - Anästhesiologie
    • Mr.  Dr. med.  Klaus  Offner 
    • Hugstetter Straße 55
    • 79106  Freiburg im Breisgau
    • Germany
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Status

  •   Recruiting stopped after recruiting started
  •   2014/12/31
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.