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Fast-Release Orodispersible Tramadol Tablet (Tradonal Odis®) as Analgesia for Hysterosalpingography

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ClinicalTrials.gov Identifier: NCT00893412
Recruitment Status : Completed
First Posted : May 6, 2009
Last Update Posted : May 6, 2009
Sponsor:
Information provided by:
Universitair Ziekenhuis Brussel

Tracking Information
First Submitted Date  ICMJE May 4, 2009
First Posted Date  ICMJE May 6, 2009
Last Update Posted Date May 6, 2009
Study Start Date  ICMJE November 2008
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2009)
VAS at the six different assessment points [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2009)
Adverse effects and complications [ Time Frame: 24 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fast-Release Orodispersible Tramadol Tablet (Tradonal Odis®) as Analgesia for Hysterosalpingography
Official Title  ICMJE Fast-Release Orodispersible Tramadol Tablet (Tradonal Odis®) as Analgesia for Hysterosalpingography : a Randomized, Controlled, Double Blinded Study
Brief Summary

This study evaluates the analgetic effects of the fast-release orodispersible tramadol tablet.

Tramadol acts through a weak affinity for μ receptors and secondly by inhibiting noradrenaline and serotonin neuronal reuptake. It has been used since the 1970s by over 50 million people for the treatment of acute and chronic pain. The orodispersible Tramadol tablet is a new galenic form and is available on the Belgian market for the last three years. Pregastric absorption leads to a quicker onset of action.

So far, evidence shows that pain during and immediately after the Hysterosalpingography (HSG) procedure is only significantly reduced by IV opioid analgesia. This study evaluates the analgetic potential of an orodispersible opioid tablet. This tablet disintegrates rapidly (in around 20-30 seconds) and may be taken without water. Its abuse potential is very low and its respiratory depressant effect is negligible.

Detailed Description

Four arm prospective randomized double blinded trial

Patients that need a HSG as part of their diagnostic work-up and are eligible for randomization are counseled about possible participation. After signing the informed consent patients will be randomized in one of the following four groups:

Group 1: Fast-release Orodispersible Tramadol Tablet + metal cannula Group 2: Placebo + metal cannula Group 3: Fast-release Orodispersible Tramadol Tablet + balloon catheter Group 4: Placebo + balloon catheter

Tablets are administered 30 min before the procedure

Primary Endpoint:

  • VAS at the six different assessment points

Secondary Endpoint

  • adverse effects and complications such as: nausea, vomiting, constipation, drowsiness, respiratory depression, hypotension, allergic reaction and infection
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Infertility
  • Pain
Intervention  ICMJE
  • Drug: Fast-release Orodispersible Tramadol Tablet (Tradonal odis®)
    1 tablet of 50 mg Fast-release Orodispersible Tramadol Tablet (Tradonal odis®)
    Other Name: Tradonal odis®
  • Procedure: Hysterosalpingography (HSG)
    One HSG using a metal canula or balloon catheter, 30 minutes after tablet
    Other Name: HSG
  • Drug: Placebo
Study Arms  ICMJE
  • Active Comparator: Tramadol + Metal cannula
    Fast-release Orodispersible Tramadol Tablet + Metal cannula
    Interventions:
    • Drug: Fast-release Orodispersible Tramadol Tablet (Tradonal odis®)
    • Procedure: Hysterosalpingography (HSG)
  • Placebo Comparator: Placebo + Metal cannula
    Placebo + Metal cannula
    Interventions:
    • Procedure: Hysterosalpingography (HSG)
    • Drug: Placebo
  • Active Comparator: Tramadol + Balloon
    Fast-release Orodispersible Tramadol Tablet + balloon catheter
    Interventions:
    • Drug: Fast-release Orodispersible Tramadol Tablet (Tradonal odis®)
    • Procedure: Hysterosalpingography (HSG)
  • Placebo Comparator: Placebo + Balloon
    Placebo + balloon catheter
    Interventions:
    • Procedure: Hysterosalpingography (HSG)
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 4, 2009)
128
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • > 18 and < 45 years
  • Written informed consent

Exclusion Criteria:

  • Contra-indication to tramadol, morphine or to other opioids

    • Concomitant use of MAO inhibitors or use less than 2 weeks prior to procedure
    • Use of any other CNS-acting drug
  • Contra-indication to radio-contrast medium (allergy)
  • Patient already taking analgetics
  • History of cervical stenosis
  • Presence of pelvic inflammatory disease or any other condition causing pelvic pain
  • Clinical and/or laboratory evidence of any major disease
  • Pregnant or lactating
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00893412
Other Study ID Numbers  ICMJE 2008/191
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Paul Devroey, UZ Brussel
Study Sponsor  ICMJE Universitair Ziekenhuis Brussel
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Paul Devroey, MD, PhD Universitair Ziekenhuis Brussel
PRS Account Universitair Ziekenhuis Brussel
Verification Date May 2009

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