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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00893412
First Posted: May 6, 2009
Last Update Posted: May 6, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Universitair Ziekenhuis Brussel
  Purpose

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.


Condition Intervention Phase
Infertility Pain Drug: Fast-release Orodispersible Tramadol Tablet (Tradonal odis®) Procedure: Hysterosalpingography (HSG) Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Fast-Release Orodispersible Tramadol Tablet (Tradonal Odis®) as Analgesia for Hysterosalpingography : a Randomized, Controlled, Double Blinded Study

Resource links provided by NLM:


Further study details as provided by Universitair Ziekenhuis Brussel:

Primary Outcome Measures:
  • VAS at the six different assessment points [ Time Frame: 24 hours ]

Secondary Outcome Measures:
  • Adverse effects and complications [ Time Frame: 24 hours ]

Enrollment: 128
Study Start Date: November 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tramadol + Metal cannula
Fast-release Orodispersible Tramadol Tablet + Metal cannula
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
Placebo Comparator: Placebo + Metal cannula
Placebo + Metal cannula
Procedure: Hysterosalpingography (HSG)
One HSG using a metal canula or balloon catheter, 30 minutes after tablet
Other Name: HSG
Drug: Placebo
Active Comparator: Tramadol + Balloon
Fast-release Orodispersible Tramadol Tablet + balloon catheter
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
Placebo Comparator: Placebo + Balloon
Placebo + balloon catheter
Procedure: Hysterosalpingography (HSG)
One HSG using a metal canula or balloon catheter, 30 minutes after tablet
Other Name: HSG
Drug: Placebo

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
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00893412


Locations
Belgium
UZ Brussel
Brussels, Belgium, 1090
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Investigators
Study Director: Paul Devroey, MD, PhD Universitair Ziekenhuis Brussel
  More Information

Responsible Party: Paul Devroey, UZ Brussel
ClinicalTrials.gov Identifier: NCT00893412     History of Changes
Other Study ID Numbers: 2008/191
First Submitted: May 4, 2009
First Posted: May 6, 2009
Last Update Posted: May 6, 2009
Last Verified: May 2009

Keywords provided by Universitair Ziekenhuis Brussel:
HSG
analgesia
tramadol
metal cannula
balloon catheter

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Tramadol
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents