Fast-Release Orodispersible Tramadol Tablet (Tradonal Odis®) as Analgesia for Hysterosalpingography
1 other identifier
interventional
128
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2008
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 4, 2009
CompletedFirst Posted
Study publicly available on registry
May 6, 2009
CompletedMay 6, 2009
May 1, 2009
5 months
May 4, 2009
May 4, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
VAS at the six different assessment points
24 hours
Secondary Outcomes (1)
Adverse effects and complications
24 hours
Study Arms (4)
Tramadol + Metal cannula
ACTIVE COMPARATORFast-release Orodispersible Tramadol Tablet + Metal cannula
Placebo + Metal cannula
PLACEBO COMPARATORPlacebo + Metal cannula
Tramadol + Balloon
ACTIVE COMPARATORFast-release Orodispersible Tramadol Tablet + balloon catheter
Placebo + Balloon
PLACEBO COMPARATORPlacebo + balloon catheter
Interventions
1 tablet of 50 mg Fast-release Orodispersible Tramadol Tablet (Tradonal odis®)
One HSG using a metal canula or balloon catheter, 30 minutes after tablet
Eligibility Criteria
You may qualify if:
- \> 18 and \< 45 years
- Written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UZ Brussel
Brussels, 1090, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Paul Devroey, MD, PhD
Universitair Ziekenhuis Brussel
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 4, 2009
First Posted
May 6, 2009
Study Start
November 1, 2008
Primary Completion
April 1, 2009
Study Completion
April 1, 2009
Last Updated
May 6, 2009
Record last verified: 2009-05