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

This study has been completed.
Sponsor:
Information provided by:
Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT00893412
First received: May 4, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse effects and complications [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00893412

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

No publications provided

Responsible Party: Paul Devroey, UZ Brussel
ClinicalTrials.gov Identifier: NCT00893412     History of Changes
Other Study ID Numbers: 2008/191
Study First Received: May 4, 2009
Last Updated: May 4, 2009
Health Authority: Belgium: Institutional Review Board

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
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014