Official Title: “Fast-Release Orodispersible Tramadol Tablet (Tradonal Odis®) as Analgesia for Hysterosalpingography : a Randomized, Controlled, Double Blinded Study”

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.

Study Type: Interventional

Study Design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Study Primary Completion Date: April 2009

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

Intervention(s) in this Clinical Trial

• Drug: Fast-release Orodispersible Tramadol Tablet (Tradonal odis®)
  • 1 tablet of 50 mg Fast-release Orodispersible Tramadol Tablet (Tradonal odis®)
• Procedure: Hysterosalpingography (HSG)
  • One HSG using a metal canula or balloon catheter, 30 minutes after tablet
• Drug: Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Tramadol + Metal cannula
  • Fast-release Orodispersible Tramadol Tablet + Metal cannula
• Placebo Comparator: Placebo + Metal cannula
  • Placebo + Metal cannula
• Active Comparator: Tramadol + Balloon
  • Fast-release Orodispersible Tramadol Tablet + balloon catheter
• Placebo Comparator: Placebo + Balloon
  • Placebo + balloon catheter

Primary Measures

• VAS at the six different assessment points
  • Time Frame: 24 hours
    Safety Issue?: No

Secondary Measures

• Adverse effects and complications
  • Time Frame: 24 hours
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Universitair Ziekenhuis Brussel

Overall Clinical Trial Officials and Contacts

Paul Devroey, MD, PhD Study Director UZ Brussel  

Information obtained from ClinicalTrials.gov on September 02, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00893412

Study ID Number: 2008/191

ClinicalTrials.gov Identifier: NCT00893412

Health Authority: Belgium: Institutional Review Board