InfertilityPhase 4NCT00893412
Fast-Release Orodispersible Tramadol Tablet (Tradonal Odis®) as Analgesia for Hysterosalpingography
A Phase 4 study testing Fast-release Orodispersible Tramadol Tablet (Tradonal odis®) and Hysterosalpingography (HSG) in people with Infertility and Pain, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Infertility, Pain
- What is being tested?
- Fast-release Orodispersible Tramadol Tablet (Tradonal odis®) and Hysterosalpingography (HSG)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2008to Apr 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- > 18 and < 45 years
- Written informed consent
Who cannot join
- 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
Show all 9Show fewer
- Presence of pelvic inflammatory disease or any other condition causing pelvic pain
- Clinical and/or laboratory evidence of any major disease
- Pregnant or lactating
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Infertility, Pain
- Being tested
- Fast-release Orodispersible Tramadol Tablet (Tradonal odis®), Hysterosalpingography (HSG), Placebo
- Keywords
- HSG, analgesia, tramadol, metal cannula, balloon catheter
- Medical subject headings
- Infertility, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast-release Orodispersible Tramadol Tablet (Tradonal odis®)Drug
Also called Tradonal odis®
1 tablet of 50 mg Fast-release Orodispersible Tramadol Tablet (Tradonal odis®)
Hysterosalpingography (HSG)Procedure or surgery
Also called HSG
One HSG using a metal canula or balloon catheter, 30 minutes after tablet
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Tramadol + Metal cannula | Active comparator | Fast-release Orodispersible Tramadol Tablet + Metal cannula Receives: Drug: Fast-release Orodispersible Tramadol Tablet (Tradonal odis®); Procedure: Hysterosalpingography (HSG) |
| Placebo + Metal cannula | Placebo comparator | Placebo + Metal cannula Receives: Procedure: Hysterosalpingography (HSG); Drug: Placebo |
| Tramadol + Balloon | Active comparator | Fast-release Orodispersible Tramadol Tablet + balloon catheter Receives: Drug: Fast-release Orodispersible Tramadol Tablet (Tradonal odis®); Procedure: Hysterosalpingography (HSG) |
| Placebo + Balloon | Placebo comparator | Placebo + balloon catheter Receives: Procedure: Hysterosalpingography (HSG); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS at the six different assessment points
Measured: 24 hours
Secondary outcomes (1)
Adverse effects and complications
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2009 (estimated)
- Study startNov 2008
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Investigators
- Paul Devroey, MD, PhD, Study director, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00893412
- Sponsor's protocol ID
- 2008/191
- Status last verified
- May 2009
- First submitted
- 4 May 2009
- Last updated
- 6 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fast-Release Orodispersible Tramadol Tablet (Tradonal Odis®) as Analgesia for Hysterosalpingography : a Randomized, Controlled, Double Blinded Study
- ClinicalTrials.gov ID
- NCT00893412
- Acronym / sponsor ID
- 2008/191
- Conditions
- Infertility, Pain
- Keywords
- HSG, analgesia, tramadol, metal cannula, balloon catheter
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 6 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tramadol + Metal cannula | Active comparator | Drug: Fast-release Orodispersible Tramadol Tablet (Tradonal odis®), Procedure: Hysterosalpingography (HSG)Fast-release Orodispersible Tramadol Tablet + Metal cannula |
| Placebo + Metal cannula | Placebo comparator | Procedure: Hysterosalpingography (HSG), Drug: PlaceboPlacebo + Metal cannula |
| Tramadol + Balloon | Active comparator | Drug: Fast-release Orodispersible Tramadol Tablet (Tradonal odis®), Procedure: Hysterosalpingography (HSG)Fast-release Orodispersible Tramadol Tablet + balloon catheter |
| Placebo + Balloon | Placebo comparator | Procedure: Hysterosalpingography (HSG), Drug: PlaceboPlacebo + balloon catheter |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- > 18 and < 45 years
- Written informed consent
Key exclusion criteria (9 listed)
- Contra-indication to tramadol, morphine or to other opioids
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fast-release Orodispersible Tramadol Tablet (Tradonal odis®)Also: Tradonal odis®1 tablet of 50 mg Fast-release Orodispersible Tramadol Tablet (Tradonal odis®) | Drug | Tramadol + Balloon, Tramadol + Metal cannula |
| Hysterosalpingography (HSG)Also: HSGOne HSG using a metal canula or balloon catheter, 30 minutes after tablet | Procedure or surgery | Placebo + Balloon, Placebo + Metal cannula, Tramadol + Balloon, Tramadol + Metal cannula |
| Placebo | Drug | Placebo + Balloon, Placebo + Metal cannula |
Primary outcome
VAS at the six different assessment points
Time frame: 24 hours
1 secondary outcome
Adverse effects and complications
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Devroey, MD, PhD study director
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fast-release Orodispersible Tramadol Tablet (Tradonal odis®) and Hysterosalpingography (HSG) in people with Infertility and Pain, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS at the six different assessment points (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2009.