Choroidal MelanomaPhase 1/2NCT00111046
Pain Relief - Tramadol Versus Ibuprofen
A Phase 1/2 study testing Ibuprofen and Tramadol in people with Choroidal Melanoma and Melanoma, run by Royal Liverpool University Hospital at 1 site in United Kingdom.
Trial summary
The purpose of this study is to assess post operative pain following the insertion of radioactive plaque for choroidal melanoma in patients after receiving either ibuprofen or tramadol. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Choroidal Melanoma, Melanoma, Eye Neoplasms
- What is being tested?
- Ibuprofen and Tramadol
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2001to Feb 2004
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients that are admitted for undergoing plaque radiotherapy for choroidal melanoma would be approached to participate in this study.
- They should be adults who are of a sound frame of mind to give an informed consent to participate.
Who cannot join
- Patients less than 18 years of age
- Patients of unsound mind not capable of giving informed consent
- Active peptic ulcer disease, asthma, renal dysfunction, warfarin therapy, hypothyroidism history of epilepsy, pregnancy, breastfeeding and hypersensitivity to either products.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Liverpool University Hospital
Liverpool, Merseyside, L8 0RU
About this study
Official title: Post-Operative Pain Relief Following Insertion of Radioactive Plaque for Choroidal Melanoma: Randomised Control Trial of Tramadol Vs Ibuprofen: A Pilot Study
The purpose of this study is to assess post operative pain following the insertion of radioactive plaque for choroidal melanoma in patients after receiving either ibuprofen or tramadol.
Read the detailed description
Patients with choroidal melanomas who are offered ruthenium plaque radiotherapy have their plaque sutured to the sclera under general anaesthesia. The plaque is removed in a few days after delivering the required radioactive dosage to the tumour. While the plaque is in situ, patients require analgesia. The management of post-operative pain is generally not considered a high priority, more importance being given to the regression of the melanoma.
This is indicated by the lack of any study addressing this aspect of care. The failure of patients in general, to complain, may perhaps be due to them having accepted that some degree of pain following 'major surgery for a malignant ocular condition' is the norm.
As per current protocol, ibuprofen is being prescribed, unless contraindicated. Although many are comfortable, others request additional analgesics. Most opioid analgesics provide better pain relief but are associated with nausea, vomiting, constipation and respiratory depression.
Tramadol is an opioid analgesic that is reported to have less of the above mentioned side affects.
Comparisons: To compare the analgesic effect of oral tramadol versus ibuprofen in such patients.
- Conditions
- Choroidal Melanoma, Melanoma, Eye Neoplasms
- Being tested
- Ibuprofen, Tramadol
- Keywords
- Pain Relief, Choroidal melanoma, plaque radiotherapy
- Medical subject headings
- Uveal Melanoma, Melanoma, Eye Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
TramadolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare levels of pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2005 (estimated)
- Study startFeb 2001
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Choroidal MelanomaStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Royal Liverpool University Hospital
- Sponsor type
- Other government
- Investigators
- Bertil Damato, Principal investigator, Royal Liverpool University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00111046
- Sponsor's protocol ID
- 2K/261
- Other IDs
- R&D 1931
- Status last verified
- May 2005
- First submitted
- 16 May 2005
- Last updated
- 10 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Operative Pain Relief Following Insertion of Radioactive Plaque for Choroidal Melanoma: Randomised Control Trial of Tramadol Vs Ibuprofen: A Pilot Study
- ClinicalTrials.gov ID
- NCT00111046
- Acronym / sponsor ID
- 2K/261
- Conditions
- Choroidal Melanoma, Melanoma, Eye Neoplasms
- Keywords
- Pain Relief, Choroidal melanoma, plaque radiotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants
- Lead sponsor
- Royal Liverpool University HospitalOther government
- Study start
- Feb 2001
- Study completion
- Feb 2004
- First posted
- 17 May 2005 (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.
The purpose of this study is to assess post operative pain following the insertion of radioactive plaque for choroidal melanoma in patients after receiving either ibuprofen or tramadol.
Detailed description
Patients with choroidal melanomas who are offered ruthenium plaque radiotherapy have their plaque sutured to the sclera under general anaesthesia. The plaque is removed in a few days after delivering the required radioactive dosage to the tumour. While the plaque is in situ, patients require analgesia. The management of post-operative pain is generally not considered a high priority, more importance being given to the regression of the melanoma.
This is indicated by the lack of any study addressing this aspect of care. The failure of patients in general, to complain, may perhaps be due to them having accepted that some degree of pain following 'major surgery for a malignant ocular condition' is the norm.
As per current protocol, ibuprofen is being prescribed, unless contraindicated. Although many are comfortable, others request additional analgesics. Most opioid analgesics provide better pain relief but are associated with nausea, vomiting, constipation and respiratory depression.
Tramadol is an opioid analgesic that is reported to have less of the above mentioned side affects.
Comparisons: To compare the analgesic effect of oral tramadol versus ibuprofen in such patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients that are admitted for undergoing plaque radiotherapy for choroidal melanoma would be approached to participate in this study.
- They should be adults who are of a sound frame of mind to give an informed consent to participate.
Key exclusion criteria (3 listed)
- Patients less than 18 years of age
- Patients of unsound mind not capable of giving informed consent
- Active peptic ulcer disease, asthma, renal dysfunction, warfarin therapy, hypothyroidism history of epilepsy, pregnancy, breastfeeding and hypersensitivity to either products.
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 |
|---|---|---|
| Ibuprofen | Drug | – |
| Tramadol | Drug | – |
Primary outcome
Compare levels of pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2005.
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A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma
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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.
Bertil Damato principal investigator
Royal Liverpool University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ibuprofen and Tramadol in people with Choroidal Melanoma and Melanoma, run by Royal Liverpool University Hospital at 1 site in United Kingdom.
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 3 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: status not confirmed, as of the sponsor's last update on 10 Nov 2005. 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 United Kingdom. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Compare levels of pain. 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 10 Nov 2005.