Renal CalculusPhase 4NCT00310908
Comparison Between Tramadol Hcl and Other Analgesics in the Treatment of Renal Colic
A Phase 4 study testing Tramadol Hcl in people with Renal Calculus, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The purpose of this study is to determine whether Tramadol Hcl is as effective as Voltaren a non-steroidal antiinflammatory drug, and Dipyrone in amelioration of the pain caused by acute renal colic. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Renal Calculus
- What is being tested?
- Tramadol Hcl
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2006to Feb 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with clinical diagnosis of acute renal colic (Stage I)
- Patients with diagnosed renal colic who might need prevention of pain and are able to swallow medicines (Stage II)
Who cannot join
- Patients with known hypersensitivity to the study drugs
- Pregnancy or lactation
- Known renal failure or hepatic disease
- Concommitant drug use which could adversely affect patient's outcome (oral anticoagulant, MAO inhibitors)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Tramadol Hcl in the Treatment of Renal Colic
The purpose of this study is to determine whether Tramadol Hcl is as effective as Voltaren a non-steroidal antiinflammatory drug, and Dipyrone in amelioration of the pain caused by acute renal colic.
Read the detailed description
Renal stones is a common condition affecting up to 1% of the american population. The main symptom is renal colic. Acute treatment is based on the administration of analgesics mainly those belonging to non-steroidal antiinflammatory drugs (NSAIDs). Tramadol is an analgesic of the opioid class of analgesics (i.e morphine) and it is considered to cause less side effects with more or less the same analgesic potency. In the present study the analgesic effect of intramuscular Tramadol will be compared with Voltaren (NSAID)in patients attending the Emergency Department (ED) for acute renal colic (Stage I). Most of these patients will not pass their stone during their visit to the ED and they are prone to develop another attack of renal colic.In the second phase of the study (Stage II)patients who improved, and are ready to go home, will be enrolled to get Dipyrone or Tramadol orally for the prevention of further pain.
- Conditions
- Renal Calculus
- Being tested
- Tramadol Hcl
- Keywords
- Renal, Colic, Calculi, Treatment
- Medical subject headings
- Kidney Calculi, Colic, Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tramadol HclDrug
Active Comparator
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain improvement according to VAS score at 30, 60 and 120 minutes(Stage I)
Measured: 30, 60, 120 minutes
Need for rescue medication at 30 minutes (Stage I)
Measured: 30 minutes
Pain improvement according to VAS score at 24 and 48 hrs (Stage II)
Measured: 24 and 48 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2006 (estimated)
- Study startSep 2006
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal CalculusStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Grumental
- Investigators
- Ruth Stalnikowicz, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00310908
- Sponsor's protocol ID
- 1234567-HMO-CTIL
- Status last verified
- Sep 2006
- First submitted
- 4 Apr 2006
- Last updated
- 17 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Ukhal' MI, Melenevskii DA. [Using prostaglandin inhibitor dicloberl in patients with ureteral calculi]. Lik Sprava. 2004 Mar;(2):76-8. Russian.
PubMed 15208882
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Tramadol Hcl in the Treatment of Renal Colic
- ClinicalTrials.gov ID
- NCT00310908
- Acronym / sponsor ID
- 1234567-HMO-CTIL
- Conditions
- Renal Calculus
- Keywords
- Renal, Colic, Calculi, Treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- Grumental
- Study start
- Sep 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 5 Apr 2006 (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 determine whether Tramadol Hcl is as effective as Voltaren a non-steroidal antiinflammatory drug, and Dipyrone in amelioration of the pain caused by acute renal colic.
Detailed description
Renal stones is a common condition affecting up to 1% of the american population. The main symptom is renal colic. Acute treatment is based on the administration of analgesics mainly those belonging to non-steroidal antiinflammatory drugs (NSAIDs). Tramadol is an analgesic of the opioid class of analgesics (i.e morphine) and it is considered to cause less side effects with more or less the same analgesic potency. In the present study the analgesic effect of intramuscular Tramadol will be compared with Voltaren (NSAID)in patients attending the Emergency Department (ED) for acute renal colic (Stage I). Most of these patients will not pass their stone during their visit to the ED and they are prone to develop another attack of renal colic.In the second phase of the study (Stage II)patients who improved, and are ready to go home, will be enrolled to get Dipyrone or Tramadol orally for the prevention of further pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with clinical diagnosis of acute renal colic (Stage I)
- Patients with diagnosed renal colic who might need prevention of pain and are able to swallow medicines (Stage II)
Key exclusion criteria (4 listed)
- Patients with known hypersensitivity to the study drugs
- Pregnancy or lactation
- Known renal failure or hepatic disease
- Concommitant drug use which could adversely affect patient's outcome (oral anticoagulant, MAO inhibitors)
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 |
|---|---|---|
| Tramadol HclActive Comparator | Drug | – |
Primary outcome
Pain improvement according to VAS score at 30, 60 and 120 minutes(Stage I)
Time frame: 30, 60, 120 minutes
Need for rescue medication at 30 minutes (Stage I)
Time frame: 30 minutes
Pain improvement according to VAS score at 24 and 48 hrs (Stage II)
Time frame: 24 and 48 hrs
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 17 Feb 2009.
- Results publication: PubMed 15208882Ukhal' MI, Melenevskii DA. [Using prostaglandin inhibitor dicloberl in patients with ureteral calculi]. Lik Sprava. 2004 Mar;(2):76-8. Russian.
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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.
Ruth Stalnikowicz, MD principal investigator
Hadassah Medical Organization
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 Tramadol Hcl in people with Renal Calculus, run by Hadassah Medical Organization at 1 site in Israel.
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 4 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 17 Feb 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 Israel. 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 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?
Pain improvement according to VAS score at 30, 60 and 120 minutes(Stage I) (time frame: 30, 60, 120 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00310908, which also lists 1 linked publication.
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 17 Feb 2009.