PainPhase 3NCT00307905
TRAUMEEL for Pain After Fracture of Neck of Femur
A Phase 3 study testing Traumeel S in people with Pain and Fracture of Neck of Femur, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
We hypothesize that Traumeel S is more effective than placebo in reducing 48-hour mean cumulative morphine consumption in patients scheduled for surgical correction of fracture of neck of hip. 224 patients, meeting all inclusion and none of exclusion criteria, will be enrolled in the trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Fracture of Neck of Femur
- What is being tested?
- Traumeel S
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 224 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2011to Jun 2012
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of either sex undergoing surgical correction of unilateral fracture of neck of hip.
- Age over 18 years.
- Signature upon informed consent form
Who cannot join
- Participation in another clinical trial within 4 weeks prior to enrollment.
- Refused to give verbal consent to the telephone interviews
- Impossibility to be reached during the 14-17 days post operative
- Inability to comply with the study protocol for any other reason
- Previous major surgical procedure on ipsilateral hip.
- Current use of analgesics for any other reason.
Show all 10Show fewer
- A history of chronic pain syndrome.
- Abused legal or illicit drug use.
- Hypersensitivity to botanicals of the Compositae family
- Known sensitivity to paracetamol, codeine or tramadol.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Dept. of Orthopedic Surgery, Shaare Zedek Medical Center
Jerusalem
About this study
Official title: A Randomised, Double - Blind, Placebo Controlled Clinical Trial to Assess the Efficacy of the Homeopathic Medication TRAUMEEL S in Controlling Post-operative Pain After Fracture of Neck of Femur
We hypothesize that Traumeel S is more effective than placebo in reducing 48-hour mean cumulative morphine consumption in patients scheduled for surgical correction of fracture of neck of hip.
224 patients, meeting all inclusion and none of exclusion criteria, will be enrolled in the trial. Patients will be randomized to receive either intraoperative injection and post operative oral Traumeel S Tablets or placebo injection (normal saline) and indistinguishable oral placebo tablets. Baseline measurements of relevant outcome measures will taken preoperatively. Immediately after surgery, patients will receive an initial dose of morphine of 0.1mg/kg body weight. Patients will take the oral study medication for 21 days. Every four hours after surgery, patients will be asked to grade their pain on an NRS. Subsequent doses of morphine will be calculated based upon the patient's weight and current NRS, according to a preplanned scheme. Patients will be permitted to request additional morphine, beyond their calculated dose.
- Conditions
- Pain, Fracture of Neck of Femur
- Being tested
- Traumeel S, Placebo remedy
- Keywords
- homeopathy, pain, traumeel s, Fracture of neck of femur, Surgical correction of fracture of neck of hip
- Medical subject headings
- Pain, Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traumeel SDrug
homeopathic remedy
Placebo remedyDrug
identical size, shape and taste of treatment medication
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | TRAUMEEL S Receives: Drug: Traumeel S |
| B | Placebo comparator | placebo remedy Receives: Drug: Placebo remedy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative 48-hour postoperative morphine consumption
Measured: 48h
Secondary outcomes (9)
Secondary: AUC of NRS scores for first 48 hrs.;
Measured: 48h
AUC of NRS scores for days 14-17.;
Measured: 17d
Composite measure of pain intensity and opiate consumption;
Measured: 17d
Number of primary oral analgesic tablets ingested between days 14-17;
Measured: 17d
ESR and hs-CPR at three and six days and six weeks;
Measured: 42d
IL-6 at three and six days;
Measured: 6d
Post operative blood loss;
Measured: 48h
WOMAC;
Measured: 17d
Safety of post operative treatment
Measured: 17d
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2006 (estimated)
- Study startJan 2011
- Primary completionJun 2012 (estimated)
Why it stopped: Anticipation of inadequate recruitment according to current format.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Menachem Oberbaum, MD, Principal investigator, Shaare Zedek Medical Center, Jerusalem, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00307905
- Sponsor's protocol ID
- NoF 06 CTIL
- Status last verified
- Oct 2010
- First submitted
- 27 Mar 2006
- Last updated
- 29 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double - Blind, Placebo Controlled Clinical Trial to Assess the Efficacy of the Homeopathic Medication TRAUMEEL S in Controlling Post-operative Pain After Fracture of Neck of Femur
- ClinicalTrials.gov ID
- NCT00307905
- Acronym / sponsor ID
- NoF 06 CTIL
- Conditions
- Pain, Fracture of Neck of Femur
- Keywords
- homeopathy, pain, traumeel s, Fracture of neck of femur, Surgical correction of fracture of neck of hip
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Anticipation of inadequate recruitment according to current format.
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jun 2012 (estimated)
- First posted
- 28 Mar 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.
We hypothesize that Traumeel S is more effective than placebo in reducing 48-hour mean cumulative morphine consumption in patients scheduled for surgical correction of fracture of neck of hip.
224 patients, meeting all inclusion and none of exclusion criteria, will be enrolled in the trial. Patients will be randomized to receive either intraoperative injection and post operative oral Traumeel S Tablets or placebo injection (normal saline) and indistinguishable oral placebo tablets. Baseline measurements of relevant outcome measures will taken preoperatively. Immediately after surgery, patients will receive an initial dose of morphine of 0.1mg/kg body weight. Patients will take the oral study medication for 21 days. Every four hours after surgery, patients will be asked to grade their pain on an NRS. Subsequent doses of morphine will be calculated based upon the patient's weight and current NRS, according to a preplanned scheme. Patients will be permitted to request additional morphine, beyond their calculated dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Traumeel STRAUMEEL S |
| B | Placebo comparator | Drug: Placebo remedyplacebo remedy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of either sex undergoing surgical correction of unilateral fracture of neck of hip.
- Age over 18 years.
- Signature upon informed consent form
Key exclusion criteria (10 listed)
- Participation in another clinical trial within 4 weeks prior to enrollment.
- Refused to give verbal consent to the telephone interviews
- Impossibility to be reached during the 14-17 days post operative
- Inability to comply with the study protocol for any other reason
- Previous major surgical procedure on ipsilateral hip.
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 |
|---|---|---|
| Traumeel Shomeopathic remedy | Drug | A |
| Placebo remedyidentical size, shape and taste of treatment medication | Drug | B |
Primary outcome
Cumulative 48-hour postoperative morphine consumption
Time frame: 48h
9 secondary outcomes
Secondary: AUC of NRS scores for first 48 hrs.;
Time frame: 48h
AUC of NRS scores for days 14-17.;
Time frame: 17d
Composite measure of pain intensity and opiate consumption;
Time frame: 17d
Number of primary oral analgesic tablets ingested between days 14-17;
Time frame: 17d
ESR and hs-CPR at three and six days and six weeks;
Time frame: 42d
IL-6 at three and six days;
Time frame: 6d
Post operative blood loss;
Time frame: 48h
WOMAC;
Time frame: 17d
Safety of post operative treatment
Time frame: 17d
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2010.
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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.
Menachem Oberbaum, MD principal investigator
Shaare Zedek Medical Center, Jerusalem, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Traumeel S in people with Pain and Fracture of Neck of Femur, run by Shaare Zedek Medical Center 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 3 inclusion and 10 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: withdrawn, as of the sponsor's last update on 29 Oct 2010. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
Cumulative 48-hour postoperative morphine consumption (time frame: 48h). 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 29 Oct 2010.