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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00307905
Other study ID # NoF 06 CTIL
Secondary ID
Status Withdrawn
Phase Phase 3
First received March 27, 2006
Last updated October 28, 2010
Start date January 2011

Study information

Verified date October 2010
Source Shaare Zedek Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 224
Est. completion date
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients of either sex undergoing surgical correction of unilateral fracture of neck of hip.

- Age over 18 years.

- Signature upon informed consent form

Exclusion Criteria:

- 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.

- 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
Traumeel S
homeopathic remedy
Placebo remedy
identical size, shape and taste of treatment medication

Locations

Country Name City State
Israel Dept. of Orthopedic Surgery, Shaare Zedek Medical Center Jerusalem

Sponsors (1)

Lead Sponsor Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cumulative 48-hour postoperative morphine consumption 48h Yes
Secondary Secondary: AUC of NRS scores for first 48 hrs.; 48h Yes
Secondary AUC of NRS scores for days 14-17.; 17d Yes
Secondary Composite measure of pain intensity and opiate consumption; 17d Yes
Secondary Number of primary oral analgesic tablets ingested between days 14-17; 17d Yes
Secondary ESR and hs-CPR at three and six days and six weeks; 42d No
Secondary IL-6 at three and six days; 6d No
Secondary Post operative blood loss; 48h Yes
Secondary WOMAC; 17d Yes
Secondary Safety of post operative treatment 17d Yes
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