TRAUMEEL for Pain After Fracture of Neck of Femur

NCT00307905 | Withdrawn Phase 3

• 1 other identifier: NoF 06 CTIL
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• Cumulative 48-hour postoperative morphine consumption

  48h

Secondary Outcomes (9)

• Secondary: AUC of NRS scores for first 48 hrs.;

  48h

• AUC of NRS scores for days 14-17.;

  17d

• Composite measure of pain intensity and opiate consumption;

  17d

• Number of primary oral analgesic tablets ingested between days 14-17;

  17d

• ESR and hs-CPR at three and six days and six weeks;

  42d

Study Arms (2)

A

ACTIVE COMPARATOR

TRAUMEEL S

Drug: Traumeel S

B

PLACEBO COMPARATOR

placebo remedy

Drug: Placebo remedy

Interventions

Traumeel S DRUG

homeopathic remedy

A

Placebo remedy DRUG

identical size, shape and taste of treatment medication

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of either sex undergoing surgical correction of unilateral fracture of neck of hip.
• Age over 18 years.
• Signature upon informed consent form

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

Dept. of Orthopedic Surgery, Shaare Zedek Medical Center

Jerusalem, Israel

Location

MeSH Terms

Conditions

Pain; Femoral Neck Fractures

Interventions

Traumeel S

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Menachem Oberbaum, MD

  Shaare Zedek Medical Center, Jerusalem, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 27, 2006
• First Posted: March 28, 2006
• Study Start: January 1, 2011
• Primary Completion: June 1, 2012
• Last Updated: October 29, 2010

Record last verified: 2010-10

Locations

IL (1)