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Trial record 1 of 6 for:    "Neuromuscular Disease" | "Minocycline"
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Minocycline for the Prevention of Post-operative Intercostal Neuralgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01314482
Recruitment Status : Unknown
Verified February 2013 by Prof Paul Rolan, University of Adelaide.
Recruitment status was:  Recruiting
First Posted : March 14, 2011
Last Update Posted : February 6, 2013
Information provided by (Responsible Party):
Prof Paul Rolan, University of Adelaide

Brief Summary:
In about half the patients who have an open chest surgery there is persistent severe pain in the chest. The investigators are examining whether minocycline, a commonly used antibiotic, will prevent pain. Minocycline blocks the activity of immune cells which the investigators believe are responsible for prolonging the pain.

Condition or disease Intervention/treatment Phase
Post-operative Intercostal Neuralgia Drug: Minocycline Phase 2

Detailed Description:
The study is of double-blind placebo controlled parallel groups design in up to 116 patients undergoing elective open thoracotomy. Minocycline 200mg twice daily or matching placebo are given three days before surgery.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy of Prophylactic Administration of Minocycline in Reducing Chronic Intercostal Neuralgia Post-thoracotomy
Study Start Date : November 2010
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Minocycline Drug: Minocycline
200mg bd for 3 days before surgery

Primary Outcome Measures :
  1. Daily pain scores on a numerical rating scale [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Hypo/hyperaesthesia to punctate sensation [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female
  • Aged 18 years or older
  • Undertaking elective, open thoracotomy with ample time pre-operatively to provide informed consent and undertake dosing
  • Sufficient fluency in English language to read and understand consent form, fulfil study requirements and communicate with research staff
  • Negative pregnancy test at screening for women of child bearing potential
  • Females of child bearing potential must agree to use a medically acceptable method of contraception other than oral contraceptives from time of first dosing until one week post-operatively. Acceptable methods include abstinence, contraceptive patches, NuvaRing (etonogestrel/ethinyl oestradiol vaginal ring), diaphragm with vaginal spermicide, intrauterine device, condom and vaginal spermicide, progestin implant or injection
  • Avoid prolonged, direct sunlight or ultra-violet light exposure during dosing period
  • Refrain from strenuous activities and avoid changes to regular exercise patterns throughout trial period

Exclusion Criteria:

  • Pregnant or breast feeding
  • Known allergy to minocycline and other tetracycline antibiotics
  • Pre-existing neuralgic pain condition in area designated for operation
  • Physical abnormality in area designated for operation
  • Taking disallowed concomitant medication
  • Renal insufficiency as determined by a calculated creatinine clearance of < 60mL/min
  • Hepatic dysfunction as determined by alanine transaminase and/or aspartate transaminase in excess of three times upper normal limits
  • Diagnosis of systemic lupus erythematosus
  • Recent diagnosis of enterocolitis or colitis
  • Participation in another trial of an investigational product within 30 days of commencing dosing or are scheduled to commence trial of an investigational product during study period
  • Patients who, in an Investigator's opinion, should not participate in the trial or may not be capable of following the trial schedule for any reason
  • History of major psychiatric disorder not medically controlled

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01314482

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Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Melanie Gentgall, RN    +61 8 82222712   
Contact: James Swift, BHlthSci(Hons)    +61 8 82222712   
Principal Investigator: Craig Jurisevic, MD         
Sub-Investigator: Paul E Rolan, MD         
Sponsors and Collaborators
University of Adelaide

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Responsible Party: Prof Paul Rolan, Professor of Clinical Pharmacology, University of Adelaide Identifier: NCT01314482     History of Changes
Other Study ID Numbers: U1111-1119-6985
First Posted: March 14, 2011    Key Record Dates
Last Update Posted: February 6, 2013
Last Verified: February 2013
Keywords provided by Prof Paul Rolan, University of Adelaide:
Neuropathic pain
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Anti-Bacterial Agents
Anti-Infective Agents