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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

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Prof Paul Rolan, University of Adelaide

Tracking Information
First Submitted Date  ICMJE March 11, 2011
First Posted Date  ICMJE March 14, 2011
Last Update Posted Date February 6, 2013
Study Start Date  ICMJE November 2010
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2011)
Daily pain scores on a numerical rating scale [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01314482 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2011)
Hypo/hyperaesthesia to punctate sensation [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Minocycline for the Prevention of Post-operative Intercostal Neuralgia
Official Title  ICMJE The Efficacy of Prophylactic Administration of Minocycline in Reducing Chronic Intercostal Neuralgia Post-thoracotomy
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Post-operative Intercostal Neuralgia
Intervention  ICMJE Drug: Minocycline
200mg bd for 3 days before surgery
Study Arms  ICMJE Experimental: Minocycline
Intervention: Drug: Minocycline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 11, 2011)
116
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2014
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01314482
Other Study ID Numbers  ICMJE U1111-1119-6985
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof Paul Rolan, University of Adelaide
Study Sponsor  ICMJE University of Adelaide
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Adelaide
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP