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Trial record 26 of 135 for:    AMITRIPTYLINE

Prospective, Cross Over Gabapentin vs Amitriptyline Study on Patients Suffering From Masticatory Muscle Pain

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ClinicalTrials.gov Identifier: NCT02339662
Recruitment Status : Unknown
Verified October 2015 by Doron Aframian, Hadassah Medical Organization.
Recruitment status was:  Recruiting
First Posted : January 15, 2015
Last Update Posted : October 20, 2015
Sponsor:
Information provided by (Responsible Party):
Doron Aframian, Hadassah Medical Organization

Brief Summary:
The purpose of the study is comparing two drugs efficacy for the treatment of pain originates from masticatory muscles. The two drugs are - Amitriptlyne (amitriptyline) and Gabapentin (gabapentin), both of them are common use in for the treatment of chronic pain Methods - patient that is diagnosed as suffering from myofacial pain, will receive one of the medications above (Gabapentin or amitriptyline) for one month only, after which he will be invited to pain clinic for control. Two weeks after that, the patient will start taking the other drug for 1 month and then invited again to the department for recall and continue standard treatment . The patient can choose whether to continue medication with one of the drugs or stop this medication treatment. Total duration of the experiment is two and a half months.

Condition or disease Intervention/treatment Phase
Myofacial Pain Drug: Gabapentin Drug: Amitriptyline Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Cross Over Gabapentin vs Amitriptyline Study on Patients Suffering From Masticatory Muscle Pain
Study Start Date : February 2015
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: gabapentin
900 mg per day total, 3 pills of 300mg.
Drug: Gabapentin
muscles pain treatment

Active Comparator: amitriptyline
20 mg total, 1pill
Drug: Amitriptyline
muscles pain treatment
Other Name: alterolet




Primary Outcome Measures :
  1. pain decrease [ Time Frame: 6 weeks ]
    pain scale measuring


Secondary Outcome Measures :
  1. The frequency of use of other drugs [ Time Frame: 6 weeks ]
    breacking drugs registration

  2. Improving function - open mouth, free jaw movement [ Time Frame: 6 weeks ]
    opening mouth measurement



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who suffer from chronic pain more than 3 months prior to arrival
  • patients who are capable to reach all the visits in the clinic
  • Not pregnant women

Exclusion Criteria:

  • Patients with other types of non-muscle origin pain
  • Patients without a clear diagnosis.
  • Patients who are not originally designated to medication treatment (regardless experiment) for various reasons eg pregnancy.
  • Patients who are not interested in medication.
  • Patients who are not interested or unable to cooperate.
  • Patients who suffer from chronic pain less than 3 months prior to arrival
  • Pregnant women

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 ClinicalTrials.gov identifier (NCT number): NCT02339662


Contacts
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Contact: Doron J Aframian, DMD, PhD 972-2-677-6140 Dorona@hadassah.org.il
Contact: Yaron Haviv, DMD, PhD 972-2-6776140 yaron.haviv@gmail.com

Locations
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Israel
Hadassah MO Recruiting
Jerusalem, Israel
Contact: Doron J Aframian, MD,PhD    97226776140    dorona@hadassah.org.il   
Sponsors and Collaborators
Doron Aframian
Investigators
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Principal Investigator: Doron J Aframian, DMD,PhD Hadassah Medical Organization

Publications:

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Responsible Party: Doron Aframian, Professor in Oral Medicine, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT02339662     History of Changes
Other Study ID Numbers: gbvsam001-HMO-CTIL
First Posted: January 15, 2015    Key Record Dates
Last Update Posted: October 20, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Amitriptyline
Amitriptyline, perphenazine drug combination
Myalgia
Facial Pain
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Musculoskeletal Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Antidepressive Agents, Tricyclic
Antidepressive Agents
Analgesics, Non-Narcotic