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Treatment of Axial Spondyloarthritis With Reduced Doses of NSAIDs

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.
 
ClinicalTrials.gov Identifier: NCT02089529
Recruitment Status : Completed
First Posted : March 17, 2014
Last Update Posted : December 17, 2015
Sponsor:
Collaborator:
University of Tromso
Information provided by (Responsible Party):
University Hospital of North Norway

Brief Summary:

The following study investigates the role of information/expectancies in the response to Ibumetin and placebo.

The study is a double-blind randomized controlled trial with crossover, within subjects repeated measurements. The symptoms are measured by questionnaires. 40 patients will be included in the study. The administrated drug is Ibumetin 400 mg.

The study does not require patients to meet in the clinic. Patients will be instructed in how to report pain, tension and nervousness via mobile phone (Checkware AS, Trondheim, Norway).Three days a week for 12 weeks the patients are instructed to report at 0900 AM, and thereafter at 0910, 1100, 1300, 1500, 1700, and 1900 hrs each study day. At these times the patients will receive a sms where they are instructed to immediately rate their pain and stress level and report back.


Condition or disease Intervention/treatment Phase
Axial Spondyloarthritis Drug: Ibuprofen Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Axial Spondyloarthritis With Reduced Doses of NSAIDs: Application of Pharmacotherapeutic Conditioning in Clinical Practice.
Study Start Date : January 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ibuprofen/Ibumetin
Ibumetin is administrated. Intervention: No information about the effect.
Drug: Ibuprofen
Ibuprofen/Ibumetin with no information, positive information and neutral information
Other Name: Ibumetin

Placebo Comparator: Placebo
Placebo is administrated. Intervention: No information about the effect.
Drug: Placebo
Placebo with no information, positive information and neutral information

Active Comparator: Ibuprofen/Ibumetin+positive information
Ibumetin is administrated. Intervention: The patient receive written information that the capsule is Ibumetin.
Drug: Ibuprofen
Ibuprofen/Ibumetin with no information, positive information and neutral information
Other Name: Ibumetin

Placebo Comparator: Placebo+positive information
Placebo is administrated. Intervention:The patient receive written information that the capsule is Ibumetin.
Drug: Placebo
Placebo with no information, positive information and neutral information

Active Comparator: Ibuprofen/Ibumetin+neutral information
Ibumetin is administrated. Intervention: The patient receive written information that the capsule is Ibumetin.
Drug: Ibuprofen
Ibuprofen/Ibumetin with no information, positive information and neutral information
Other Name: Ibumetin

Placebo Comparator: Placebo+neutral information
Placebo is administrated. Intervention:The patients receive information that the capsule is placebo.
Drug: Placebo
Placebo with no information, positive information and neutral information

No Intervention: Control
Control condition



Primary Outcome Measures :
  1. Change in level of pain [ Time Frame: up to 12 weeks ]

Secondary Outcome Measures :
  1. Change in level of stress and nervousness [ Time Frame: up to 12 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have been diagnosed with radiographic Axial Spondyloarthritis, also called Ankylosing Spondylitis, OR
  • Patients must have been diagnosed with non-radiographic Axial Spondyloarthritis with a positive magnetic resonance (MR).
  • Patients must have been successfully treated with NSAIDs for at least three months
  • Patients must be above 20 years old
  • Patients must satisfy the Norwegian Summary of Product Characteristics (SPC) for Ibumetin 400 mg
  • All patients must sign a consent form describing that they will receive placebo during the study period. The Informed Consent Form and The Data Release Form must be signed before inclusion in the studies.

Exclusion Criteria:

  • Patients cannot participate in other clinical studies parallel to the current study. Previous study participations must be completed more than one year, prior to participating in the current study.
  • Patients not satisfying the Norwegian Summary of Product Characteristics (SPC) for Ibumetin 400 mg:
  • Patients who previously have experienced allergic reactions to NSAIDs
  • Patients with previous or currant ulcers and/or gastrointestinal conditions - or bleeding
  • Patients with previous or currant cardiovascular conditions, or have experienced cardiovascular episodes
  • Patients with previous or currant renal failure
  • Patients with acetaminophen - or NSAID-induced asthma, urticarial or rhinitic
  • Patients with previous or current other serious conditions apart from rheumatoid arthritis
  • Female patients trying to or having trouble getting pregnant cannot participate in the study
  • Pregnant and/or nursing patients cannot participate in the study
  • Patients on a treatment plan with Prednisolon
  • Patients on a treatment plan with substances inflicting with Ibumetin. All substances will be investigated on www.interaksjoner.no

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): NCT02089529


Locations
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Norway
University Hospital of Northen Norway
Tromsø, Norway, 9037
Sponsors and Collaborators
University Hospital of North Norway
University of Tromso
Investigators
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Principal Investigator: Gunnstein Bakland, MD, phd UNN
Study Director: Magne Arve Flaten, psycol, phd UIT
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Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT02089529    
Other Study ID Numbers: 2010/2528(REK)
2013-000098-65 ( EudraCT Number )
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: December 17, 2015
Last Verified: December 2015
Keywords provided by University Hospital of North Norway:
Axial Spondyloarthritis
Pain
NSAIDs
Placebo
Placebo intervention
Stress
Conditioning
Additional relevant MeSH terms:
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Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action