Treatment of Axial Spondyloarthritis With Reduced Doses of NSAIDs

NCT02089529 | Completed

• 2 other identifiers: 2010/2528(REK)2013-000098-65
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Axial Spondyloarthritis

Keywords

Axial Spondyloarthritis; Pain; NSAIDs; Placebo; Placebo intervention; Stress; Conditioning

Outcome Measures

Primary Outcomes (1)

• Change in level of pain

  up to 12 weeks

Secondary Outcomes (1)

• Change in level of stress and nervousness

  up to 12 weeks

Study Arms (7)

Ibuprofen/Ibumetin

ACTIVE COMPARATOR

Ibumetin is administrated. Intervention: No information about the effect.

Drug: Ibuprofen

Placebo

PLACEBO COMPARATOR

Placebo is administrated. Intervention: No information about the effect.

Drug: Placebo

Ibuprofen/Ibumetin+positive information

ACTIVE COMPARATOR

Ibumetin is administrated. Intervention: The patient receive written information that the capsule is Ibumetin.

Drug: Ibuprofen

Placebo+positive information

PLACEBO COMPARATOR

Placebo is administrated. Intervention:The patient receive written information that the capsule is Ibumetin.

Drug: Placebo

Ibuprofen/Ibumetin+neutral information

ACTIVE COMPARATOR

Ibumetin is administrated. Intervention: The patient receive written information that the capsule is Ibumetin.

Drug: Ibuprofen

Placebo+neutral information

PLACEBO COMPARATOR

Placebo is administrated. Intervention:The patients receive information that the capsule is placebo.

Drug: Placebo

Control

NO INTERVENTION

Control condition

Interventions

Ibuprofen DRUG

Ibuprofen/Ibumetin with no information, positive information and neutral information

Also known as: Ibumetin

Ibuprofen/Ibumetin; Ibuprofen/Ibumetin+neutral information; Ibuprofen/Ibumetin+positive information

Placebo DRUG

Placebo with no information, positive information and neutral information

Placebo; Placebo+neutral information; Placebo+positive information

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of North Norway: lead
• University of Tromso: collaborator

Study Sites (1)

University Hospital of Northen Norway

Tromsø, Tromsø, 9037, Norway

Location

MeSH Terms

Conditions

Axial Spondyloarthritis; Pain

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Gunnstein Bakland, MD, phd

  UNN

  PRINCIPAL INVESTIGATOR

• Magne Arve Flaten, psycol, phd

  UIT

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2014
• First Posted: March 17, 2014
• Study Start: January 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: December 17, 2015

Record last verified: 2015-12

Locations

NO (1)