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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009333
Receipt No. R000010959
Scientific Title The effect of NSAIDs on sleep quality in chronic low back pain patients with sleep disorder (A randomized, open-label, parallel-group comparison study)
Date of disclosure of the study information 2012/11/15
Last modified on 2014/06/18

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Basic information
Public title The effect of NSAIDs on sleep quality in chronic low back pain patients with sleep disorder (A randomized, open-label, parallel-group comparison study)
Acronym The effect of NSAIDs on sleep quality in chronic low back pain patients with sleep disorder
Scientific Title The effect of NSAIDs on sleep quality in chronic low back pain patients with sleep disorder (A randomized, open-label, parallel-group comparison study)
Scientific Title:Acronym The effect of NSAIDs on sleep quality in chronic low back pain patients with sleep disorder
Region
Japan

Condition
Condition Low Back Pain
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to perform an exploratory examination of the improvement effect on sleep disorder at 12 weeks after treatment in chronic low back pain patients with sleep disorder, in comparison between a group of celecoxib and a group of loxoprofen sodium.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Evaluation on the improvement effect on the quality of sleep using the Pittsburgh Sleep Quality Index(PSQI) after 12-week study treatment
Key secondary outcomes 1) Evaluation on the long-acting effect of the pain relief using the Visual Analog scale (VAS)
2) Evaluation on the effect of the pain relief using VAS
3) Improvement effect on low back pain-specific QOL using the Roland-Morris Disability Questionnaire (RDQ)
4) Evaluation on overall improvement
5) Evaluation on intention for treatment continuation (questionnaire to patients)
6) Evaluation on the incidence of gastrointestinal adverse drug reactions (questionnaire to patients)
7) Evaluation of sleep quality using sleep electroencephalogram as a parameter
8) Evaluation on the improvement effect on the quality of sleep using the PSQI. (day 28 and day 56 after treatment)
9) Evaluation on the improvement effect on the quality of sleep using the Medical Outcomes Study Sleep Scale (MOS-SS)
10) The % of Patients Requesting Rescue Medication.
11) The % of patient with PSQI score more than 6 point

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients in celecoxib group are administrated celecoxib 100 mg twice per day for 12 weeks
Interventions/Control_2 Patients in loxoprofen group are administrated loxoprofen 60 mg three times per day for 12 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria 1) Inpatient/outpatient status: Both
2) Disease, severity: Patients diagnosed as a low back pain by the investigators, the main site of low back pain locating lower than the twelfth dorsal vertebra, nd pain assessment of >40 mm (using the VAS) by the patients
3) Duration of disease: The current low back pain persisting for at least 3 months
4) Duration of treatment: Any
5) Sleep disorder: PSQI score >6
6) Patients for whom written Informed Consent has been obtained from the patient personally in this study prior to study initiation.
Key exclusion criteria 1) Patients with low back pain associated with neurogenic or neurological signs and symptoms and evident neurogenic symptoms in the area from the buttocks to legs.
2) Patients for whom NSAID therapy is determined to be not suitable by the investigators due to a history of psychiatric disorder, such as depression, or uncontrollable chronic disease.
3) Patients who are scheduled to receive surgical therapy during the study period.
4) Patients who underwent surgery for the treatment of low back pain during the past 6 months.
5) Patients with a history of rheumatoid arthritis, seronegative spondyloarthropathy,metastasis of tumor, etc., Paget's disease, fibromyalgia, spinal or intervertebral disc tumor or infection, or other disease causing generalized pain.
6) Patients with low back pain caused by trauma within 6 months before study enrollment.
7) Patients with low back pain attributable to visceral disease.
8) Patients who received adrenocortical hormone by oral,intramuscular,epidural or perineural administration within 4 weeks before the treatment initiation.
9) Patients with a history of hypersensitivity to the ingredients of celecoxib, sulfonamide or loxoprofen sodium.
10) Patients with a current or past history of aspirin-induced asthma.
11) Patients with peptic and/or gastroduodental ulcers less than 90 days before randomization.
12) Patients with serious liver disorder, renal impairment or cardiac dysfunction.
13) Patients in the perioperative period of coronary artery bypass revascularization.
14) Women at the end of pregnancy.
15) Patients with diseases that strongly affect sleep such as depression, schizophrenia, bipolar disorder, Parkinson's disease, sleep apnoea syndrome,restless legs syndrome, urological diseases with nocturia,and skin diseases with itching.
16) Patients who participated in other clinical studies within the last 3 months.
17) Other patients considered unsuited for the study by their doctors.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsunori Inagaki
Organization Showa University School of
Medicine
Division name Department of Orthopaedic Surgery
Zip code
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Showa University School of
Division name Department of Orthopaedic Surgery
Zip code
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666
TEL
Homepage URL
Email

Sponsor
Institute Department of Orthopaedic Surgery, Showa University School of
Medicine
Institute
Department

Funding Source
Organization Department of Orthopaedic Surgery, Showa University School of
Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2012 Year 09 Month 10 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 11 Month 14 Day
Last modified on
2014 Year 06 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010959

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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