Back to resultsThe Efficacy and Safety of Pregabalin Release Tablets for the Treatment of Fibromyalgia
Primary Purpose
Fibromyalgia
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Pregabalin Release Tablets
Pregabalin Release Tablets
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia
Eligibility Criteria
Inclusion Criteria:
- Patients who met the 1990 American College of Rheumatology (ACR) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites).
Patients who completed at least 4 pain diaries within the last 7 days and the average pain score must have been ≥4, and had a score of ≥40 mm on the Visual Analogue Scale (VAS) at screening and randomization .
Exclusion Criteria:
- Patients with other severe pain that may confound assessment or self-evaluation of the pain associated with fibromyalgia.
Patients with any inflammatory muscle or rheumatologic disease other than fibromyalgia, active infections, or untreated endocrine disorders.
Sites / Locations
- Xiehe Hospital of BeijingRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
330mg/day
495mg/day
Placebo
Arm Description
330 mg QD taken orally,1 pills once ,one time a day in an hour after meals, oral administration for 15 weeks (3 week titration and 12-week fixed dose)
495 mg QD taken orally,2 pills once ,one time a day in an hour after meals, oral administration for 15 weeks (3 week titration and 12-week fixed dose)
1 or 2 pills once ,one time a day in an hour after meals, oral administration for 15 weeks (3 week titration and 12-week fixed dose)
Outcomes
Primary Outcome Measures
Change from baseline in mean pain score diary at Endpoint
derived from the subject's daily pain
Secondary Outcome Measures
Change from baseline in FIQ scores at Weeks 15
Change from baseline in SF-36 scores at Weeks 15
Change from baseline in HADS scores at Weeks 15
Change from baseline in MOS-SS scores at Weeks 15
Quality of Sleep Score from the Daily Sleep Diary
Mean pain score from the subject's daily pain
Full Information
NCT ID
NCT02868814
First Posted
July 29, 2016
Last Updated
August 11, 2016
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02868814
Brief Title
The Efficacy and Safety of Pregabalin Release Tablets for the Treatment of Fibromyalgia
Official Title
The Efficacy and Safety of Pregabalin Release Tablets for the Treatment of Fibromyalgia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
May 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the Efficacy and safety of pregabalin sustained release tablets versus placebo for fibromyalgia
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
330mg/day
Arm Type
Experimental
Arm Description
330 mg QD taken orally,1 pills once ,one time a day in an hour after meals, oral administration for 15 weeks (3 week titration and 12-week fixed dose)
Arm Title
495mg/day
Arm Type
Experimental
Arm Description
495 mg QD taken orally,2 pills once ,one time a day in an hour after meals, oral administration for 15 weeks (3 week titration and 12-week fixed dose)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1 or 2 pills once ,one time a day in an hour after meals, oral administration for 15 weeks (3 week titration and 12-week fixed dose)
Intervention Type
Drug
Intervention Name(s)
Pregabalin Release Tablets
Intervention Type
Drug
Intervention Name(s)
Pregabalin Release Tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change from baseline in mean pain score diary at Endpoint
Description
derived from the subject's daily pain
Time Frame
Baseline and 15 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in FIQ scores at Weeks 15
Time Frame
Baseline and Weeks 15
Title
Change from baseline in SF-36 scores at Weeks 15
Time Frame
Baseline and Weeks 15
Title
Change from baseline in HADS scores at Weeks 15
Time Frame
Baseline and Weeks 15
Title
Change from baseline in MOS-SS scores at Weeks 15
Time Frame
Baseline and Weeks 15
Title
Quality of Sleep Score from the Daily Sleep Diary
Time Frame
up to 15 weeks
Title
Mean pain score from the subject's daily pain
Time Frame
up to 15 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who met the 1990 American College of Rheumatology (ACR) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites).
Patients who completed at least 4 pain diaries within the last 7 days and the average pain score must have been ≥4, and had a score of ≥40 mm on the Visual Analogue Scale (VAS) at screening and randomization .
Exclusion Criteria:
Patients with other severe pain that may confound assessment or self-evaluation of the pain associated with fibromyalgia.
Patients with any inflammatory muscle or rheumatologic disease other than fibromyalgia, active infections, or untreated endocrine disorders.
Facility Information:
Facility Name
Xiehe Hospital of Beijing
City
Beijing
State/Province
Beijing
ZIP/Postal Code
UN
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wu Qingjun, M.D.
Phone
UN
Email
wuqingjun@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Efficacy and Safety of Pregabalin Release Tablets for the Treatment of Fibromyalgia
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