Postherpetic NeuralgiaPhase 3EASOPSRTFPNCT02868801
Efficacy and Safety of Pregabalin Sustained Release Tablet for Postherpetic Neuralgia
A Phase 3 study testing Pregabalin SR tablet 165mg/day, Pregabalin SR tablet 330mg/day and Pregabalin SR tablet 660mg/day in people with Postherpetic Neuralgia, run by Jiangsu HengRui Medicine Co., Ltd. at 27 sites in China.
Trial summary
The purpose of this study is to evaluate the Efficacy and safety of pregabalin sustained release tablet versus placebo for postherpetic neuralgia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postherpetic Neuralgia
- What is being tested?
- Pregabalin SR tablet 165mg/day, Pregabalin SR tablet 330mg/day and Pregabalin SR tablet 660mg/day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 27 sitesChina
- Study dates
- Mar 2015to Jun 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatient ，Patients can not stay in the hospital overnight；
- Patients must have pain present for more than 3 months after the healing of the herpes zoster skin rash；
- At least 4 days and at least 8 pain diaries(Pain Numeric Rating Scale) must be completed satisfactorily within the seven days of single-blind, placebo run-in period, and the average pain score must be greater than or equal to 4；
- At screening (V0) and enrollment (V1), patients must have a score of greater than or equal to 40 mm on the 100 mm pain visual analog scale；
- Women were neither pregnant nor lactating, and those of childbearing age had a confirmed negative serum pregnancy test at baseline and practiced an appropriate method of contraception throughout the study.
Who cannot join
- Decrease of ≥30% on their pain VAS or ≥ 4 between any two pain diaries during the placebo run-in period.( in order to remove potential placebo-responders)；
- Patients who had failed to respond to previous treatment for PHN with gabapentin at doses ≥1200 mg/day ；
- History of using pregabalin or participation in a previous trial of pregabalin；
- Patients with a skin condition or severe non-PHN pain that might impair the self assessment of pain caused by PHN；
- Patients with other Nervous system disorders which might impair completing the pain diaries or sleep interference diaries；
- History of epilepsy and being treated by drug therapy；
Show all 17Show fewer
- Previous surgical therapy for PHN；
- History of using effective therapies during 2 weeks before screening (V0),eg: acupuncture and moxibustion, Transcutaneous Electrical Nerve Stimulation；
- Potentially retinal toxicity of drugs past or now；
- Prohibited medications without appropriate washout；
- Malignancy within the past 2 years；
- Laboratory examination: WBC<2.5×109/L；ANC<1.5×109/L；PLT<100×109/L；ALT/AST>3ULN；
- Creatinine clearance ≤ 60 mL/min；
- Positive antibody of Hepatitis c，Human immunodeficiency virus ，Treponema pallidum ；
- Patients who are allergic to or intolerant of pregabalin or other drugs which have a similarly chemical structure ；
- History of illicit drug or alcohol abuse within the last 2 years；
- Clinically significant or unstable hepatic, respiratory, or hematologic illnesses or psychologic conditions; unstable cardiovascular disease which may increase the risk of participation the clinical trial in the opinion of the study investigator.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
China27 sites, 27 recruiting
- Recruiting
Beijing Chao-yang Hospital
Beijing, Beijing Municipality
- Recruiting
Beijing Friendship Hospital ,Capital Medical University
Beijing, Beijing Municipality
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality
- Recruiting
The Affiliated Hospital of Jilin University
Changchun, Jilin
- Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
- Recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian
- Recruiting
Sun Yat-Sen Memory Hospital , Sun Yat-Sen University
Guangzhou, Guangdong
- Recruiting
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou
- Recruiting
The Affiliated Hospital of Hainan Medical College
Haikou, Hainan
- Recruiting
Hangzhou First People's Hospital
Hangzhou, Zhejiang
- Recruiting
The First Affiliated Hospital , Zhejiang University
Hangzhou, Zhejiang
- Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui
- Recruiting
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan
- Recruiting
Qingdao Municipal Hospital(Group)
Qingdao, Shandong
- Recruiting
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
- Recruiting
Shengjing Hospital Of China Medical University
Shengyang, Liaoning
- Recruiting
The People's Hospital of Liaoning Province
Shenyang, Liaoning
- Recruiting
Fourth Hospital Of Hebei Medical University
Shijiazhuang, Hebei
- Recruiting
The Second Hospital Of Hebei Medical University
Shijiazhuang, Hebei
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu
- Recruiting
First Hospital Of Shanxi Medical University
Taiyuan, Shanxi
- Recruiting
Second Hospital Of Shanxi Medical University
Taiyuan, Shanxi
- Recruiting
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang
- Recruiting
Xinjiang Uygur Autonomous Region Hospital OF TCM
Ürümqi, Xinjiang
- Recruiting
Xijing Hospital; the Fourth Military Medical University
Xi’an, Shanxi
- Recruiting
Yancheng City NO.1 People's Hospital
Yancheng, Jiangsu
About this study
Official title: Efficacy and Safety of Pregabalin Sustained Release Tablet for Postherpetic Neuralgia -A Multicenter,Randomized, Double-blind, Placebo-controlled Trial
The purpose of this study is to evaluate the Efficacy and safety of pregabalin sustained release tablet versus placebo for postherpetic neuralgia.
Read the detailed description
This is a randomized, double-blind, multicenter, placebo-controlled trial to compare the efficacy and safety of pregabalin SR vs placebo in patients with PHN.
The study is conducting at 27 study centers in China. Patients were randomized to receive pregabalin, starting at 165 mg/day and increasing to a maintenance dose of 330 or 660 mg/day, or placebo.
The study includes a 1-week, single-blind, placebo run-in period; a 2-week dose-escalation/optimization phase; a 12-week, fixed-dose treatment period; and a 1-week taper phase.
- Conditions
- Postherpetic Neuralgia
- Being tested
- Placebo, Pregabalin SR tablet 165mg/day, Pregabalin SR tablet 330mg/day, Pregabalin SR tablet 660mg/day
- Keywords
- Pregabalin
- Medical subject headings
- Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Placebo tablet of pregabalin sustained release tablet
same intervention as the experimental group
Pregabalin SR tablet 165mg/dayDrug
Also called Pregabalin sustained release tablet
According to the efficacy and safety in titration
Pregabalin SR tablet 330mg/dayDrug
Also called Pregabalin sustained release tablet
According to the efficacy and safety in titration
Pregabalin SR tablet 660mg/dayDrug
Also called Pregabalin sustained release tablet
According to the efficacy and safety in titration.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | placebo, oral administration for 14 weeks (2 week titration and 12-week fixed dose) Receives: Drug: Placebo |
| Pregabalin SR tablet 165mg/day | Experimental | 1pills once ,one time a day in an hour after meals, oral administration for 14 weeks (2 week titration and 12-week fixed dose) Receives: Drug: Pregabalin SR tablet 165mg/day |
| Pregabalin SR tablet 330mg/day | Experimental | 1pills once ,one time a day in an hour after meals, oral administration for 14 weeks (2 week titration and 12-week fixed dose) Receives: Drug: Pregabalin SR tablet 330mg/day |
| Pregabalin SR tablet 660mg/day | Experimental | 2pills once ,one time a day in an hour after meals, oral administration for 14 weeks (2 week titration and 12-week fixed dose) Receives: Drug: Pregabalin SR tablet 660mg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Responders
A responder is defined as a subject with a 30% reduction in weekly mean pain score from baseline to endpoint
Measured: 15 weeks
Secondary outcomes (3)
50% reduction in weekly mean pain score from baseline to study completion
Measured: 15 weeks
Change of Mean Pain Scores from study completion to baseline
Measured: 15 weeks
Change of Mean Sleep Interference Scores from study completion to baseline
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startMar 2015
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postherpetic NeuralgiaStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lu Qianjin, M.D., Principal investigator, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02868801
- Sponsor's protocol ID
- HRPRBL-PHN
- Acronym
- EASOPSRTFP
- Status last verified
- Feb 2016
- First submitted
- 8 Jul 2015
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
van Seventer R, Feister HA, Young JP Jr, Stoker M, Versavel M, Rigaudy L. Efficacy and tolerability of twice-daily pregabalin for treating pain and related sleep interference in postherpetic neuralgia: a 13-week, randomized trial. Curr Med Res Opin. 2006 Feb;22(2):375-84. doi: 10.1185/030079906x80404.
PubMed 16466610
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Pregabalin Sustained Release Tablet for Postherpetic Neuralgia -A Multicenter,Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT02868801
- Acronym / sponsor ID
- EASOPSRTFP / HRPRBL-PHN
- Conditions
- Postherpetic Neuralgia
- Keywords
- Pregabalin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 16 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the Efficacy and safety of pregabalin sustained release tablet versus placebo for postherpetic neuralgia.
Detailed description
This is a randomized, double-blind, multicenter, placebo-controlled trial to compare the efficacy and safety of pregabalin SR vs placebo in patients with PHN.
The study is conducting at 27 study centers in China. Patients were randomized to receive pregabalin, starting at 165 mg/day and increasing to a maintenance dose of 330 or 660 mg/day, or placebo.
The study includes a 1-week, single-blind, placebo run-in period; a 2-week dose-escalation/optimization phase; a 12-week, fixed-dose treatment period; and a 1-week taper phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placeboplacebo, oral administration for 14 weeks (2 week titration and 12-week fixed dose) |
| Pregabalin SR tablet 165mg/day | Experimental | Drug: Pregabalin SR tablet 165mg/day1pills once ,one time a day in an hour after meals, oral administration for 14 weeks (2 week titration and 12-week fixed dose) |
| Pregabalin SR tablet 330mg/day | Experimental | Drug: Pregabalin SR tablet 330mg/day1pills once ,one time a day in an hour after meals, oral administration for 14 weeks (2 week titration and 12-week fixed dose) |
| Pregabalin SR tablet 660mg/day | Experimental | Drug: Pregabalin SR tablet 660mg/day2pills once ,one time a day in an hour after meals, oral administration for 14 weeks (2 week titration and 12-week fixed dose) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Outpatient ，Patients can not stay in the hospital overnight；
- Patients must have pain present for more than 3 months after the healing of the herpes zoster skin rash；
- At least 4 days and at least 8 pain diaries(Pain Numeric Rating Scale) must be completed satisfactorily within the seven days of single-blind, placebo run-in period, and the average pain score must be greater than or equal to 4；
- At screening (V0) and enrollment (V1), patients must have a score of greater than or equal to 40 mm on the 100 mm pain visual analog scale；
- Women were neither pregnant nor lactating, and those of childbearing age had a confirmed negative serum pregnancy test at baseline and practiced an appropriate method of contraception throughout the study.
Key exclusion criteria (17 listed)
- Decrease of ≥30% on their pain VAS or ≥ 4 between any two pain diaries during the placebo run-in period.( in order to remove potential placebo-responders)；
- Patients who had failed to respond to previous treatment for PHN with gabapentin at doses ≥1200 mg/day ；
- History of using pregabalin or participation in a previous trial of pregabalin；
- Patients with a skin condition or severe non-PHN pain that might impair the self assessment of pain caused by PHN；
- Patients with other Nervous system disorders which might impair completing the pain diaries or sleep interference diaries；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: Placebo tablet of pregabalin sustained release tabletsame intervention as the experimental group | Drug | Placebo |
| Pregabalin SR tablet 165mg/dayAlso: Pregabalin sustained release tabletAccording to the efficacy and safety in titration | Drug | Pregabalin SR tablet 165mg/day |
| Pregabalin SR tablet 330mg/dayAlso: Pregabalin sustained release tabletAccording to the efficacy and safety in titration | Drug | Pregabalin SR tablet 330mg/day |
| Pregabalin SR tablet 660mg/dayAlso: Pregabalin sustained release tabletAccording to the efficacy and safety in titration. | Drug | Pregabalin SR tablet 660mg/day |
Primary outcome
Number of Responders
Time frame: 15 weeks
A responder is defined as a subject with a 30% reduction in weekly mean pain score from baseline to endpoint
3 secondary outcomes
50% reduction in weekly mean pain score from baseline to study completion
Time frame: 15 weeks
Change of Mean Pain Scores from study completion to baseline
Time frame: 15 weeks
Change of Mean Sleep Interference Scores from study completion to baseline
Time frame: 15 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.
- Results publication: PubMed 16466610van Seventer R, Feister HA, Young JP Jr, Stoker M, Versavel M, Rigaudy L. Efficacy and tolerability of twice-daily pregabalin for treating pain and related sleep interference in postherpetic neuralgia: a 13-week, randomized trial. Curr Med Res Opin. 2006 Feb;22(2):375-84. doi: 10.1185/030079906x80404.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lu Qianjin, M.D. principal investigator
Second Xiangya Hospital of Central South University
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pregabalin SR tablet 165mg/day, Pregabalin SR tablet 330mg/day and Pregabalin SR tablet 660mg/day in people with Postherpetic Neuralgia, run by Jiangsu HengRui Medicine Co., Ltd. at 27 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liang Yunsheng, M.D. (UN, liangyunsheng@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Responders (time frame: 15 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02868801, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2016.