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Neuropathic PainPhase 2NCT01869569

Effect of Pregabalin in Patients With Radiotherapy-related Neuropathic Pain

A Phase 2 study testing Pregabalin in people with Neuropathic Pain, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 4 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Rationale: Pregabalin is effective on radiotherapy-related neuropathic pain. Purpose: This randomized, double-blind, placebo-controlled trial aims to investigate the effect and safety of pregabalin in treating radiotherapy-related neuropathic pain. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neuropathic Pain
What is being tested?
Pregabalin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
137 participants
Where
4 sitesChina
Study dates
Feb 2013to Jan 2017
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have received radiation therapy for histologically confirmed head and neck cancer.
  • Clinical evidence support the diagnosis of radiation-related neuropathic pain (confirmed by the Michigan Neuropathy Screening Instrument) and had a daily pain score of 4 or higher based on a numerical rating scale (0-10 points).
  • Neuropathic pain defined according to clinical history, symptoms, physical signs, and a score>= 12 in Chinese version of Leeds Assessment of Neuropathic Symptoms and Signs questionnaire by two neurology specialists.
  • The mean duration of pain is more than 4 weeks.
  • Fertile women who are willing to take contraception during the trial.
  • Routine laboratory studies with bilirubin </=2 * upper limits of normal (ULN), aspartate aminotransferase (AST or SGOT) < 2 * ULN, creatinine <1.0 * ULN, red-cell count >/= 4,000 per cubic millimeter; white-cell count >/=1500 per cubic millimeter, platelets >/= 75,000 per cubic millimeter; Hb >/=9.0.
  • Ability to understand and willingness to sign a written informed consent document.

Who cannot join

  • Current diagnosis of tumor recurrence or metastasis and evidence of tumor associated pain.
  • Evidence of secondary neuropathic pain other than radiation.
  • Treatment with carbamazepine, gabapentin or pregabalin within 30 days before study enrollment.
  • Ongoing treatment for neuropathic pain.
  • History of anaphylactic response to pregabalin.
  • Evidence of sever systematic diseases.

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • Cancer Center of Sun Yat-sen University

    Guangzhou, Guangdong, 510060

  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

    Guangzhou, Guangdong, 510120

  • Guangzhou Huiai Hospital

    Guangzhou, Guangdong, 510450

  • Zengcheng People's Hospital

    Guangzhou, Guangdong, 511300

Other trials in China

About this study

Official title: Effect of Pregabalin in Patients With Radiotherapy-Related Neuropathic Pain: a Randomized, Double-blind, Placebo-controlled Trial

Rationale: Pregabalin is effective on radiotherapy-related neuropathic pain. Purpose: This randomized, double-blind, placebo-controlled trial aims to investigate the effect and safety of pregabalin in treating radiotherapy-related neuropathic pain.

Read the detailed description

Radiotherapy for cancer is associated with peripheral neuropathies, especially with brachial plexus neuropathy and trigeminal neuralgia, which included painful sensation that are described as burning, aching, spasm, or tingling. Though there is some recommendation about neuropathic pain, there is no definite drug which is recommended for radiotherapy-related neuropathic pain.

Pregabalin, a central nervous system(CNS)-active compound, is an analog of the neurotransmitter gamma-aminobutyric acid. It has been proved an effective treatment for diabetic peripheral neuropathy and postherpetic neuralgia in previous clinical trials. This study plans to evaluate the efficacy of pregabalin versus placebo for relieving radiotherapy-related peripheral neuropathic pain, and assessed its safety.

Being tested
Pregabalin, Placebo
Keywords
Radiation, Neuropathic Pain, Pregabalin
Medical subject headings
Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PregabalinDrug

    Also called Lyrica

    At the 4-week dose-titration phase, will receive one capsule of pregabalin (75 mg) twice daily from Day 1 to Day 7, and two capsules of pregabalin (150 mg) twice daily from Day 8 to Day 14. From Day 15 to Day 28, patients will perform dosage adjustments based on the pain relief and tolerability. At maintenance phase, patients will take the optimized dosage of pregabalin.

  • PlaceboDrug

    At the 4-week dose-titration phase, will receive one capsule of placebo twice daily from Day 1 to Day 7, and two capsules of placebo twice daily from Day 8 to Day 14. From Day 15 to Day 28, patients will perform dosage adjustments based on the pain relief and tolerability. At maintenance phase, patients will take the optimized dosage of placebo.

Study groups in NCT01869569
Study groupRoleWhat they receive
PregabalinActive comparatorArm I:At the 4-week dose-titration phase, will receive one capsule of pregabalin (75 mg) twice daily from Day 1 to Day 7, and two capsules of pregabalin (150 mg) twice daily from Day 8 to Day 14. From Day 15 to Day 28, patients will perform dosage adjustments based on the pain relief and tolerability. At maintenance phase, patients will take the optimized dosage of pregabalin.
Receives: Drug: Pregabalin
PlaceboPlacebo comparatorArm II:At the 4-week dose-titration phase, will receive one capsule of placebo twice daily from Day 1 to Day 7, and two capsules of placebo twice daily from Day 8 to Day 14. From Day 15 to Day 28, patients will perform dosage adjustments based on the pain relief and tolerability. At maintenance phase, patients will take the optimized dosage of placebo.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Numeric Rating Scale (NRS) at week 16

    The primary efficacy measure is the reduction of NRS from baseline to week 16.

    Measured: week 16

Secondary outcomes (5)

  1. Brief Pain Inventory (BPI)

    The investigators compare the BPI scores at week 16 with those at baseline.

    Measured: week 16

  2. the Profile of Mood States-Short Form (POMS-SF)

    The investigators compare the POMS-SF scores at week 16 with those at baseline.

    Measured: week 16

  3. the World Health Organization Quality of Life-BREF (WHOQOL-BREF)

    The investigators compare the WHOQOL-BREF scores at week 16 with those at baseline.

    Measured: week 16

  4. Patient Global Impression of Change (PGIC)

    Number of Participants With Treatment Success at the End of Therapy as Measured by the Patient Global Impression of Change (PGIC). A treatment success is defined as Much or Very Much Improved at the Week 16. The PGIC is a 7-point Likert Scale, ranging from very much worse to very much improved

    Measured: week 16

  5. Clinical Global Impression of Change (CGIC)

    Number of Participants With Treatment Success at the End of Therapy Based on Clinical Global Impression of Change (CGIC) . A treatment success is defined as Much or Very Much Improved at the Week 16. The PGIC is a 7-point Likert Scale, ranging from very much worse to very much improve.

    Measured: week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2013 (estimated)
  2. Study startFeb 2013
  3. Primary completionOct 2016
  4. Study completionJan 2017

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
137 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01869569
Sponsor's protocol ID
2012026
Other IDs
SYSN002
Status last verified
May 2018
First submitted
26 May 2013
Last updated
25 May 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Jiang J, Li Y, Shen Q, Rong X, Huang X, Li H, Zhou L, Mai HQ, Zheng D, Chen MY, Xu Y, Li J, Hui X, Simone CB 2nd, Gaertner J, Argyriou AA, Chow E, Chen P, Tang Y. Effect of Pregabalin on Radiotherapy-Related Neuropathic Pain in Patients With Head and Neck Cancer: A Randomized Controlled Trial. J Clin Oncol. 2019 Jan 10;37(2):135-143. doi: 10.1200/JCO.18.00896. Epub 2018 Nov 20.

    PubMed 30457920

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pregabalin in people with Neuropathic Pain, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 4 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 25 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numeric Rating Scale (NRS) at week 16 (time frame: week 16). 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 NCT01869569, 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 25 May 2018.

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