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HIV InfectionsPhase 3NCT00232141

Study of Pregabalin Versus Placebo in the Treatment of Nerve Pain Associated With HIV Neuropathy

A Phase 3 study testing pregabalin in people with HIV Infections and Peripheral Neuropathy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 44 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

Study to determine if pregabalin is more effective than placebo in treating subjects with nerve pain associated with HIV neuropathy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections, Peripheral Neuropathy
What is being tested?
pregabalin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
302 participants
Where
44 sitesin 2 countries
Study dates
Oct 2005to Nov 2007
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Subjects with confirmed diagnosis of HIV infection
  • HIV-associated neuropathic pain (nerve pain) for at least 3 months prior to study start
  • subjects with moderate to severe pain
  • subjects on stable HIV and pain medications (some medications are not allowed to be taken while participating in the study).

Who cannot join

  • Pregnant or breast feeding females
  • subjects using street drugs or alcohol abusers during the study
  • subject's on anti-diabetic medications
  • use of neuroregenerative agents or neurotoxic chemotherapeutic agents 3 months prior to study start and throughout the study
  • use of neurotoxic drugs (other than D-drugs) within a month prior to study start and throughout the study.

Trial locations and contacts

44 sites in 2 countries.

44 sites in 2 countries

United States41 sites

  • Pfizer Investigational Site

    Atlanta, Georgia, 30309

  • Pfizer Investigational Site

    Austin, Texas, 78705

  • Pfizer Investigational Site

    Baltimore, Maryland, 21287-7609

  • Pfizer Investigational Site

    Birmingham, Alabama, 35294

  • Pfizer Investigational Site

    Boston, Massachusetts, 02215

  • Pfizer Investigational Site

    Chicago, Illinois, 60611

  • Pfizer Investigational Site

    Chicago, Illinois, 60612

  • Pfizer Investigational Site

    Dallas, Texas, 75204

  • Pfizer Investigational Site

    Dallas, Texas, 75208-4234

  • Pfizer Investigational Site

    Dallas, Texas, 75208

  • Pfizer Investigational Site

    Dallas, Texas, 75219

  • Pfizer Investigational Site

    Dallas, Texas, 75390-9036

  • Pfizer Investigational Site

    Denver, Colorado, 80262

  • Pfizer Investigational Site

    Honolulu, Hawaii, 96816

  • Pfizer Investigational Site

    Little Rock, Arkansas, 72207

  • Pfizer Investigational Site

    Longview, Texas, 75605

  • Pfizer Investigational Site

    Los Angeles, California, 90025

  • Pfizer Investigational Site

    Los Angeles, California, 90028

  • Pfizer Investigational Site

    Miami, Florida, 33133

  • Pfizer Investigational Site

    Milwaukee, Wisconsin, 53226

  • Pfizer Investigational Site

    New York, New York, 10018

  • Pfizer Investigational Site

    New York, New York, 10021

  • Pfizer Investigational Site

    New York, New York, 10029

  • Pfizer Investigational Site

    Pensacola, Florida, 32504-5719

  • Pfizer Investigational Site

    Philadelphia, Pennsylvania, 19104

  • Pfizer Investigational Site

    Phoenix, Arizona, 85023

  • Pfizer Investigational Site

    Portland, Oregon, 97209

  • Pfizer Investigational Site

    Rochester, New York, 14642

  • Pfizer Investigational Site

    Sacramento, California, 95817-1460

  • Pfizer Investigational Site

    Safety Harbor, Florida, 34695

  • Pfizer Investigational Site

    San Antonio, Texas, 78229

  • Pfizer Investigational Site

    San Diego, California, 92103

  • Pfizer Investigational Site

    San Francisco, California, 94117

  • Pfizer Investigational Site

    Seattle, Washington, 98104

  • Pfizer Investigational Site

    Springfield, Massachusetts, 01107

  • Pfizer Investigational Site

    St Louis, Missouri, 63110-1010

  • Pfizer Investigational Site

    St Louis, Missouri, 63110

  • Pfizer Investigational Site

    Stanford, California, 94301

  • Pfizer Investigational Site

    Vero Beach, Florida, 32960

  • Pfizer Investigational Site

    West Hollywood, California, 90069

  • Pfizer Investigational Site

    West Palm Beach, Florida, 33407

Other trials in United States

Puerto Rico3 sites

  • Pfizer Investigational Site

    Ponce, 00716

  • Pfizer Investigational Site

    San Juan, 00909-1711

  • Pfizer Investigational Site

    San Juan, 00936-0000

Other trials in Puerto Rico

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial of Pregabalin Versus Placebo in the Treatment of Neuropathic Pain Associated With HIV Neuropathy.

Study to determine if pregabalin is more effective than placebo in treating subjects with nerve pain associated with HIV neuropathy.

Being tested
pregabalin, Placebo
Medical subject headings
HIV Infections, Peripheral Nervous System Diseases

What participants receive

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

  • pregabalinDrug

    75mg BID (can be titrated up to 150mg BID on day 4 based on individual response and up to 300mg BID at the end of week 1, visit 3 and end of week 2, visit 4)

  • PlaceboDrug

    Placebo

Study groups in NCT00232141
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: pregabalin
2Placebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline

    Change from baseline in mean NRS-Pain scores at endpoint-LOCF. Daily pain scores were assessed on an 11-point numerical rating scale <(NRS)-Pain> ranging from 0 (no pain) to 10 (worst possible pain).

    Measured: Baseline, Week 14

Secondary outcomes (28)

  1. Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices

    Change from baseline in MOS-Sleep subscales \& Sleep Problem Indices. Twelve item subject-rated questionnaire assessing sleep constructs. Scores range from 0 - 100 and higher scores reflect more impairment. Subscales "sleep adequacy", "quantity of sleep" and "optimal sleep" low scores reflect impairment.

    Measured: Baseline, Week 14

  2. Change From Baseline for Hospital Anxiety and Depression Scale (HADS) Subscales

    Change from Baseline in scale at endpoint: normal (score 0) to severe (score 21).

    Measured: Baseline, Week 14

  3. Change From Baseline for Modified Brief Pain Inventory-Short Form (mBPI-sf) Scores

    Change from baseline to endpoint in the mBPI-sf to assess pain severity and pain interference with functional activities: 11-point scale ranging from "no pain" (0) to "pain as bad as you can imagine" (10)

    Measured: Baseline, Week 14

  4. Change From Baseline for NRS-Sleep Interference Scores

    11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain])

    Measured: Baseline, Week 14

  5. Categorized Patient Global Impression of Change (PGIC)

    The PGIC is a participant-rated instrument that measures change in the participants overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse). PGIC was evaluated using 3 categories of Improvement (Scores 1-3), No Change (Score 4), and Worsening (Scores 5-7).

    Measured: Baseline, Week 14

  6. Patient Global Impression of Change (PGIC) Rating

    PGIC is a participant-rated instrument that measures change in the participants overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse).

    Measured: Baseline, Week 14, Endpoint-LOCF

  7. Change in Neuropathic Pain Symptom Inventory (NPSI) Subscores and Total Intensity Scores

    Change in mean score NPSI, questionnaire evaluates symptoms of neuropathic pain. 10 pain descriptors questions answered on an 11-point scale 0 (no pain)-10 (most intense pain imaginable). 2 items related to temporal pain assessed on 5-point scales. The NPSI derives 5 pain subscores \& a total intensity score calculated from the 5 pain subscores

    Measured: Baseline, Week 14

  8. Change in Quantitative Assessment of Neuropathic Pain (QANeP)

    Change in a quantitative assessment of the participants' neuropathic pain were on an 11-point scale ranging from 0 (no pain) to 10 (most intense pain imaginable).

    Measured: Baseline, Week 14

  9. Change in NRS-Sleep Interference Scores

    Change in mean Pain-related sleep interference was assessed on an 11-point scale from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Weekly mean score was the sum of the daily diary scores divided by the number of diary entries during that week.

    Measured: Baseline, Weeks 1-14

  10. Shift in Hospital Anxiety and Depression (HADS) Subscales

    Anxiety subscale analyzes generalized anxiety (anxious mood,restlessness, anxious thoughts, panic attacks). The depression subscale focuses on the state of lost interest and diminished pleasure response. A score of Normal = 0-7, Mild = 8-10, Moderate = 11-14, Severe = 15-21.

    Measured: Baseline, Week 14

  11. Change in Brief Pain Inventory-short Form (BPI-sf) Scores (The Worst Pain in the Past 24 Hours)

    Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions \& 7 pain interference questions.

    Measured: Baseline, Weeks 1,2,6,10,14, Endpoint - LOCF

  12. Change in Brief Pain Inventory-sf Scores (The Least Pain in the Past 24 Hours)

    Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions \& 7 pain interference questions.

    Measured: Baseline, Weeks 1,2,6,10,14, Endpoint-LOCF

  13. Change in Brief Pain Inventory-sf Scores (Average Level of Pain in the Past 24 Hours)

    Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions \& 7 pain interference questions.

    Measured: Baseline, Weeks 1,2,6,10,14 and Endpoint

  14. Change in Brief Pain Inventory-sf Scores (How Much Pain Are You Having Right Now)

    Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions \& 7 pain interference questions.

    Measured: Baseline, Weeks 1,2,6,10,14 and Endpoint

  15. Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your General Activity)

    Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions \& 7 pain interference questions.

    Measured: Baseline, Weeks 1,2,6,10,14 and Endpoint

  16. Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Mood)

    Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions \& 7 pain interference questions.

    Measured: Baseline, Weeks 1,2,6,10,14 and Endpoint

  17. Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Walking Ability)

    Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions \& 7 pain interference questions.

    Measured: Baseline, Weeks 1,2,6,10,14 and Endpoint

  18. Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Normal Work Including Both Work Outside the Home and Housework)

    Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions \& 7 pain interference questions.

    Measured: Baseline, Weeks 1,2,6,10,14 and Endpoint

  19. Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Relations With Other People)

    Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions \& 7 pain interference questions.

    Measured: Baseline, Weeks 1,2,6,10,14 and Endpoint

  20. Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Sleep)

    Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions \& 7 pain interference questions.

    Measured: Baseline, Weeks 1,2,6,10,14 and Endpoint

  21. Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Enjoyment of Life)

    Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions \& 7 pain interference questions.

    Measured: Baseline, Weeks 1,2,6,10,14 and Endpoint

  22. Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain

    Number of subjects reporting duration of spontaneous pain. The NPSI includes the temporal item for assessment of duration of spontaneous, ongoing and paroxysmal pain. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint.

    Measured: Baseline-Week 14 (Endpoint)

  23. Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks

    Number of subjects reporting pain attacks. The NPSI includes the temporal item for assessing the numbers of pain attacks. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint.

    Measured: Baseline-Week 14 (Endpoint)

  24. Change in Number of Pain Attacks Compared to Baseline - NPSI (Neuropathic Pain Symptom Inventory)

    Change from baseline in the number of pain attacks at endpoint. The NPSI includes the temporal item for assessing the numbers of pain attacks. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint.

    Measured: Baseline, Week 14

  25. Duration of Spontaneous Pain-NPSI (Neuropathic Pain Symptom Inventory)

    Change from baseline to endpoint in the duration of spontaneous pain. The NPSI includes the temporal item for assessment of duration of spontaneous, ongoing and paroxysmal pain. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint.

    Measured: Baseline, Week 14

  26. Gracely Pain Scale Score

    The modified Gracely Pain Scale is a 13-point verbal rating scale based on sensory pain descriptors ranked by severity from nothing (rank = 0) to extremely intense (rank = 15). Subjects selected the verbal descriptors that best matched their average neuropathic pain during the last 24 hours prior to assessment.

    Measured: Week 14

  27. Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table

    Shift from baseline in maximum sensory thresholds (in grams representing the force equivalent of various sizes of von Frey filaments) as measured on QANeP. Improved - decrease in the maximum of the 3 trials at endpoint. Worsened - an increase. Note:Sensory Thresholds are the highest values of the 3 trials at baseline (Week=0) and endpoint (Week 14)

    Measured: Baseline-Week 14 (Endpoint)

  28. Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table

    Shift from baseline in median sensory thresholds (designated as Weight) from 3 trials as measured on the QANeP. Improved - a decrease in the median of the three trials at endpoint. Worsened - an increase. Note: Sensory Thresholds are the highest values of the three Trials at both baseline (Week=0) and endpoint (Week 14).

    Measured: Baseline-Week 14 (Endpoint)

Timeline

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

  1. First posted4 Oct 2005 (estimated)
  2. Study startOct 2005
  3. Primary completionNov 2007
  4. Study completionNov 2007

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
302 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00232141
Sponsor's protocol ID
A0081066
Status last verified
Jun 2009
First submitted
30 Sep 2005
Last updated
9 Feb 2021
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing pregabalin in people with HIV Infections and Peripheral Neuropathy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 44 sites in 2 countries.

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 4 inclusion and 5 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 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States, Puerto Rico. 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?

Yes. Results are posted in the registry (first posted 11 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline (time frame: Baseline, Week 14). 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 NCT00232141.

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 9 Feb 2021.

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