Back to results

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

Primary Purpose

HIV Infections, Peripheral Neuropathy

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

pregabalin

Placebo

About this trial

This is an interventional treatment trial for HIV Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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). Exclusion Criteria: 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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

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).

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)

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])

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).

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).

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

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).

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.

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.

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.

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

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

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

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

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

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

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

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

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

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.

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.

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.

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.

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.

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)

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).

Full Information

NCT ID

NCT00232141

First Posted

September 30, 2005

Last Updated

January 21, 2021

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00232141

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

June 2009

Overall Recruitment Status

Completed

Study Start Date

October 2005 (undefined)

Primary Completion Date

November 2007 (Actual)

Study Completion Date

November 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections, Peripheral Neuropathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

302 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

pregabalin

Intervention Description

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)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

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

Description

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).

Time Frame

Baseline, Week 14

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline, Week 14

Title

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

Description

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

Time Frame

Baseline, Week 14

Title

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

Description

Time Frame

Baseline, Week 14

Title

Change From Baseline for NRS-Sleep Interference Scores

Description

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

Time Frame

Baseline, Week 14

Title

Categorized Patient Global Impression of Change (PGIC)

Description

Time Frame

Baseline, Week 14

Title

Patient Global Impression of Change (PGIC) Rating

Description

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).

Time Frame

Baseline, Week 14, Endpoint-LOCF

Title

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

Description

Time Frame

Baseline, Week 14

Title

Change in Quantitative Assessment of Neuropathic Pain (QANeP)

Description

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).

Time Frame

Baseline, Week 14

Title

Change in NRS-Sleep Interference Scores

Description

Time Frame

Baseline, Weeks 1-14

Title

Shift in Hospital Anxiety and Depression (HADS) Subscales

Description

Time Frame

Baseline, Week 14

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame