HealthyPhase 1NCT01119222
Study To Assess The Effect Of Gabapentin, Diphenhydramine And Morphine On Cold Pain In Healthy Male Volunteers
A Phase 1 study testing Gabapentin, Diphenhydramine and Morphine in people with Healthy, run by Pfizer at 1 site in Belgium.
Trial summary
Human experimental pain models are useful in understanding the mechanisms underlying clinical pain conditions and can be used to test the analgesic efficacy of drugs used in the management of pain. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Gabapentin, Diphenhydramine and Morphine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2008to Oct 2008
- Phase
- Phase 1
- 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 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers having given consent to participate in the study who have no clinically significant anomalies and whose vital signs are within normal range.
- Subject having performed the cold pain test reproducibly ie, if the area under the pain-time curve (AUC) must be within 20% during successive tests within one cold pain test screening visit and within 30% between the two cold pain test screening visits.
Who cannot join
- Subject who have had a serious adverse reaction or significant hypersensitivity to any of the study drugs.
- Subjects with a history of or evidence of any neurological condition which could affect pain sensation.
- Subjects with an AUCcpt 0-120 sec in the cold pain test of <1000 in any of the screening tests (excluding familiarization).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-Blind, Double-Dummy, Placebo And Active Controlled, 4-Way Crossover Methodology Study To Assess The Effect Of Gabapentin, Diphenhydramine And Morphine On Cold Pain In Healthy Male Volunteers
Human experimental pain models are useful in understanding the mechanisms underlying clinical pain conditions and can be used to test the analgesic efficacy of drugs used in the management of pain. Once established these models can be used as mechanism biomarkers in early development clinical studies to establish proof of mechanism for novel compounds. The cold pain model is a mechanistic pain biomarker with potential application in proof of mechanism studies. In this study we aim to set up this cold pain model at a Clinical Research Unit and demonstrate we can effectively screen subjects for this model and examine the effect of morphine, diphenhydramine, and gabapentin in the cold pain model.
Read the detailed description
Cold pain methodology development
- Conditions
- Healthy
- Being tested
- Gabapentin, Diphenhydramine, Morphine, Placebo
- Keywords
- Cold pain methodology, Healthy male volunteers, gabapentin, Diphenhydramine, morphine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Capsule, single 1200mg dose
DiphenhydramineDrug
Tablet, single 50mg dose
MorphineDrug
IV, single 10mg dose
PlaceboDrug
Placebo formulations (Capsule, tablet, IV to match the active treatments and to be administered in a double-dummy fashion).
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin 1200mg | Active comparator | Not described Receives: Drug: Gabapentin |
| Diphenhydramine 50 mg | Active comparator | Not described Receives: Drug: Diphenhydramine |
| Morphine 10 mg | Active comparator | Not described Receives: Drug: Morphine |
| Placebo formulations | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Pain (0-120 Seconds): Cold Pain Test Visual Analog Scale (VAS)
Area under the cold pain test Visual Analog Scale (VAS) time curve (AUCcpt 0 to 120 seconds [sec]) averaged over the 120 sec for each time point assessed. Participant adjusted 100 millimeter (mm) electronic VAS with range of "no pain" (0) to "maximum pain" (100) at the anchor endpoints of the scale and "moderate pain" at the midpoint. Pain reported while non-dominant hand was placed in thermostatically controlled water bath at 2±1°C for a maximum of 120 sec.
Measured: Pre-dose, 1, 1.5, 2, 4, and 8 hours post-dose
Interpolated Average Pain (0-8 Hours)
Interpolated average pain (0 to 8 hours): area under the curve (AUC) of average pain (0 to 120 seconds) recorded at each of the time points taken over 8 hour time period divided by 8.
Measured: Pre-dose to 8 hours post-dose
Secondary outcomes (6)
Number of Participants With Clinically Significant Findings in Vital Signs
Supine blood pressure measured to nearest millimeter of mercury (mmHg), pulse rate measured with automated device or manually in the brachial/radial artery for at least 30 seconds.
Measured: Predose, Day 1, Day 2 each treatment period, follow-up visit (at least 7 days after last dosing)
Number of Participants With Clinically Significant Abnormal Findings on Physical Examination
Full physical examination consisting of an examination of the abdomen, cardiovascular systems, lungs, lymph nodes, mouth, musculoskeletal and neurological systems, skin, extremities, head, ears, eyes, nose, throat and thyroid gland.
Measured: Pre-dose and follow-up visit (at least 7 days after last dosing)
Number of Participants With Abnormal Findings on Electrocardiogram (ECG)
Standard 12-lead ECG performed after subject had rested quietly for at least 10 minutes in a supine position.
Measured: Pre-dose and follow-up visit (at least 7 days after last dosing)
Number of Participants With Abnormal Haematology, Clinical Chemistry, Urinalysis Results
Standard haematology, clinical chemistry, and urinalysis safety laboratory tests.
Measured: Pre-dose, follow-up visit (at least 7 days after last dosing)
Number of Participants With Abnormal Cardiac Monitoring Results
Continuous cardiac monitoring during intervenous (IV) infusion dosing (morphine or placebo).
Measured: Pre-dose through duration of IV infusion dosing
Number of Participants With Abnormal Pulse Oxymetry Results
Pulse oxymetry to monitor percentage of hemoglobin saturated with oxygen during intervenous (IV) infusion dosing (morphine or placebo).
Measured: Predose through duration of IV infusion dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2010 (estimated)
- Study startJul 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01119222
- Sponsor's protocol ID
- A9001388
- Status last verified
- Feb 2011
- First submitted
- 5 May 2010
- Last updated
- 7 Mar 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind, Double-Dummy, Placebo And Active Controlled, 4-Way Crossover Methodology Study To Assess The Effect Of Gabapentin, Diphenhydramine And Morphine On Cold Pain In Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01119222
- Acronym / sponsor ID
- A9001388
- Conditions
- Healthy
- Keywords
- Cold pain methodology, Healthy male volunteers, gabapentin, Diphenhydramine, morphine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 7 May 2010 (estimated)
- Results
- Posted 7 Mar 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Human experimental pain models are useful in understanding the mechanisms underlying clinical pain conditions and can be used to test the analgesic efficacy of drugs used in the management of pain. Once established these models can be used as mechanism biomarkers in early development clinical studies to establish proof of mechanism for novel compounds. The cold pain model is a mechanistic pain biomarker with potential application in proof of mechanism studies. In this study we aim to set up this cold pain model at a Clinical Research Unit and demonstrate we can effectively screen subjects for this model and examine the effect of morphine, diphenhydramine, and gabapentin in the cold pain model.
Detailed description
Cold pain methodology development
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Gabapentin 1200mg | Active comparator | Drug: Gabapentin |
| Diphenhydramine 50 mg | Active comparator | Drug: Diphenhydramine |
| Morphine 10 mg | Active comparator | Drug: Morphine |
| Placebo formulations | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male volunteers having given consent to participate in the study who have no clinically significant anomalies and whose vital signs are within normal range.
- Subject having performed the cold pain test reproducibly ie, if the area under the pain-time curve (AUC) must be within 20% during successive tests within one cold pain test screening visit and within 30% between the two cold pain test screening visits.
Key exclusion criteria (3 listed)
- Subject who have had a serious adverse reaction or significant hypersensitivity to any of the study drugs.
- Subjects with a history of or evidence of any neurological condition which could affect pain sensation.
- Subjects with an AUCcpt 0-120 sec in the cold pain test of <1000 in any of the screening tests (excluding familiarization).
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 |
|---|---|---|
| GabapentinCapsule, single 1200mg dose | Drug | Gabapentin 1200mg |
| DiphenhydramineTablet, single 50mg dose | Drug | Diphenhydramine 50 mg |
| MorphineIV, single 10mg dose | Drug | Morphine 10 mg |
| PlaceboPlacebo formulations (Capsule, tablet, IV to match the active treatments and to be administered in a double-dummy fashion). | Drug | Placebo formulations |
Primary outcome
Average Pain (0-120 Seconds): Cold Pain Test Visual Analog Scale (VAS)
Time frame: Pre-dose, 1, 1.5, 2, 4, and 8 hours post-dose
Area under the cold pain test Visual Analog Scale (VAS) time curve (AUCcpt 0 to 120 seconds [sec]) averaged over the 120 sec for each time point assessed. Participant adjusted 100 millimeter (mm) electronic VAS with range of "no pain" (0) to "maximum pain" (100) at the anchor endpoints of the scale and "moderate pain" at the midpoint. Pain reported while non-dominant hand was placed in thermostatically controlled water bath at 2±1°C for a maximum of 120 sec.
Interpolated Average Pain (0-8 Hours)
Time frame: Pre-dose to 8 hours post-dose
Interpolated average pain (0 to 8 hours): area under the curve (AUC) of average pain (0 to 120 seconds) recorded at each of the time points taken over 8 hour time period divided by 8.
6 secondary outcomes
Number of Participants With Clinically Significant Findings in Vital Signs
Time frame: Predose, Day 1, Day 2 each treatment period, follow-up visit (at least 7 days after last dosing)
Number of Participants With Clinically Significant Abnormal Findings on Physical Examination
Time frame: Pre-dose and follow-up visit (at least 7 days after last dosing)
Number of Participants With Abnormal Findings on Electrocardiogram (ECG)
Time frame: Pre-dose and follow-up visit (at least 7 days after last dosing)
Number of Participants With Abnormal Haematology, Clinical Chemistry, Urinalysis Results
Time frame: Pre-dose, follow-up visit (at least 7 days after last dosing)
Number of Participants With Abnormal Cardiac Monitoring Results
Time frame: Pre-dose through duration of IV infusion dosing
Number of Participants With Abnormal Pulse Oxymetry Results
Time frame: Predose through duration of IV infusion dosing
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gabapentin, Diphenhydramine and Morphine in people with Healthy, run by Pfizer at 1 site in Belgium.
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 2 inclusion and 3 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 7 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 7 Mar 2011). 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?
Average Pain (0-120 Seconds): Cold Pain Test Visual Analog Scale (VAS) (time frame: Pre-dose, 1, 1.5, 2, 4, and 8 hours post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2011.