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| ID | Type | Description | Link |
|---|---|---|---|
| B4541002 |
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See termination reason in detailed description.
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This study will evaluate whether crushed EMBEDA capsules induce clinical opiate withdrawal signs and symptoms in opioid-dependent patients with chronic non-cancer pain who are stabilized on EMBEDA.
The decision to terminate the trial was due to a lack of study drug supply. Decision was not based on any safety concerns. The date of the notification of termination letter was March 11, 2011.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMBEDA™ (morphine sulfate/naltrexone hydrochloride) crush | Experimental | EMBEDA (morphine sulfate plus naltrexone hydrochloride ER) capsules crushed and mixed in solution and administered orally at each patient's stable dose, given either once daily or twice daily. |
|
| EMBEDA™ (morphine sulfate/naltrexone hydrochloride) whole | Experimental | EMBEDA (morphine sulfate plus naltrexone hydrochloride ER) capsules, administered orally and intact at each patient's stable dose, given either once daily or twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMBEDA™ (morphine sulfate/naltrexone hydrochloride) crush | Drug | Placebo capsules plus EMBEDA capsules crushed and mixed in solution administered orally at each patient's stable dose, given either once daily or twice daily |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinical Opiate Withdrawal Scale (COWS) Score Greater Than or Equal to (≥) 13 in the Treatment Phase | COWS is an 11 section clinical assessment of withdrawal symptoms, each section is rated from 0 (no symptom) to 4 or 5 (most severe symptom). Total score is classified into a 4 point rating scale (mild 5-12, moderate 13-24, moderately severe 25-36 and severe more than 36 points). | Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24 hours (hr) post-dose and unscheduled assessment (UA) |
| Measure | Description | Time Frame |
|---|---|---|
| Average Numeric Pain Rating Scale (NPRS) in Titration/Stabilization and Maintenance Phases | Average pain scores in the previous 24 hours using an 11 point NPRS ranging from no pain (0) to worst pain (10). | Baseline up to Day 63 |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) During the Treatment Phase |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Occurrence of a COWS Score ≥ 13 for Each Treatment During the Treatment Phase | Average time to first occurrence of a COWS score ≥ 13 | Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24 hr post-dose and UA |
| Morphine Plasma Concentration at First COWS ≥ 13 in the Treatment Phase |
Inclusion Criteria:
If female and able to become pregnant, must use an approved method of birth control.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lifetree Clinical Research | Salt Lake City | Utah | 84106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23709323 | Derived | Setnik B, Roland CL, Goli V, Sommerville K, Webster L. A clinical trial to determine if corelease of morphine and naltrexone from crushed extended-release capsules induces withdrawal in opioid-dependent patients: a descriptive analysis of six patients. J Opioid Manag. 2013 Mar-Apr;9(2):139-50. doi: 10.5055/jom.2013.0155. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | EMBEDA Capsule Then EMBEDA Solution | EMBEDA (morphine sulfate plus naltrexone hydrochloride) Extended Release (ER) capsule(s) were administered orally once or twice a day (20 milligrams [mg] to 120 mg). During the open label titration and stabilization phase EMBEDA was administered and titrated to a dose that adequately managed the participants pain up to 35 days. In the open label Maintenance Phase the participant was administered the established stable dose for a minimum of 7 days up to 28 days. The participant was then randomized to one of two double-blind treatment sequences for the Treatment Phase. During the Treatment Phase the participant was administered whole EMBEDA capsules orally at participant's stable dose along with a matched placebo solution in the first intervention period. In the second intervention period the participant received crushed EMBEDA capsules that were mixed in solution and administered orally at participant's stable dose along with matched placebo capsules. |
| FG001 | EMBEDA Solution Then EMBEDA Capsule | EMBEDA (morphine sulfate plus naltrexone hydrochloride) ER capsule(s) were administered orally once or twice a day (20 mg to 120 mg). During the open label titration and stabilization phase EMBEDA was administered and titrated to a dose that adequately managed the participants pain up to 35 days. In the open label Maintenance Phase the participants were administered the established stable dose for a minimum of 7 days up to 28 days. The participant was then randomized to one of two double-blind treatment sequences for the Treatment Phase. During the Treatment Phase the participant was administered crushed EMBEDA capsules orally at participants stable dose mixed in solution along with matched placebo capsules in the first intervention period. In the second intervention period the participant received whole EMBEDA capsules administered orally at participant's stable dose along with matched placebo solution. |
| FG002 | EMBEDA Capsule | EMBEDA (morphine sulfate plus naltrexone hydrochloride) ER capsule(s) were administered orally once or twice a day (20 mg to 120 mg). During the titration and stabilization phase EMBEDA was administrated and titrated to a dose that adequately managed the participants pain for up to 35 days. In the Maintenance Phase the participant's were administered the established stable dose for a minimum of 7 days up to 28 days. Participants were not randomized to treatment phase. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Screening |
| |||||||||||||
| Titration/Stabilization |
| |||||||||||||
| Maintenance |
| |||||||||||||
| Treatment 1 |
| |||||||||||||
| Washout (4 Days) |
| |||||||||||||
| Treatment 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | EMBEDA (morphine sulfate plus naltrexone hydrochloride) ER capsule(s) were administered orally once or twice a day (20 mg to 120 mg). During the titration and stabilization phase EMBEDA was administered and titrated to a dose that adequately managed the participant's pain up to 35 days. The participants then started the Maintenance Phase and were administered the established stable dose of EMBEDA for a minimum of 7 days up to 28 days. Eligible participants were randomized into the 2 treatment groups. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Clinical Opiate Withdrawal Scale (COWS) Score Greater Than or Equal to (≥) 13 in the Treatment Phase | COWS is an 11 section clinical assessment of withdrawal symptoms, each section is rated from 0 (no symptom) to 4 or 5 (most severe symptom). Total score is classified into a 4 point rating scale (mild 5-12, moderate 13-24, moderately severe 25-36 and severe more than 36 points). | Intent-to-treat population (ITT): all randomized participants who received at least one dose of double-blind treatment in the Treatment Phase and had at least one post-dose pharmacodynamic assessment completed in the Treatment Phase. | Posted | Number | participants | Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24 hours (hr) post-dose and unscheduled assessment (UA) |
|
Study procedure related adverse events (AEs) were collected from the time of written Informed Consent and all other AEs from the time of the first dose of EMBEDA at Visit 2.
The same event may appear as both an AE and a serious adverse events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EMBEDA Whole Capsule Treatment Period | EMBEDA whole capsules, administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (unspecified) | Non-systematic Assessment |
Sponsor terminated study early on 10-Mar-2011.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D013375 | Substance Withdrawal Syndrome |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C550436 | morphine, naltrexone combination |
| D009020 | Morphine |
| D009271 | Naltrexone |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| EMBEDA™ (morphine sulfate/naltrexone hydrochloride) whole | Drug | EMBEDA capsules, administered orally and intact at each patient's stable dose, given either once daily or twice daily with 150mL placebo solution |
|
Average Tmax for Morphine, Naltrexone and 6-β-Naltrexol |
| Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose |
| Maximum Observed Plasma Concentration (Cmax) During the Treatment Phase | Average Cmax for Morphine, Naltrexone and 6-β-Naltrexol | Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose |
| Minimum Observed Plasma Concentration (Cmin) During the Treatment Phase | Average Cmin for Morphine, Naltrexone and 6-β-Naltrexol | Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose |
| Apparent Oral Clearance (CL/F) During the Treatment Phase | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose |
| Volume of Distribution (Vd/F)During the Treatment Phase | Average Vd/F for Morphine, Naltrexone and 6-β-Naltrexol | Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose |
| Plasma Decay Half-Life (t1/2) During the Treatment Phase | Average plasma decay half-life of morphine, naltrexone and 6-β-Naltrexol. Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose |
| Area Under the Curve From Time Zero to End of Dosing Interval (AUC0-τ) During the Treatment Phase | Average AUC0-τ for Morphine, Naltrexone and 6-β-Naltrexol reported. τ=24 hours | Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose |
| Area Under the Curve From Time Zero to the Time of Last Measurable Concentration (AUC0-last) During the Treatment Phase | Average AUC0-last for Morphine, Naltrexone and 6-β-Naltrexol. Area under the plasma concentration time-curve from time zero to the last measured concentration. | Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] During the Treatment Phase | AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). Average AUC 0-∞ for Morphine, Naltrexone and 6-β-Naltrexol reported. | Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose |
| Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose |
| Naltrexone Plasma Concentration at First COWS ≥ 13 in the Treatment Phase | Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose |
| 6-β-Naltrexone Plasma Concentration at First COWS ≥ 13 in Treatment Phase | Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose |
| Maximum Post-dose COWS in the Treatment Phase | COWS is an 11 section clinical assessment of withdrawal symptoms, each section is rated from 0 (no symptom) to 4 or 5 (most severe symptom). Total score is classified into a 4 point rating scale (mild 5-12, moderate 13-24, moderately severe 25-36 and severe more than 36 points). | Between 0.5 and 24 hours post-dose |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | EMBEDA Crushed in Solution | EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period. |
|
|
| Secondary | Average Numeric Pain Rating Scale (NPRS) in Titration/Stabilization and Maintenance Phases | Average pain scores in the previous 24 hours using an 11 point NPRS ranging from no pain (0) to worst pain (10). | ITT; N=number of participants with evaluable data; n=number of participants evaluated at the specific time point | Posted | Mean | Standard Deviation | units on a scale | Baseline up to Day 63 |
|
|
|
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) During the Treatment Phase | Average Tmax for Morphine, Naltrexone and 6-β-Naltrexol | Pharmacokinetic (PK) population: all randomized participants who received at least one dose of EMBEDA (whole or crushed) in the Treatment Phase and had at least one PK assessment completed in the Treatment Phase; n=number of participants with evaluable data for the specific category | Posted | Mean | Standard Deviation | hours (h) | Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose |
|
|
|
| Secondary | Maximum Observed Plasma Concentration (Cmax) During the Treatment Phase | Average Cmax for Morphine, Naltrexone and 6-β-Naltrexol | PK population; n=number of participants with evaluable data for specific category | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose |
|
|
|
| Secondary | Minimum Observed Plasma Concentration (Cmin) During the Treatment Phase | Average Cmin for Morphine, Naltrexone and 6-β-Naltrexol | PK population; n=number of participants with evaluable data for specific category | Posted | Mean | Standard Deviation | ng/mL | Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose |
|
|
|
| Secondary | Apparent Oral Clearance (CL/F) During the Treatment Phase | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | PK population; N=number of participants with evaluable data; n=number of participants with evaluable data for the specific category | Posted | Mean | Standard Deviation | liters/hour (L/h) | Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose |
|
|
|
| Secondary | Volume of Distribution (Vd/F)During the Treatment Phase | Average Vd/F for Morphine, Naltrexone and 6-β-Naltrexol | PK population; N=number of participants with evaluable data; n=number of participants with evaluable date for the specific category | Posted | Mean | Standard Deviation | liter (L) | Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose |
|
|
|
| Secondary | Plasma Decay Half-Life (t1/2) During the Treatment Phase | Average plasma decay half-life of morphine, naltrexone and 6-β-Naltrexol. Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | PK population; N=number of participants with evaluable data; n=number of participants with evaluable data for the specific category | Posted | Mean | Standard Deviation | h | Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose |
|
|
|
| Secondary | Area Under the Curve From Time Zero to End of Dosing Interval (AUC0-τ) During the Treatment Phase | Average AUC0-τ for Morphine, Naltrexone and 6-β-Naltrexol reported. τ=24 hours | PK population; n=number of participants with evaluable data for the specific category | Posted | Mean | Standard Deviation | ng times h divided by mL (ng*h/mL) | Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose |
|
|
|
| Secondary | Area Under the Curve From Time Zero to the Time of Last Measurable Concentration (AUC0-last) During the Treatment Phase | Average AUC0-last for Morphine, Naltrexone and 6-β-Naltrexol. Area under the plasma concentration time-curve from time zero to the last measured concentration. | PK population; n=number of participants with evaluable data for the specific category | Posted | Mean | Standard Deviation | ng*h/mL | Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose |
|
|
|
| Secondary | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] During the Treatment Phase | AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). Average AUC 0-∞ for Morphine, Naltrexone and 6-β-Naltrexol reported. | PK population; N=number of participants with evaluable data; n=number of participants with evaluable data for the specific category | Posted | Mean | Standard Deviation | ng*h/mL | Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose |
|
|
|
| Other Pre-specified | Time to First Occurrence of a COWS Score ≥ 13 for Each Treatment During the Treatment Phase | Average time to first occurrence of a COWS score ≥ 13 | ITT; Subset of participants with COWS >= 13 | Posted | Mean | Standard Error | h | Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24 hr post-dose and UA |
|
|
|
| Other Pre-specified | Morphine Plasma Concentration at First COWS ≥ 13 in the Treatment Phase | ITT; Subset of participants with COWS ≥ 13 | Posted | Mean | Standard Deviation | ng/mL | Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose |
|
|
|
| Other Pre-specified | Naltrexone Plasma Concentration at First COWS ≥ 13 in the Treatment Phase | ITT; Subset of participants with COWS ≥ 13 | Posted | Mean | Standard Deviation | picogram/milliliter (pg/mL) | Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose |
|
|
|
| Other Pre-specified | 6-β-Naltrexone Plasma Concentration at First COWS ≥ 13 in Treatment Phase | ITT; Subset of all participants with COWS ≥ 13 | Posted | Mean | Standard Deviation | pg/mL | Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose |
|
|
|
| Other Pre-specified | Maximum Post-dose COWS in the Treatment Phase | COWS is an 11 section clinical assessment of withdrawal symptoms, each section is rated from 0 (no symptom) to 4 or 5 (most severe symptom). Total score is classified into a 4 point rating scale (mild 5-12, moderate 13-24, moderately severe 25-36 and severe more than 36 points). | ITT | Posted | Mean | Standard Deviation | units on a scale | Between 0.5 and 24 hours post-dose |
|
|
|
| 0 |
| 6 |
| 4 |
| 6 |
| EG001 | EMBEDA Crushed in Solution Treatment Period | EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo whole capsules in any treatment period . | 0 | 6 | 6 | 6 |
| EG002 | EMBEDA Capsule Titration/Stabilization Period | EMBEDA capsule(s) administered orally once or twice a day (20 mg go 120 mg) to adequately manage the participants pain. | 0 | 14 | 12 | 14 |
| EG003 | EMBEDA Capsules Maintenance Period | EMBEDA capsule(s) administered orally once or twice a day dose (20 mg go 120 mg) at the participants stable dose for 7 days minimum. | 0 | 8 | 1 | 8 |
| Tremor | Nervous system disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Restless legs syndrome | Nervous system disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Retching | Gastrointestinal disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Yawning | Respiratory, thoracic and mediastinal disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Irritability | General disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Mydriasis | Eye disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (unspecified) | Non-systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA (unspecified) | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Euphoric mood | Psychiatric disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA (unspecified) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (unspecified) | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D009270 | Naloxone |
|
| Titration/Stabilization-Visit 2d (n=1) |
|
| Maintenance (n=6) |
|
| 6-β-Naltrexol (n=4,6) |
|
| 6-β-Naltrexol (n=4,6) |
|
| 6-β-Naltrexol (n=4,6) |
|
| 6-β-Naltrexol (n=3,6) |
|
| 6-β-Naltrexol (n=3,6) |
|
| 6-β-Naltrexol (n=3,6) |
|
| 6-β-Naltrexol (n=4,6) |
|
| 6-β-Naltrexol (n=4,6) |
|
| 6-β-Naltrexol (n=3,6) |
|