Safety Study to Assess Opiate Withdrawal Signs and Symptoms in Opioid Dependent Patients

Pfizer

Status and phase: Terminated; Phase 4

Conditions: Chronic Pain

Treatments: Drug: EMBEDA™ (morphine sulfate/naltrexone hydrochloride) whole; Drug: EMBEDA™ (morphine sulfate/naltrexone hydrochloride) crush

Study type: Interventional

Funder types: Industry

Identifiers

NCT01100437

ALO-01-09-111

B4541002

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 14 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic moderate to severe non-cancer pain that has been treated with opioid analgesics for at least three months (with stabilized pain control and stabilized dose for 28 days prior to enrollment).
• Receiving an opioid dose equivalent to 20 mg - 120 mg morphine once or twice daily.
• Patient displays signs and symptoms of withdrawal (i.e., COWS score ≥5) following naloxone administration during the Naloxone Challenge.

If female and able to become pregnant, must use an approved method of birth control.

• Excluding the chronic moderate to severe non-cancer pain, the patient is judged by the Investigator to be in generally good health at screening based upon the results of a medical history, physical examination, laboratory profile, and 12 lead electrocardiogram (ECG).

Exclusion criteria

• Female who is pregnant or breastfeeding.
• Patient has a known allergy or history of significant adverse reaction to morphine, other opioids, naltrexone, acetaminophen, or related compounds.
• Patient is receiving systemic chemotherapy, has an active malignancy of any type, or has been diagnosed with cancer within the 5 years prior to screening (excluding squamous or basal cell carcinoma of the skin).
• History of, or ongoing, alcohol or drug abuse.
• Patient has made a donation of blood or has had a significant blood loss within 30 days prior to screening.

Trial design

14 participants in 2 patient groups

EMBEDA™ (morphine sulfate/naltrexone hydrochloride) crush

Experimental group

Description:

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.

Treatment:

Drug: EMBEDA™ (morphine sulfate/naltrexone hydrochloride) crush

EMBEDA™ (morphine sulfate/naltrexone hydrochloride) whole

Experimental group

Description:

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

Treatment:

Drug: EMBEDA™ (morphine sulfate/naltrexone hydrochloride) whole