MDACC Study Summary 2003-0722

Study Summary
No. 2003-0722:.......Other Supportive......Allen W. Burton......Anesthesiology

Study Summary Title



Study Summary Number:	2003-0722

Study Title:	A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase IIb Study to Evaluate the Efficacy and Safety of Multiple Alvimopan Dosage Regimens for the Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects

Physician

New Patient Referral



Name:	Allen W. Burton	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Anesthesiology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-7246 Contact us about clinical trials

General Information



Disease Group:	Other Supportive	Supported By:	GlaxoSmithKline

Phase of Study:	Phase II	Return Visit:	THE PATIENT WILL RETURN TO MDACC FOR A MINIMUM OF 5 VISITS.

Treatment Agents:	Screening Collection Data Base alvimopan	Home Care:	NONE

Treatment Loc:	outpatient

Estimated Length of Stay in Houston:	THE STUDY VISITS WLL BE ON AN OUTPATIENT BASIS.


Description/ Intervention:	Unavailable

Study Objectives / Outcomes

Unavailable

Study Status Information



Study Activation / Registration Date:	05/27/2004

IRB Review and Approval Date:	12/03/2003

Study Type:	Therapeutic

Recruitment Status:	Closed

Projected Accrual:	25

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

Subject is male or female, 18 years or older at the time of the Screening visit.

The opioid therapy is dosed chronically for at least one month prior to the Screening visit at a minimum daily dose of at least 30 mg. oral morphine equivalents.

The opioid therapy is dosed stably (+40% total daily dose) for at least one week prior to the Screening visit and without any dose reductions.

Subject meets the protocol-definition of opioid-induced bowel dysfunction as follows: Since starting opioid therapy, a history based on subject recall of decreased BM frequency and the occurrence of at least one of the following subjective BM symptoms - incomplete evacuation, hard stools, straining).

Compliance with the guidance for maintenance and rescue laxative use (See Sections 7,11,13, and 7.14).

Subject understands the procedures, agrees to participate in the study, and had signed and dated the informed consent form prior to the initiation of any study related activities, including discontinuation of pre-study laxative regimen or other prohibited medications.

Subject is female and is currently either of (a) non-childbearing potential or (b) childbearing potential, has a negative serum B-hCG pregnancy test at the Screening visit, and agrees to use acceptable contraception throughout the study until the clinic follow-up 14 days after the last dose of investigational produce. See protocol for additional information regarding this criteria.

Opioid therapy admin orally, transdermally, intravenously, or subcutaneously.

Note 1. The patient-controlled analgesia (PCA) pump route of chronic admin is permitted only if the basal rate of chronically dosed opioid meets all requirements set forth in elig crit, if opioid admin on demand for breakthrough pain is not suggestive of unstable dosing, and if the total daily dose of opioid admin both chronically and on demand can be reported in the CRF

Note 2. The intrathecal pump (intraspinal) route of chronic opioid admin is permitted only if the subject is taking another chronically dosed opioid that meets all of the requirements set forth in the elig crit and if the total daily dose of the intrathecally admin opioid can be reported in the CRF

Subject has a minimum life expectancy of greater than or equal to 3 months at the time of the Screening Visit.

To be randomized on Day 1, a confirmed 1-week baseline history based on diary data of the 3 following criteria: (1) Decreased BM frequency: less than 3 spontaneous complete BMs/week and more than 0 BMs/week. (2) Occurrence of at least one of the subjective BM symptom(s): (a) sensation of incomplete evacuation for 25% of BMs, (b) lumpy hard stools or small pellets for 25% or more of BMs, and/or (c) straining for 25% or more of BMs.

Subject is capable of completing the Daily Diary, is able and willing to comply with daily and weekly data collection via the Daily Diary (as confirmed by at least 80% compliance during the Baseline Period) and is capable of completing the paper questionnaires.

Pt who has cancer or is in remission from a recent cancer, and is taking opioid therapy for continued intractable pain. Pain examples include, but are not limited to, (1) tumor-related pain, even if the tumor is no longer present but has caused lasting damage and (2) pain related to cancer therapy such as post surgical pain, pain related to radiation treatment, or pain related to chemotherapy.

Exclusion Criteria:

Subject is not ambulatory (e.g., bed or wheel chair bound).

Subject is unable to eat or drink. Subjects who are unable to take oral medications or to hold down oral medications due to vomiting are excluded.

Subject is taking opioids for the management of drug addiction.

Subject is taking opiods that are mixed agonists/antagonists or partial agonists. (Exception: Tramadol is permitted on an as needed basis for breakthrough pain, see Section 8.3).

Subject has severe constipation that has not been appropriately managed such that the subject is at immediate risk of developing serious complications. The would include a subject who has reported no BM for 7 consecutive days prior to the Screening visit.

Subject with GI or pelvic disorders known to affect bowel transit, produce GI obstruction, or contribute to bowel dysfunction.

Subject has symptomatic primary or secondary (from metastatic disease) brain tumor.

Subject is currently taking vinca alkyloids or plans to take them during the study. Subject who has experienced paralytic ileus or intestinal pseudo obstruction associated with past chemo treatment (e.g., taxanes, vinca alkyloids).

Subject with chronic fecal incontinence.

Subject is taking antidiarrheals (e.g., loperamide), has an incidence of diarrhea or loose stools in the 2 wks prior to the Screening Visit or a history of intermittent diarrhea, loose stools or irritable bowel syndrome (IBS) symptoms which are consistent with the Rome II Criteria (see Section 14.4, Appendix 4).

Subject has undergone prior radiation therapy that resulted in documented chronic radiation enteritis or radiation stricture, has undergone abdominal radiation therapy in the past 2 wks prior to the Screening Visit, is currently undergoing abdominal radiation therapy and/or plans to under abdominal radiation therapy during the study.

Subject has clinically significant laboratory abnormalities prior to randomization that are: suggestive of primary hepatic dysfunction or active viral hepatitis as evidenced by serum ALT (SGPT) or AST (SGOT) values equal to or greater than 5 times the upper limit of normal, or bilirubin values equal to or greater than 2 times the upper limit of normal.

Subject has a history of alcohol and/or substance abuse within the past 2 years.

Subject has any other known condition or physical examination finding prior to Randomization, which could contraindicate participation in this study.

Note 3. All other routes of chronic administration of opioid therapy are excluded

Subject has participated in another trial with an investigational drug, device or procedure within 30 days prior to Screening Visit. Subject has been randomized to investigational product in this study (SB-767905/008) or has been treated with alvimopan in another trial at anytime in the past.

Subject is unable or unwilling to discontinue the use of and/or refrain from using stool softeners and laxatives of all types and formulations at the screening visit and throughout the baseline and treatment periods.

Subject is unable or unwilling to refrain from facilitating defecation via manual maneuvers (digital manipulation) throughout the baseline and treatment periods. Prestudy dietary fiber intake from eating whole foods and use of bulk forming agents is not increased.

Con-meds with known attribution to constipation are allowed if in the PI?s opinion, the opioid therapy & not the con-med is the predominant cause of constipation & if the dose of the con-med has been constant for 2 wks prior to the Screening Visit & is expected to remain constant throughout the Treatment Period.

Chronic con-meds used to control a current medical condition are allowed if the dose of the con-med has been constant for 2 wks prior to the Screening Visit, the dose is expected to remain constant throughout the Treatment Period & use of the con-med would not otherwise contraindicate participation in this study.

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