Dose-ranging Study to Assess Safety and Efficacy of SP-333 for the Treatment of Opioid-induced Constipation (OIC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Synergy Pharmaceuticals Inc.
Sponsor:
Information provided by (Responsible Party):
Synergy Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01983306
First received: October 29, 2013
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to evaluate the safety and efficacy of a range of oral SP-333 doses for the treatment of opioid-induced constipation (OIC) in adults with non-cancer pain taking opioids.


Condition Intervention Phase
Constipation
Drug: SP-333 1 mg
Drug: SP-333 3 mg
Drug: SP-333 6 mg
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, 4-Week, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety and Efficacy of SP-333 for the Treatment of Opioid-induced Constipation (OIC) in Patients With Non-malignant Chronic Pain Receiving Opioid Therapy

Resource links provided by NLM:


Further study details as provided by Synergy Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Change from baseline in the number of spontaneous bowel movements during Week 4 of the 4-week treatment period [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
    Compare SP-333 (1, 3 & 6 mg) with placebo in the treatment of OIC as measured by the change from baseline in the number of spontaneous bowel movements during Week 4 of the 4-week treatment period


Secondary Outcome Measures:
  • To assess safety and tolerability of SP-333 in the treatment of non-malignant OIC [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Compare the safety and tolerability of SP-333 (1, 3 & 6 mg) with placebo as measured by rates of adverse events, clinical laboratory abnormalities and significant changes in vital signs and ECGs.


Other Outcome Measures:
  • To evaluate stool consistency over the 4-week Treatment Period [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Compare SP-333 (1, 3 & 6 mg) with placebo in rates of change from baseline in stool consistency over the 4 weeks of treatment.

  • To evaluate constipation-related symptoms over the 4-week Treatment Period [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Compare SP-333 (1, 3 & 6 mg) with placebo in rates of change from baseline in constipation-related symptoms over the 4 weeks of treatment.

  • To evaluate bowel movement frequency responder rates [Complete Spontaneous Bowel Movements (CSBMs) and Spontaneous Bowel Movements (SBMs)] over the 4-week Treatment Period. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Compare SP-333 (1, 3 & 6 mg) with placebo in rates of change from baseline for bowel movement frequency responder rates [Complete Spontaneous Bowel Movements (CSBMs) and Spontaneous Bowel Movements (SBMs)] over the 4 weeks of treatment.


Estimated Enrollment: 260
Study Start Date: November 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SP-333 1 mg
1 mg SP-333 orally once daily for 4-week Treatment Period
Drug: SP-333 1 mg
Tablet
Experimental: SP-333 3 mg
3 mg SP-333 orally once daily for 4-week Treatment Period
Drug: SP-333 3 mg
Tablet
Experimental: SP-333 6 mg
6 mg SP-333 orally once daily for 4-week Treatment Period
Drug: SP-333 6 mg
Tablet
Placebo Comparator: Placebo
Placebo orally once daily for 4-week Treatment Period
Drug: Placebo
Tablet

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be receiving chronic, stable opioid therapy to treat non-malignant pain for at least 3 months prior to screening
  • Must have active OIC at screening
  • Active OIC must be confirmed during baseline screening bowel habit and symptom diary
  • Must be on stable diet

Exclusion Criteria:

  • Has history of chronic therapy for chronic constipation prior to start of opioid therapy, or any potential non-opioid cause of bowel dysfunction that may be a major contributor to the constipation (i.e., mechanical obstruction or pseudo-obstruction)
  • Use of medications that might affect bowel movement frequency or constipation-related symptoms (e.g., prokinetics, anti-diarrheal agents, laxatives other than study-defined rescue laxative)
  • Has history of or current cancer (other than basal cell or squamous cell carcinoma of the skin) unless the malignancy has been in complete remission without maintenance chemotherapy for at least 5 years
  • Unstable thyroid disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01983306

Contacts
Contact: Renata Tenenbaum 212-584-7608 rtenenbaum@synergypharma.com
Contact: Patrick H Griffin, M.D. 212-584-7606 pgriffin@synergypharma.com

  Show 45 Study Locations
Sponsors and Collaborators
Synergy Pharmaceuticals Inc.
Investigators
Study Director: Renata Tenenbaum Synergy Pharmaceuticals Inc.
  More Information

No publications provided

Responsible Party: Synergy Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01983306     History of Changes
Other Study ID Numbers: SP333201-01
Study First Received: October 29, 2013
Last Updated: May 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Synergy Pharmaceuticals Inc.:
Constipation
Opioid
GC C Agonist
Pain

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants

ClinicalTrials.gov processed this record on July 24, 2014