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

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ClinicalTrials.gov Identifier: NCT01983306
Recruitment Status : Completed
First Posted : November 13, 2013
Last Update Posted : October 4, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Constipation Drug: SP-333 1 mg Drug: SP-333 3 mg Drug: SP-333 6 mg Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : November 2013
Primary Completion Date : September 2014
Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Change from baseline in the number of spontaneous bowel movements during Week 4 of the 4-week treatment period [ Time Frame: 4 Weeks ]
    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 :
  1. To assess safety and tolerability of SP-333 in the treatment of non-malignant OIC [ Time Frame: 4 weeks ]
    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:
  1. To evaluate stool consistency over the 4-week Treatment Period [ Time Frame: 4 weeks ]
    Compare SP-333 (1, 3 & 6 mg) with placebo in rates of change from baseline in stool consistency over the 4 weeks of treatment.

  2. To evaluate constipation-related symptoms over the 4-week Treatment Period [ Time Frame: 4 weeks ]
    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.

  3. 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 ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01983306


  Show 42 Study Locations
Sponsors and Collaborators
Synergy Pharmaceuticals Inc.
Investigators
Study Director: Renata Tenenbaum Synergy Pharmaceuticals Inc.
More Information

Responsible Party: Synergy Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01983306     History of Changes
Other Study ID Numbers: SP333201-01
First Posted: November 13, 2013    Key Record Dates
Last Update Posted: October 4, 2017
Last Verified: October 2017

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
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents