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

Bausch Health

Status and phase: Completed; Phase 2

Conditions: Constipation

Treatments: Drug: SP-333 6 mg; Drug: Placebo; Drug: SP-333 3 mg; Drug: SP-333 1 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01983306

SP333201-01

Details and patient eligibility

About

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.

Enrollment: 292 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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292 participants in 4 patient groups, including a placebo group

SP-333 1 mg

Experimental group

Description:

1 mg SP-333 orally once daily for 4-week Treatment Period

Treatment:

Drug: SP-333 1 mg

SP-333 3 mg

Experimental group

Description:

3 mg SP-333 orally once daily for 4-week Treatment Period

Treatment:

Drug: SP-333 3 mg

SP-333 6 mg

Experimental group

Description:

6 mg SP-333 orally once daily for 4-week Treatment Period

Treatment:

Drug: SP-333 6 mg

Placebo

Placebo Comparator group

Description:

Placebo orally once daily for 4-week Treatment Period

Treatment:

Drug: Placebo